IP UPDATE
Exploring the Latest in Intellectual Property Law
IP UPDATE
Exploring the Latest in Intellectual Property Law
Inter Partes Review (IPR)
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Even a Non-Explicit Claim Construction Can Be Erroneous

by | Feb 15, 2024 |

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board decision finding the challenged patent claims not obvious over the prior art. The Court found that the Board, after concluding that no claim construction was required, implicitly construed the claim limitation at issue and did so erroneously. Google LLC v. EcoFactor, Case Nos. 22-1750; -1767 (Fed. Cir. Feb. 7, 2024) (Reyna, Taranto, Stark, JJ.)

Google filed a petition for inter partes review (IPR) challenging claims of an EcoFactor patent related to dynamic climate control systems that factor outside weather conditions and thermal conditions inside the home to balance comfort and energy savings. The challenged claims define a method for reducing the cycling time of a climate control system involving “retrieving a target time at which [the] structure [(e.g., a house)] is desired to reach a target temperature.” The challenged method claims recite a step of “determining a first time prior to said target time at which [the] climate control system should turn on to reach the target temperature by the target time.” The relevant claim limitation reads:

[D]etermining a first time prior to said target time at which said climate control system should turn on to reach the target temperature by the target time based at least in part on [i] said one or more thermal performance values of said structure, [ii] said performance characteristic of said climate control system, [iii] said first internal temperature, [iv] said first external temperature, and [v] the forecasted temperature.

During the IPR proceedings, the parties disputed whether a prior art reference disclosed a method involving determining a first time prior to the target time based on a first internal temperature. Google argued that the prior art taught a calculation of a first time prior to the target time based on thermal performance values (input [i]) calculated from internal temperature values (input [iii]). EcoFactor argued that each of the inputs in the claim limitation was a distinct value not dependent on or calculated from any other input. Based on the claim language, the Board determined that claim construction was unnecessary and concluded that inputs [i] – [v] of the relevant claim limitation were separate inputs using different data. The Board concluded that Google had not shown that the challenged claims were unpatentable, reasoning that Google’s theory of obviousness relied on a single input as the basis for both input [i] and input [iii].

Google appealed. Google argued that although the Board stated that no construction was necessary, it incorrectly construed the claim limitation to require five discrete inputs.

The Federal Circuit agreed with Google, finding that the Board’s assessment of the claim limitation implicitly established the claim scope by requiring inputs [i] – [v] to be completely separate. The Court reasoned that the plain claim language did not provide any indication that none of the listed inputs could be based on any other input(s). Imputing this requirement into the limitation was therefore an act of claim construction.

The Federal [...]

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Scattered Disclosures May Not Lead to Inference of Fraud in FCA Claim

by | Feb 1, 2024 |

The US Court of Appeals for the Ninth Circuit denied a petition for panel rehearing and rehearing en banc and issued an amended opinion that reversed a district court’s decision regarding the False Claims Act’s (FCA) public disclosure bar. Silbersher v. Valeant Pharm. Int’l, Inc., Case No. 20-16176 (9th Cir. Aug. 3, 2023; amended Jan. 5, 2024) (Schroeder, Sanchez, Antoon, JJ.)

The FCA imposes civil liability on those who knowingly present a fraudulent claim for payment to the federal government and allows “relators” to bring fraud claims on behalf of the government.

Valeant owns a set of patents that cover a delayed-release formula for a medication prescribed to treat ulcerative colitis. In 2015, a generic drug manufacturer, GeneriCo, challenged one of Valeant’s patents in an inter partes review (IPR) proceeding. Ultimately, the Patent Trial & Appeal Board found Valeant’s patent unpatentable based on two articles co-authored by Valeant’s head of research.

