obviousness Archives

obviousness

Motivation MIA? Federal Circuit Sends IPR Back to the Drawing Board

by Keval Amin | Jan 9, 2025 | Patents

The US Court of Appeals for the Federal Circuit vacated and remanded a Patent Trial & Appeal Board decision, finding that the Board erred by failing to explain its holding and reasoning regarding a motivation to combine prior art references. Palo Alto Networks, Inc. v. Centripetal Networks, LLC, Case No. 23-1636 (Fed. Cir. Dec. 16, 2024) (Stoll, Dyk, Stark, JJ.)

Centripetal Networks owns a patent directed to correlating packets in communications networks, introducing an innovative system designed to enhance network security. The patent focuses on packets (small data segments that collectively form larger communications) and their correlation across network boundaries.

Palo Alto Networks challenged the patent’s validity in an inter partes review (IPR) and argued its obviousness based on three prior art references. The first reference described a system using hashing techniques to identify packets traversing network address translation boundaries and teaching how to correlate packets across such boundaries to identify hosts transmitting or receiving them. The second reference detailed methods for detecting unauthorized traffic directed to unused IP addresses, notifying administrators of potential threats, and enabling automated responses, such as blocking or filtering malicious traffic. The reference taught notifying administrators how to manage packets involved in malicious activity after they crossed a network boundary.

Palo Alto argued that combining the packet correlation techniques of the first reference with the notification mechanisms of the second addressed a key claim limitation of the challenged patent. Palo Alto contended that transmitting an indication of a malicious host, as taught by the second reference, naturally followed from the correlation system described in the first. However, the Board found that Palo Alto failed to provide sufficient evidence or argument to show that a person of ordinary skill in the art (POSITA) would recognize the claimed responsiveness between the first reference’s packet correlation and the second reference’s notification mechanisms. Palo Alto appealed.

The Federal Circuit vacated and remanded the Board’s decision, finding that the Board erred by failing to clearly articulate its rationale regarding the motivation to combine the prior art references and whether their combination satisfied the critical limitation of the challenged patent claim. The Court emphasized that the proper inquiry in an obviousness analysis is not whether each reference individually discloses all claim elements but whether their combination would have rendered the invention obvious to a POSITA.

Palo Alto maintained that the Board did not dispute the existence of a motivation to combine and improperly searched for a “bridge” solely within the two references. Centripetal countered that Palo Alto had not established a motivation or provided evidence of a necessary connection – or “bridge” – between the prior art and the claimed invention.

The Federal Circuit determined that the Board’s decision lacked a definitive finding on whether a POSITA would have been motivated to combine the first reference’s correlation techniques with the second reference’s notification step. The Court noted that Palo Alto presented logical and evidentiary support as to why such a combination would make sense, arguing that without a notification step, the [...]

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Chromatographic Clash: When Is a Lead Compound Analysis Even Necessary?

by Hannah Hurley | Dec 12, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s determination that 79 challenged composition claims across three related patents were unpatentable but reversed the Board’s determination that four challenged process claims were not unpatentable. Cytiva Bioprocess R&D v. JSR Corp., et al., Case Nos. 23-2074; -2075; -2191; -2192; -2193; -2194; -2239; -2252; -2253; -2255 (Fed. Cir. Dec. 4, 2024) (Prost, Taranto, Hughes, JJ.)

The patents in question pertain to chromatography matrices used in affinity chromatography for isolating antibodies. Their primary focus was on the G29A mutation in SPA IgG binding domains, which enhances stability in alkaline environments. The Board upheld the patentability of the process claims while invalidating the composition claims. Cytiva appealed, arguing that the Board erred in its lead compound analysis. JSR cross-appealed on the Board’s finding that the challenged process claim were not unpatentable.