Silbersher was GeneriCo’s lawyer in the IPR proceeding. He discovered that three years before applying for the challenged patent, Valeant had applied for another patent that disclosed the exact opposite of what Valeant would claim in the challenged patent. Silbersher brought an FCA action alleging that Valeant failed to disclose this information in the IPR proceeding. In response, Valeant argued that the public disclosure bar applied. The district court decided that an IPR qualified as an “other Federal hearing” under channel (ii) of the public disclosure bar and dismissed Silbersher’s action. Silbersher appealed.

On appeal, the Ninth Circuit reversed the district court. Valeant filed a petition for panel rehearing and rehearing en banc. The Court issued an amended decision that refocused on its analysis under its 2016 decision in Mateski v. Raytheon. Under Mateski, the public disclosure bar applies when “the disclosure at issue occurred through one of the channels specified in the statute; the disclosure was ‘public;’ and the relator’s actions are ‘based upon’ the allegations or transactions publicly disclosed.”

The Ninth Circuit discussed whether Valeant’s disclosures revealed “substantially the same allegations or transactions” as Silbersher’s qui tam action. As discussed in the original decision, this was a first for this court, which had not yet “interpreted substantially the same prong of the public disclosure bar” under the 2010 Congress amendments. Mateski explained that to disclose a public fraudulent transaction according to the formulation X+Y=Z (where Z is the fraud allegation and X and Y are the essential elements), “the combination of X and Y must be revealed from which readers or listeners may infer Z, the conclusion that fraud has been committed.”

The Ninth Circuit then applied the Mateski framework to conclude that the qualifying public disclosures here did not collectively disclose a combination of facts sufficient to permit a reasonable inference of fraud. It explained that although “scattered disclosures when viewed together possibly reveal some of these true and misrepresented facts,” fraud could not reasonably be inferred from the combinations. Neither Valeant’s patent prosecutions nor disclosures revealed the critical information necessary to support [...]

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Keep Calm and Party On: New Issue Prohibition Doesn’t Apply to Motions to Amend

by | Jan 25, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board obviousness determination, explaining that inter partes review (IPR) statutory provisions that prohibit an otherwise time-barred party from introducing new issues into the proceeding do not apply to motions to amend. CyWee Group Ltd. v. ZTE (USA), Inc. et al., Case No. 21-1855 (Fed. Cir. Jan. 18, 2024) (Prost, Hughes, Stoll JJ.)

CyWee owns a patent directed to a “three-dimensional (3D) pointing device capable of accurately outputting a deviation including yaw, pitch and roll angles in a 3D reference frame and preferably in an absolute manner.” ZTE filed a petition for IPR of the patent asserting that certain claims were unpatentable. The Board instituted the IPR. LG later filed an IPR petition challenging the patent and moved to join ZTE’s ongoing IPR, stating that it would “act as a passive ‘understudy’ and [would] not assume an active role unless [ZTE] ceases to participate in the instituted IPR.”

While LG’s motion was pending, CyWee moved to amend its patent claims, contingent on cancellation of the original claims. ZTE opposed the motion to amend. The Board gave preliminary guidance that the proposed claims lacked written description support and introduced new matter, and also that one of the proposed claims was invalid over the asserted prior art.

The Board granted LG’s motion to join ZTE’s IPR proceeding but placed restrictions on LG’s participation that required LG to consolidate filings with ZTE, rely on ZTE to take and defend depositions, refrain from requesting or reserving additional deposition or oral hearing time, and agree to other procedural concessions to minimize delay to the IPR proceeding.

After LG’s joinder, CyWee filed a revised motion to amend. ZTE indicated that it did not oppose the motion. LG, arguing that ZTE was no longer actively participating in the IPR, moved for leave to oppose CyWee’s motion to amend. Ultimately, the Board permitted LG to present argument and evidence independent from ZTE. LG filed an opposition arguing that CyWee’s proposed revised claims were obvious over Withanawasam, Bachmann and Bachmann2. Notably, ZTE had not cited Withanawasam in its opposition to CyWee’s initial motion to amend.

After the Board issued its final decision finding that the proposed revised claims were obvious over Withanawasam, Bachmann and Bachmann2, CyWee appealed.

CyWee argued that the Board erred by allowing LG to oppose CyWee’s motion to amend in a manner that violated the terms of LG’s joinder and by allowing LG to raise Withanawasam in opposition to the motion to amend. The Federal Circuit rejected both arguments. The Court explained that the Board concluded that although ZTE still participated in the IPR, the proceeding “no longer appear[ed] to be meaningfully adversarial” as to the revised motion to amend. The Court found no error in the Board’s conclusion that ZTE was no longer an active participant in the IPR proceeding, and thus there was no violation of the joinder terms.

The Federal Circuit also concluded that the Board did not err [...]

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Don’t Assume Sweet Success: Forum Selection Clause Doesn’t Preclude IPR

by | Jan 11, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s denial of a preliminary injunction seeking to bar a petitioner from challenging certain patents at the US Patent & Trademark Office (PTO) because of a forum selection clause in a settlement agreement. The Court found that the patent owner was unlikely to succeed on the merits based on the likelihood of success factor. DexCom, Inc. v. Abbott Diabetes Care, Inc., Case No. 23-1795 (Fed. Cir. Jan. 3, 2024) (Dyk, Hughes, Stoll, JJ.)

DexCom and Abbott are competing manufacturers of continuous glucose monitoring systems. In 2014, the parties entered into a settlement agreement that included a cross-license to certain patents, covenants not to sue or challenge the patents for a “Covenant Period,” and a forum selection clause identifying the US District Court for the District of Delaware as the exclusive jurisdiction “over any dispute arising from or under or relating to [the] Agreement, to the extent permitted by law.” After expiration of the Covenant Period, DexCom sued Abbott in the Western District of Texas. Abbott moved to transfer the case to the District of Delaware and added a breach of contract counterclaim, citing the settlement agreement’s forum selection clause. The case was transferred to Delaware, after which Abbott filed eight petitions for inter partes review (IPR) at the PTO. DexCom responded to the breach of contract counterclaim by alleging that Abbott had breached the forum selection clause by filing the IPR petitions. Until this point, DexCom had consistently taken the position that the asserted claims were not subject to the cross-license, rendering the forum selection clause inapplicable.

Six months after Abbott filed the IPR petitions, DexCom moved for a preliminary injunction prohibiting the IPRs from proceeding. The district court denied the preliminary injunction. In evaluating the four injunctive relief factors (i.e., likelihood of success on the merits, irreparable harm, balance of hardships and public interest), the district court simply assumed the likelihood of success in favor of DexCom. It nevertheless denied the injunction because DexCom waited six months to file the motion (suggesting there was no irreparable harm) and because DexCom had taken inconsistent legal positions with respect to whether the challenged patents were licensed, thus weighing against DexCom in the balance of hardships factor. DexCom sought interlocutory appeal of the district court’s order.

The Federal Circuit focused on the first factor, likelihood of success on the merits. While the district court assumed that this factor favored DexCom, the Federal Circuit disagreed. The Court noted that the agreement required that DexCom and Abbott “shall not Challenge” each other’s patents during the Covenant Period, with the exception that “each Party reserves its rights and is permitted to Challenge any of the patents of the other Party if there is a statute, regulation, or rule that sets a deadline to make the Challenge,” assuming certain conditions were met. The Court first explained that “challenge” includes IPRs of the patents and that nothing in the forum selection clause differentiated between the [...]

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Wave Goodbye: Arguments Incorporated by Reference Are Waived

by | Nov 30, 2023 |

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s patentability determination, finding that the patent challenger waived an argument it attempted to incorporate by reference to another brief. Medtronic, Inc. v. Teleflex Life Scis. Ltd., Case No. 2022-1721 (Fed. Cir. Nov. 16, 2023) (Lourie, Prost, Chen, JJ.)