The Federal Circuit disagreed with Cytiva’s argument that a lead compound analysis was necessary. A lead compound analysis is an obviousness framework that involves a two-part inquiry: whether a skilled person in the art would have selected the compound as a starting point for research, and whether the prior art would have motivated the skilled person to modify the compound into the claimed invention. The Federal Circuit noted that lead compound analyses are not always required in chemical patent cases where the prior art references expressly suggest the proposed modification, which was the case here. The Court also explained that even though a lead compound analysis was used here, in this case the claimed compounds could all be lead compounds, and the prior art expressly suggested the G29A modification of the claimed compound.

The Federal Circuit also addressed whether a claim limitation that merely recites an inherent property of an otherwise obvious combination requires additional analysis to demonstrate that a person of ordinary skill in the art would have a reasonable expectation of success. The Court found that additional analysis was unnecessary because “the sole disputed limitation was an inherent property of the claimed composition already determined to be obvious.” The Court found that the Fab binding property of the chromatography matrices was inherent and thus did not require a separate reasonable expectation of success analysis.

As for the process claims that the Board found not unpatentable, the Federal Circuit determined that the composition and process claims were “nearly identical and contain[ed] no substantive distinction relevant to th[e] appeal.” Therefore, the Court held that the Board erred in separating the composition and process claims and found “no basis for treating the claims differently.” The Federal Circuit reversed the Board’s “not unpatentable” determination on those claims and held all challenged patent claims obvious and therefore unpatentable.

Plausible Alternative Understanding of Prior Art? So What?

by Connor M. Larson | Dec 12, 2024 | Patents

Affirming the Patent Trial & Appeal Board’s final determination that three claims were invalid for obviousness, the US Court of Appeals for the Federal Circuit ruled that a “plausible alternative understanding” of the prior art did not compel a reversal under the substantial evidence review standard. Koninklijke KPN N.V. v. Vidal, Case No. 19-2447 (Fed. Cir. Dec. 2, 2024) (Prost, Reyna, Chen, JJ.)

Three computer networking companies filed a petition for inter partes review (IPR) to challenge the patentability of claims of a patent for regulating access to a telecommunications network owned by Koninklijke. The challenged claims included limitations concerning devices, identified by a controller with a unique identifier, that requested access to a network. The controller allowed each device network access based on a “grant access time interval.” The petitioners argued that the challenged claims were unpatentable as obvious in view of three prior art references: Obhan, Shatzkamer, and Budka.

After considering the parties’ argument over what was disclosed by the references, the Board found that Obhan disclosed an admission control system for a wireless network that included assigning devices a “good till time.” The Board found that Shatzkamer disclosed managing a wireless network using a system to identify specific devices, add those devices to a “blacklist,” and deny network access to the blacklisted devices. The Board determined that the combination of Obhan, Shatzkamer, and Budka taught the limitations of the challenged claims. Koninklijke appealed.

Koninklijke argued that the Board erred in its determination that the prior art references taught certain claim limitations and provided motivation to combine the references.

Koninklijke first argued that substantial evidence did not support the Board’s finding that Obhan disclosed the access request limitations of the challenged claims. Koninklijke also argued that Obhan did not teach consulting a “good till time” to determine whether to allow a device to access the network. The Federal Circuit disagreed, finding that Koninklijke’s argument merely presented “a plausible alternative understanding of Obhan.” The Court explained that under the substantial evidence standard of review, this was not enough to conclude that the Board’s decision was unsupported by substantial evidence. The Court declined to reweigh the evidence or make factual findings of its own.

Second, Koninklijke argued that the Board’s determination was not supported by substantial evidence because the Board misread and misstated one of the challenged claims. An exemplary claim of the challenged patents recited “an access operation to deny access for the terminal if the access request is received within the time period,” whereas another recited “denying the terminal access to the telecommunications network responsive to the access request being received within the time period defined by the accessed identification of at least one associated deny access time interval.” In its decision, the Board stated that second claim “requires only that the access request be denied if it is received within the time period during which access is denied.” Koninklijke faulted the Board for using the term “if” instead of “responsive to.”

The Federal Circuit did not find [...]