Teleflex owns a patent directed to a method for using a guide extension catheter with a guide catheter. Medtronic challenged the patent in two inter partes review (IPR) proceedings, arguing that certain claims were obvious in light of Ressemann and Itou and that another claim was obvious in light of Ressemann, Itou and Kataishi. Teleflex argued that Itou was not prior art because the claimed invention was conceived prior to Itou’s filing date and was either actually reduced to practice before the critical date or diligently pursued until its constructive reduction to practice date. Medtronic did not contest Teleflex’s demonstration of conception but instead challenged Teleflex’s alleged showings of both actual reduction to practice and diligence until constructive reduction to practice.

The Board ultimately found that Itou did not qualify as prior art and that Medtronic therefore had not shown that the challenged claims were unpatentable. One of the issues before the Board was whether in vivo testing was required for actual reduction to practice because the claims at issue were method claims reciting “advancing . . . a guide catheter . . . through a main blood vessel to an ostium of a coronary artery.” The Board ultimately found that no such testing was required, explaining that Medtronic “was unable to identify any legal precedent requiring in vivo performance of a claimed in vivo method to show actual reduction to practice.” According to the Board, actual reduction to practice could “be verified using a physical model that replicates the anatomy in which the method would likewise be performed in vivo.” Medtronic appealed.

Medtronic challenged the Board’s determination regarding constructive reduction to practice, arguing as follows:

In addressing diligence, the Board simply adopted its earlier erroneous diligence analysis in IPR2020-00132. Appx61–62. Therefore, if this Court vacates the Board’s diligence holding in No. 21-2356, it should likewise vacate the Board’s decision here. Appellant’s Br. at 41.

The Federal Circuit explained that it did not vacate the diligence holding in the prior decision, so Medtronic’s condition precedent had not been met. Medtronic nevertheless urged the Court to decide the diligence question. The Court refused, finding that Medtronic improperly incorporated by reference an argument from another brief. The Court explained that it would be fundamentally unfair to allow Medtronic to use incorporation by reference to exceed the word limit on briefs. The Court observed that parties pursuing appeals must make certain strategic decisions concerning what material to include in their opening briefs, and here, Medtronic affirmatively chose not to include developed arguments on diligence. The Court therefore found that Medtronic waived its challenge to the Board’s diligence finding. With the diligence issue waived and conception stipulated, the Court affirmed [...]

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Distinguishing Drinkware—Provisional Priority Determined Differently in Pre- and Post-AIA Patents

by | Nov 30, 2023 | ,

In a precedential final written decision, the Patent Trial & Appeal Board concluded that a patent does not need to contain a claim supported by a provisional application’s disclosure to draw priority to that provisional for prior art purposes post America Invents Act (AIA). Penumbra, Inc. v. RapidPulse, Inc., IPR2021-01466, paper 34 (PTAB Mar. 10, 2023) (designated precedential Nov. 15, 2023) (Melvin, Cotta, Wisz, APJs).

Penumbra filed an inter partes review (IPR) petition targeting a patent directed to a “thrombectomy system,” which is a system for removing blood clots in the brain. Penumbra challenged the claims on four different grounds, and each included the Tiegen reference. Therefore, the petition would fail if the Tiegen reference was not prior art.

The challenged patent was filed on July 18, 2019, and drew priority to a provisional application filed on October 24, 2018. Tiegen drew priority to two provisional applications—one dated December 12, 2018, and another dated July 24, 2018. Whether Tiegen was prior art thus depended on whether the challenged patent could draw priority to its provisional application, and whether Tiegen could draw priority to its July 24, 2018, provisional. RapidPulse challenged Tiegen on both bases.

First, the Board assessed the proper priority date for the challenged patent. The Board explained that in order for the patent to draw priority to its provisional application, that provisional application had to provide written support for the challenged patent’s claims. Penumbra argued that the challenged patent’s provisional application did not have written support for the claimed “prevent[ing] forward flow.” RapidPulse responded, arguing that the disclosure of a “minimal amount of momentum from the fluid column” disclosed the claimed “preventing forward flow.” Forward flow generates momentum from the fluid column, so minimizing momentum required preventing fluid flow, according to RapidPulse. RapidPulse also pointed to embodiments that had substantially no forward flow from the distal end of the system.

Penumbra responded by explaining that the provisional application required forward flow in some embodiments, and nothing in the specification stated that the flow should be prevented. The Board agreed, explaining that the provisional application included embodiments with forward flow, and while the provisional recited some embodiments with small amounts of forward flow, the provisional did not indicate that the low forward flow was significant. The Board observed that “one cannot disclose a forest in the original application, and then later pick a tree out of the forest.”

Having determined that the priority date of the challenged patent was July 18, 2019, the Board turned to the priority date of Tiegen. The Board distinguished the present case over Dynamic Drinkware, a 2015 US Court of Appeals for the Federal Circuit case. Dynamic Drinkware states that for prior art purposes, a prior art patent can only draw priority to a provisional application if the prior art patent contains a claim supported by that provisional application. The Board explained that Dynamic Drinkware does not apply post-AIA. Instead, the Board found that, based on the language of AIA 35 [...]

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See Here: No Standing Based on Vague Future Plans or Adverse Priority Findings

by | Nov 16, 2023 |

The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact. Allgenesis Biotherapeutics Inc. v. Cloudbreak Therapeutics, LLC, Case No. 22-1706 (Fed. Cir. Nov. 7, 2023) (Moore, Stoll, Cunningham, JJ.)

Allgenesis Biotherapeutics filed an IPR petition challenging a patent owned by Cloudbreak Therapeutics. The challenged patent discloses compositions and methods for treating the eye condition pterygium. During the IPR proceeding, Cloudbreak disclaimed all but two of the claims. The Patent Trial & Appeal Board issued a final written decision finding that Allgenesis failed to show that the remaining two claims were unpatentable. As part of its decision, the Board made a priority decision that a Patent Cooperation Treaty (PCT) application belonging to Allgenesis was not prior art to Cloudbreak’s patent. Allgenesis appealed.

Article III of the US Constitution limits the Federal Circuit’s jurisdiction to adjudication of “cases” or “controversies,” which means the appellant must have (1) suffered an injury in fact (2) that is fairly traceable to the challenged conduct of the defendant and (3) likely to be redressed by a favorable judicial decision.

Allgenesis attempted to establish Article III standing based on two separate arguments. First, Allgenesis argued that it had standing based on potential infringement liability. To support that argument, Allgenesis offered a declaration by its vice president of finance that included information about a Phase II trial completed three years prior and a related 2020 publication. That declaration, however, did not identify any specific plan to conduct a Phase III trial or to seek US Food and Drug Administration (FDA) approval, and instead only contained generic statements that the project was not abandoned. While Allgenesis’s briefing and oral argument included statements that it planned to engage in a Phase III trial, the Federal Circuit determined that there was no record support for this claim. The Court found that the evidence before it did not constitute the necessary concrete plans to convey standing to appeal the final written decision. Allgenesis also attempted to rely on its own failed attempts at seeking a settlement from Cloudbreak, but the Court concluded that this was insufficient to show a substantial risk of infringement.

Allgenesis’s second argument was that the Board’s priority decision created an injury in fact. Allgenesis argued that the Board’s determination about the priority date of Cloudbreak’s patent affected Allgenesis’s patent rights because it would have a preclusive effect on Allgenesis’s pending applications. The Federal Circuit was unpersuaded and explained that collateral estoppel does not attach to a non-appeal priority decision from an IPR decision. To the extent that an examiner did reach the same conclusion as the Board, Allgenesis would be free to appeal that decision.

Practice Note: For Board petitioners seeking to establish standing to appeal unfavorable final written decisions, it is necessary to develop sufficient support to show standing in fact. For life sciences companies working in drug development, declarations [...]