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Unified Front: No Forfeiture by Failing to Raise Argument in Request for Rehearing

by Courtney Seams | Aug 8, 2024 | Patents

Addressing forfeiture of issues on appeal and sufficiency of the asserted prior art, the US Court of Appeals for the Federal Circuit upheld a Patent Trial & Appeal Board obviousness finding, explaining that a party does not waive arguments on appeal by failing to include them in a request for rehearing. Voice Tech Corp. v. Unified Patents, LLC, Case No. 22-2163 (Fed. Cir. Aug. 1, 2024) (Lourie, Chen, Cunningham, JJ.)

Unified Patents petitioned for inter partes review (IPR) of a Voice Tech patent that purported to improve upon the prior art by allowing a single mobile device to access and control various native applications and functions on a computer. Unified alleged that the challenged claims were unpatentable as obvious over three prior art references. The Board agreed and found that all of the challenged claims were unpatentable. Voice Tech appealed.

Voice Tech argued that Unified’s petition failed to identify any disclosure in the prior art that taught the “mobile device interface” claim limitation in the challenged claims because Unified’s claim analysis failed to expressly mention a “mobile device interface.” The Board dismissed this argument, finding that Unified properly mapped its analysis of other patent claims to the “mobile device interface” claim recitation and presented a sufficient argument regarding obviousness. The Federal Circuit agreed that one of the prior art references taught a “mobile device interface.” The Court found that the Board did not rely on a new theory not found in the IPR petition, but instead had mapped the “mobile device interface” limitations to the prior art because the petition itself raised the theory.

Voice Tech also argued that the Board had failed to properly interpret certain claim terms. Unified countered that Voice Tech forfeited the claim construction arguments because they were not included in Voice Tech’s request for rehearing to the Board. The Federal Circuit disagreed, finding that a party’s choice to not re-raise an argument in a request for rehearing will not, by itself, forfeit the argument for review on appeal. The Court found that since Voice Tech had raised the claim construction arguments to the Board in its patent owner’s response, it had not forfeited those arguments on appeal.

The Federal Circuit also addressed Unified’s argument that Voice Tech’s proposed claim constructions would not change the outcome of the patentability analysis given the Board’s findings that the prior art disclosed the claim terms. The Court agreed with Unified, finding that it only needed to construe claim terms as necessary to resolve the controversy. The Court found that because Voice Tech’s responsive arguments were conclusory and failed to address how Voice Tech would be prejudiced by the Board’s adopted claim construction, the Federal Circuit did not need to consider Voice Tech’s claim construction arguments.

Finally, the Federal Circuit addressed Voice Tech’s arguments that the Board erred in finding that the prior art taught certain claim limitations and that Unified’s obviousness analysis was based on hindsight bias. The Court upheld the Board’s obviousness determinations as to all challenged claims, [...]

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PTAB MTA Pilot Program to the Rescue

by Thomas DaMario | Aug 1, 2024 | Patents

On review of a final written decision from the Patent Trial & Appeal Board in an inter partes review (IPR), the US Court of Appeals for the Federal Circuit found that all challenged claims were obvious but left open the possibility of the patent owner amending the claims under the Motion to Amend (MTA) Pilot Program. ZyXEL Communications Corp. v. UNM Rainforest Innovations, Case Nos. 22-2220; -2250 (Fed. Cir. July 22, 2024) (Dyk, Prost, Stark, JJ.)

ZyXEL Communications petitioned for IPR challenging claims 1 – 4, 6, 7 and 8 of a patent owned by UNM Rainforest Innovation (UNMRI). The patent relates to methods for constructing frame structures in communication systems using orthogonal frequency-division multiple access (OFDMA) technologies. The patent describes a method for constructing a frame structure with two sections, each of which is configured for a different communication system, where the second communication system is used to support high mobility users (i.e., faster moving users).

Before the Board, ZyXEL argued that claims 1 – 4, 6 and 7 were unpatentable in light of two prior art references (Talukdar and Li), and that claim 8 was unpatentable in light of Talukdar and another prior art reference (Nystrom). During the Board proceedings, UNMRI filed a contingent motion to amend if any of the challenged claims were found to be unpatentable. As part of its motion, UNMRI requested preliminary guidance from the Board pursuant to the Board’s MTA Pilot Program. In its opposition to UNMRI’s motion to amend, ZyXEL argued that UNMRI’s amended claims lacked written description support, and in its preliminary guidance, the Board agreed. UNMRI attempted to file a revised motion to amend, but the Board rejected the revised motion and instead permitted UNMRI to file a reply in support of its original motion. It also allowed ZyXEL to file a sur-reply. The Board determined that claims 1 – 4, 6 and 7 were unpatentable, but that claim 8 was not. The Board also granted UNMRI’s motion to amend and determined that the new claims were nonobvious over the prior art of record. Both sides appealed.

With respect to the Board’s decision on the obviousness of claims 1 – 4, 6 and 7, the Federal Circuit found that substantial evidence supported the ruling. UNMRI’s primary argument was that a person of skill in the art (POSA) would not have been motivated to combine Talukdar and Li, but the Court credited the Board’s reliance on ZyXEL’s expert, who demonstrated sufficient motivation to combine the two references.

The Federal Circuit reversed the Board’s finding that claim 8 had not been shown to be obvious, however. The Court noted that while the Nystrom reference may not explicitly state the benefit of the missing limitations, “a prior art reference does not need to explicitly articulate or express why its teachings are beneficial so long as its teachings are beneficial and a POSA would recognize that their application was beneficial.”

Regarding UNMRI’s motion to amend, ZyXEL argued that the Board erred in granting the [...]

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Say What? Recitation Entitled to Patentable Weight When Not “Communicative Content”

by Connor M. Larson | May 16, 2024 | Patents

Addressing when claimed printed matter is entitled to patentable weight, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s ruling involving the printed matter doctrine, explaining that the claimed subject matter was not communicative content. IOEngine, LLC v. Ingenico Inc., Case No. 21-1227 (Fed. Cir. May 3, 2024) (Lourie, Chen, Stoll, JJ.)

Financial technology company Ingenico filed three petitions for inter partes review (IPR) of certain claims from three patents owned by IOEngine, all of which shared the same title and written description. The patents, titled “Apparatus, Method and System for a Tunneling Client Access Point,” claimed a “portable device” that was “configured to communicate with a terminal.” The challenged claims recited a memory that contained program code “configured in various ways to facilitate communication … with a communications network node.”

The Board issued final written decisions, which found the challenged claims to be unpatentable for obviousness or anticipation. The Board also found several claims to be anticipated after giving no patentable weight to certain claim recitations by application of the printed matter doctrine. The Board found that the terms “encrypted communications” and “program code” claim “only communicative content” (i.e., printed matter) and that these recitations were not entitled to patentable weight.

The Board concluded that the recitation of “encrypted communications” was subject to the printed matter doctrine because “nothing in the claim … requires anything beyond sending and receiving data, even if the data is in an encrypted form.” Similarly, the Board found that the recitation “program code” was subject to the printed matter doctrine because the “recital of ‘downloading’ of program code was limited to downloading (sending or transmitting) the code, which is a communication, and no other function is recited in the claim.”

IOEngine appealed, arguing that the Board erroneously construed the term “interactive user interface,” erred in its application of the printed matter doctrine, and erred in its anticipation and obviousness analysis.

The Federal Circuit affirmed the Board’s claim construction, finding IOEngine had forfeited its proposed construction because it did not present it to the Board during the IPR proceeding. Likewise, the Court affirmed the Board’s unpatentability determination of anticipation and obviousness for those claims where the Board did not invoke the printed matter doctrine.

However, the Federal Circuit reversed the Board’s determination that the recitations “encrypted communications” and “program code” were entitled to no weight under the printed matter doctrine.