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Status Quo Has Few Defenders at PREVAIL Act Senate Subcommittee Hearing

by and | Nov 16, 2023 | ,

On November 8, 2023, the US Senate Judiciary Subcommittee on Intellectual Property heard testimony from four witnesses on the proposed Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act. Although the PREVAIL Act includes several provisions regarding transparency and independence, its thrust is its dramatic alteration of Patent Trial & Appeal Board post-grant review (PGR) and inter partes review (IPR) proceedings, including their relationship to co-pending district court litigation, with the goal of incentivizing innovation by reducing costs and making such challenges less likely to be successful.

We previously reported on the provisions of the proposed PREVAIL Act when it was introduced. The biggest changes under consideration include the introduction of a standing requirement, a heightened burden of proof from preponderance-of-the-evidence to clear-and-convincing evidence, a stronger estoppel to thwart costly and unnecessary co-pending actions in court and at the Board, and the separation of the Board’s institution and decision-making functions.

Three witnesses spoke in favor of the PREVAIL Act before the subcommittee, emphasizing that the Board failed to live up to the purposes and intentions of the America Invents Act (AIA). These witnesses were Representative Lamar Smith, a co-sponsor of the AIA; Michelle Armond, co-founder of the law firm Armond Wilson LLP and a practitioner before the Board; and Joseph Kiani, founder of Masimo Industries.

Smith testified that Congress enacted the AIA because it recognized the potential for Board proceedings to be abused, and according to Smith, that is exactly what has happened. Each of the three witnesses testified that well-funded litigants have exploited Board procedures to overwhelm small businesses by forcing them into expensive duplicative proceedings in multiple forums. For example, Kiani posited that the Board posed an existential threat to startups, attributing findings of invalidity against his company’s patents to the AIA’s invalidation-friendly procedures.

Armond explained to the subcommittee how the PREVAIL Act would streamline Board proceedings and harmonize them with district court and International Trade Commission (ITC) litigation. According to Armond, in the wake of the AIA, both the Board and district courts have failed to offer uniform standards for deciding whether to stay a proceeding in their forum pending resolution of a parallel proceeding in the other. The PREVAIL Act would resolve this problem by requiring litigants to select only one forum in which they may raise their invalidity arguments. Armond argued that using the same clear-and-convincing-evidence standard in Board review proceedings and other litigation would harmonize the Board with district courts and the ITC by ensuring that different forums reach the same invalidity decision.

Joseph Matal, former US Patent & Trademark Office interim director and acting solicitor, and current principal of Clear IP, LLC, was the lone dissenting witness at the hearing. According to Matal, the PREVAIL Act’s proposal to require a clear-and-convincing-evidence standard in Board review proceedings is misguided because Board judges possess the requisite agency expertise to second-guess patent examination decisions. Additionally, Board judges often have more time to evaluate the patents and more information than the examiner. According to Matal, [...]

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Say Goodbye: Argument Not Presented in IPR Petition Is Waived

by | Nov 2, 2023 |

In a split decision, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board patentability determination, finding that the challenger’s appeal arguments were not raised in its inter partes review (IPR) petitions and were therefore waived. Netflix, Inc. v. DivX, LLC, Case Nos. 22-1203; -1204 (Fed. Cir. Oct. 25, 2023) (Linn, Chen, JJ.) (Dyk, J., dissenting).

DivX owns two patents directed to media streaming technologies. In media streaming, content (such as a movie) is typically stored as separate “streams” suitable for different device capabilities. A playback device must be able to select the appropriate media file from the available streams. To accomplish this selection, the challenged patents discuss a method for automatically generating top-level index files that describe the location and content of container files having streams of media. In particular, an independent claim in each of the patents recites a method comprising “receiving” a request for content, “retrieving” a list of assets associated with the content, “filtering” the list of assets using device capability, “generating . . . a top level index file describing each asset in the filtered list of assets” and “sending the top level index file” to the playback device.

Netflix challenged the two patents in two separate IPR proceedings based on two combinations of prior art references: Pyle and Marusi, and Lewis and Marusi. The Board issued lengthy final written decisions for both petitions, closely analyzing the arguments and evidence presented by Netflix and DivX. The Board determined that Netflix failed to meet its burden of showing that the challenged claims were unpatentable. Netflix appealed.