The Federal Circuit explained that courts use a two-step test to determine whether a recitation should be accorded patentable weight under the printed matter doctrine. First, a court should determine “whether the limitation in question is directed toward printed matter.” Under step one, a limitation should be considered printed matter when the limitation “claims the content of information,” meaning that “the matter [is] claimed for what it communicates.” Only if the first step is met should the court proceed to step two. In the second step, the court considers “whether the printed matter nevertheless should be given patentable [...]

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Unclean Hands Aren’t Just for Toddlers

by Jacob Michael Bass | Apr 25, 2024 | Patents

In an action involving manufacturers of a self-sealing dining mat for toddlers, the US Court of Appeals for the Federal Circuit affirmed a district court’s finding that the defendants were barred from obtaining relief on their counterclaims under the unclean hands doctrine, thereby vacating the district court’s other findings on inequitable conduct, obviousness, attorneys’ fees and costs. Luv N’ Care, Ltd. et al. v. Laurain et al., Case No. 22-1905 (Fed. Cir. Apr. 12, 2024) (Reyna, Hughes, Stark, JJ.)

Luv N’ Care and Nouri E. Hakim (collectively, LNC) filed suit against Lindsey Laurain and Eazy-PZ (EZPZ), asserting various claims for unfair competition under the Lanham Act and Louisiana law. LNC also sought declaratory judgment that EZPZ’s design patent was invalid, unenforceable and not infringed. After the suit was filed, the US Patent & Trademark Office (PTO) issued Laurain a utility patent directed toward self-sealing dining mats. Laurain subsequently assigned her rights to EZPZ, which then asserted counterclaims for utility patent, design patent and trademark infringement.

Following discovery, the district court granted LNC’s motion for summary judgment, finding all claims of EZPZ’s utility patent as obvious in view of three prior art references. EZPZ moved for reconsideration, which the district court denied, indicating that a “ruling providing further reasoning will follow in due course.” Before any such ruling issued, the PTO issued an ex parte reexamination certificate confirming the patentability of the utility patent claims two days before the district court’s bench trial began.

EZPZ did not provide this reexam certificate to the district court prior to the bench trial. During the bench trial, the district court found that EZPZ had not committed inequitable conduct but that EZPZ’s litigation conduct constituted unclean hands. After the district court entered judgment, EZPZ moved for reconsideration of summary judgment based on the ex parte reexamination certificate. The district court denied this motion and found that the evidence did not compel alteration of the prior ruling that the utility patent was invalid. It also denied LNC’s motion for attorneys’ fees and costs. EZPZ appealed.

The Federal Circuit affirmed the unclean hands determination but vacated the district court’s rulings on inequitable conduct, invalidity, attorneys’ fees and costs. As to unclean hands, the Court reasoned that EZPZ failed to disclose patent applications related to the utility patent until well after the close of discovery and dispositive motion practice. EZPZ also blocked LNC’s efforts to discover Laurain’s prior art searches by falsely claiming that she had conducted no such searches and that all responsive documents had been produced. It further found that EZPZ witnesses, including Laurain and EZPZ’s former outside counsel, repeatedly gave evasive testimony during depositions and at trial. The Court affirmed the district court’s determination that EZPZ’s misconduct bore an immediate and necessary connection to EZPZ’s claims for infringement because the undisclosed material was directly relevant to the development of LNC’s litigation strategy and undermined LNC’s ability to press its invalidity and unenforceability challenges. The Court found no clear error in the district court’s reasoning that [...]

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Faulty Jury Instruction Tampered With Tamper-Proof Trial

by Keval Amin | Apr 4, 2024 | Patents

The US Court of Appeals for the Federal Circuit affirmed in part, vacated in part and remanded a district court decision after concluding that a jury instruction on the objective indicia of nonobviousness that failed to specify all indicia on which evidence had been received constituted prejudicial legal error. Inline Plastics Corp. v. Lacerta Group, LLC, Case Nos. 22-1954; -2295 (Fed. Cir. Mar. 27, 2024) (Taranto, Chen, Hughes, JJ.)

Inline Plastics owns a patent family pertaining to containers with specific tamper-proof features and methods of producing these containers using thermoformed plastic. The invention is intended to deter unauthorized tampering with products in the containers. These tamper-proof features serve to prevent theft and product loss and maintain consumer confidence in product integrity.

Inline sued Lacerta Group for patent infringement over its tamper-proof technology. The district court made several significant pretrial rulings, including a claim construction order, and granted Inline’s motion for partial summary judgment of infringement on some of the asserted claims. During trial, Inline voluntarily withdrew certain claims, and the jury returned a verdict declaring all remaining claims (even those on which summary judgment had been granted) invalid and not infringed. After trial, Inline sought partial final judgment, which was granted, but also motioned for judgment as a matter of law and a new trial on invalidity. The district court denied Inline’s motions. Both Inline and Lacerta appealed.

Inline argued that it was entitled to judgment as a matter of law of no invalidity and that an error in the jury instructions requires a new trial on invalidity. Lacerta cross-appealed, challenging the denial of attorneys’ fees and the “without prejudice” dismissal of certain patent claims that Inline voluntarily dropped from its asserted-claims list near the end of trial.

The Federal Circuit rejected Inline’s argument for judgment as a matter of law of no invalidity but agreed with Inline that the jury instruction on the objective indicia of nonobviousness constituted prejudicial legal error. The Court determined that the jury could have reasonably found obviousness and rejected Inline’s three arguments against it. First, Inline argued deficiencies in Lacerta’s prior art references and expert testimony, but the Court found these arguments unpersuasive. Second, Inline challenged Lacerta’s evidence of motivation to combine references, but the Court found enough support to prove a motivation to combine. Third, Inline argued that Lacerta’s challenge failed because there was no rebuttal or opinion on objective-indicia evidence. The Court dismissed this argument, explaining that the absence of such testimony did not necessarily discredit the patentee’s evidence on nonobviousness. According to the Court, Inline failed to explain why the jury could not reasonably assign little weight to its objective-indicia evidence, which led the Court to reject Inline’s categorical argument based on the absence of expert testimony from Lacerta’s side.

However, the Federal Circuit agreed with Inline’s argument for a new trial on invalidity. The Court explained that jury instructions must be legally correct and sufficiently comprehensive to address disputed evidence. The Federal Circuit concluded that the district court’s objective-indicia instruction [...]

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Is Evidence of All Claimed Elements in Prior Art Enough? Not Without Motivation to Combine

by Sydney E. McDermott | Apr 4, 2024 | Patents

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board obviousness decision, finding that disclosure in the prior art of all recited claim elements across multiple references, without more, does not establish obviousness unless there is evidence of a motivation to combine. Virtek Vision Int’l ULC v. Assembly Guidance Systems, Inc., Case No. 22-1998 (Fed. Cir. Mar. 27, 2024) (Moore, C.J.; Hughes, Stark, JJ.)

Virtek holds a patent that discloses “an improved method for aligning a laser projector with respect to a work surface.” Lasers are used to “project a template image onto a work surface to direct manufacturing processes.” The patent discloses a two-step process that improves efficiency over the prior art.

Aligned Vision petitioned for inter partes review (IPR), challenging all of the patent’s claims. Aligned Vision asserted four combinations of prior art references over which it contended the claims were obvious. In its Final Written Decision, the Board found that some of the claims were unpatentable as obvious, but others were not.

The Board determined that certain claims, which depended from the independent claim, would have been obvious over two combinations of references: Keitler and Briggs, and Briggs and Bridges. In pertinent part, the independent claim recites “identifying a pattern of the reflective targets on the work surface in a three dimensional coordinate system.” Save for the 3D claim element, all the other claim elements were disclosed in Bridges and Keitler. The Board found that a skilled artisan would have been motivated to use the 3D coordinate system disclosed in Briggs instead of the angular direction systems in Keitler or Bridges. The Board reasoned that this combination would have been obvious to try because Briggs disclosed both 3D coordinates and angular directions.