At the outset, the Federal Circuit noted that “Netflix’s appeal does not challenge any of the Board’s substantive analysis.” It instead makes a purely procedural argument, accusing the Board of “falling down on the job by failing to address several arguments purportedly raised in Netflix’s petitions.” One such argument that the Court identified related to the “filtering” claim element. The Court, the Board and Netflix all agreed that Netflix had advanced an argument that Pyle teaches the filtering element based on Pyle’s selection of a preexisting manifest. Netflix, however, argued on appeal that it also had advanced an argument that Pyle teaches the filtering element based on Pyle’s creation of a new manifest. The Board found that this argument was not presented in Netflix’s petition, and the Federal Circuit agreed. At the Federal Circuit, Netflix identified various block quotes in its petition that purported to support the argument. However, the Court found that “nothing in the quoted language itself signals to a reader that an optimized new manifest equates to ‘filtering the list of assets.’” Furthermore, “the petition made it quite clear Netflix was focused on Pyle’s pre-existing manifest . . . Netflix thus showed it knew how to put forward a clear mapping of Pyle to the filtering limitation, but never connected Pyle’s new manifest to that limitation.”

Judge Dyk dissented. In his opinion, Netflix had not failed to advance the “new manifest” [...]

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Go With the Flow: “A” Still Means “One or More”

by | Oct 26, 2023 |

The US Court of Appeals for the Federal Circuit reversed a claim construction that was adopted during an inter partes review (IPR) because the Patent Trial & Appeal Board erred in construing the contested limitation as limited to a single sample rather than including the possibility of plural samples. ABS Global, Inc. v. Cytonome/ST, LLC, Case No. 22-1761 (Fed. Cir. Oct. 19, 2023) (Reyna, Taranto, Stark, JJ.)

ABS and Genus plc (collectively, ABS) filed a petition to institute an IPR on a patent owned by Cytonome. The patent claims microfluidic devices for particle (e.g., cells, molecules and other particles of interest) processing. The claimed devices exploit the principles of laminar flow to hydrodynamically focus particles at a certain point along the flow path for inspection or other purposes. The claimed devices are capable of hydrodynamically focusing the flow of a particle-containing fluid (the sample fluid) by abutting the sample fluid on more than one side with a fluid that does not contain particles (the sheath fluid). Generally, the faster the sheath fluid flows relative to the sample fluid the more the sample fluid’s corresponding cross-section is compressed. Figure 3A of the patent is an example of how the claimed devices use sheath fluid (SF) to focus a sample fluid (S) along a channel (CL):

ABS’s petition argued that the challenged claims were anticipated or obvious at least in view of a prior publication that taught devices with a split sample stream. The Board disagreed, construing the challenged patent claims as directed to a single sample stream and concluding that ABS failed to demonstrate why those of ordinary skill—in view of the art cited in ABS’s petition—would have modified the prior art split sample stream into the claimed single sample stream. ABS appealed.

The Federal Circuit found that the Board erred in construing the challenged claims. In construing the independent claim as being limited to a single sample stream, the Board focused on two limitations: “an inlet configured to receive a sample stream” and “a fluid focusing region configured to focus the sample stream….” In limiting the claim to a single sample stream, the Board relied on the definite article preceding the second recitation of “sample stream” and noted that a plural-allowing interpretation would be inconsistent with a dependent claim that further requires the focusing fluid to be “introduced into the flow channel symmetrically with respect to a centerline of the sample stream.”

The Federal Circuit reversed the Board’s claim construction, concluding that the dependent claim was not inconsistent with a plural-streams interpretation for the independent claim and that the Board committed two errors in construing both claims. First, the Board did not properly apply what the Court refers to as the “general rule,” which is applicable to open-ended “comprising” claims that recite “a” or “an” before a noun. The Court explained that such a limitation should be construed to mean one or more unless context sufficiently indicates otherwise. Second, [...]

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