With respect to the direct appeal, the Federal Circuit found that the Board erred as a matter of law regarding motivation to combine. “It does not suffice to meet the motivation to combine requirement to recognize that two alternative arrangements such as an angular direction system using a single camera and a 3D coordinate system using two cameras were both known in the art.” Rather, the patent challenger must show that a skilled artisan would swap the element in one reference for an element in another reference. “The mere fact that these possible arrangements existed in the prior art does not provide a reason that a skilled artisan would have substituted the one-camera angular direction system in Keitler and Bridges with the two-camera 3D coordinate system disclosed in Briggs.”

Here, the patent challenger presented no argument in the IPR petition regarding why a skilled artisan would make this substitution, other than that the two different coordinate systems were “known to be used.” Specifically, Briggs made no mention of any benefits the 3D system might provide over the angular system. Aligned Vision’s expert testified multiple times that he could not provide a reason to combine the references, and Aligned Vision presented no evidence that “there are a finite number of [...]

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Optimizing Obviousness: Routine Optimization Can Fill in Prior Art Gaps

by Alexander Piala, PhD | Mar 14, 2024 | Life Sciences, Patents

In an appeal from a Patent Trial & Appeal Board finding of invalidity, the US Court of Appeals for the Federal Circuit held that the result-effective variable doctrine can apply even when there is no overlap between a claimed range and a prior art range. The Court also held that before denying a motion to amend, the Board must address every element of proposed claims, and that a party cannot challenge the US Patent & Trademark Office (PTO) Director Review procedure if it cannot show prejudice. Pfizer Inc. v. Sanofi Pasteur, Inc., Case No. 19-1871 (Fed. Cir. Mar. 5, 2024), (Lourie, Bryson, Stark, JJ.)

Sanofi filed five inter partes review (IPR) petitions targeting a patent owned by Pfizer and directed to immunogenic glycoconjugates of Streptococcus antigens (i.e., combinations of sugar molecules found on the surface of Streptococcus bacteria capable of provoking an immune response). The challenged independent claim recited conjugates having a sugar from the 22F Streptococcus serotype and a molecular weight falling within a claimed range. Dependent claims further limited the independent claim by requiring combinations of specific sugars.

Sanofi challenged the claims based on a combination of two references: GSK-711 and Merck-086. GSK-711 described vaccines using sugars from 22F, and Merck-086 described immunogenic compositions using Streptococcus sugar conjugates. While neither reference disclosed the molecular weight of a 22F conjugate, the Board found that the molecular weight of a conjugate was a “result-effective variable” – i.e., a variable that affected the efficacy of the result – and thus it would have been obvious for a person of ordinary skill in the art (POSITA) to optimize the molecular weight of a 22F-based conjugate to achieve the claimed molecular weight range. The Board also found that the dependent claims would have been obvious, as GSK-711 disclosed the additionally claimed sugars. Pfizer filed a motion to amend to add new claims, but the Board denied the motion. Pfizer also requested Director Review of the Board’s decision, but the Director denied the request.

Pfizer appealed to the Federal Circuit alleging that the Board improperly applied the result-effective variable doctrine, that the Board improperly denied Pfizer’s request to amend the claims, and that the Director’s denial of review violated the Administrative Procedure Act (APA). The Federal Circuit affirmed the Board’s finding of invalidity, affirmed in part and remanded in part the issue of the proposed claim amendment, and finally held that any violation of the APA was harmless.

The Federal Circuit started with an analysis of the result-effective variable doctrine. Pfizer argued that the result-effective variable doctrine could not apply when there was no disclosure of an effective range in the prior art. Therefore, because neither GSK-711 nor Merck-086 disclosed an effective molecular weight range for a 22F conjugate, and because the relationship between molecular weight and efficacy was unpredictable, the independent claim was not obvious. The Court disagreed.

The Federal Circuit explained that, when there is a gap between the prior art and the claims, the relevant [...]

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