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PTO Stands by Patent Fee Increases

by | Apr 11, 2024 |

The US Patent & Trademark Office (PTO) issued a notice of rulemaking announcing proposed patent fee increases beginning next year. 89 Fed. Reg. 23226 (April 3, 2024). The proposed increases are generally consistent with the PTO’s May 2023 proposal.

The Notice states that the PTO needs the proposed fee adjustments to provide sufficient revenue to recover costs of patent operations in future years. To that end, the PTO proposes to set or adjust 455 patent fees, including 73 new fees. Complete information about the fee adjustments, including the Notice, is available on the PTO’s website.

The fee increases include higher amounts for routine fees necessary to obtain a patent, including filing, search, examination and issue fees. Excess claim fees will also increase to $200 for each claim over 20 and $600 for each independent claim over three. There will also be an escalating fee structure for terminal disclaimers, ranging from $200 if filed before the first office action to $1,400 if filed after the PTO grants the patent. The fees for filing requests for continued examination (RCE) will now use a tiered fee structure and will increase to $1,500 for the first RCE, $2,500 for the second RCE and $3,600 for the third RCE. Patent Trial & Appeal Board fees will increase by about 25%, and a new fee of $400 will be required for a Request for Director Review of a Board decision.

Written comments on proposed patent fees must be submitted by June 3, 2024, through the Federal eRulemaking Portal.



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Faulty Jury Instruction Tampered With Tamper-Proof Trial

by | Apr 4, 2024 |

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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Who Solved the Problem? Joint Inventors, That’s Who

by | Apr 4, 2024 |

The US Court of Appeals for the Federal Circuit affirmed a district court’s decision to correct inventorship in a post-issuance inventorship dispute, finding that the alleged joint inventors’ contributions were significant even though they were mostly unclaimed. Tube-Mac Indus., Inc. v. Campbell, Case No. 22-2170 (Fed. Cir. Mar. 15, 2024) (Lourie, Hughes, Stark, JJ.) (nonprecedential).

Steve Campbell was the original sole inventor named on a utility patent application directed to a container for transporting gaseous fluids. Before Campbell filed the patent application, Campbell’s prototypes had a “major problem” with the container’s liner. Campbell enlisted the help of Tube-Mac Industries’ Gary Mackay and Dan Hewson to solve the problem. Campbell, Mackay and Hewson exchanged plans regarding the problem over the course of several months. Campbell’s patent issued, naming himself as the sole inventor. Mackay, Hewson and Tube-Mac filed suit seeking to be named as co-inventors. The district court agreed and ordered correction of the patent under 35 U.S.C. § 256. Campbell appealed.

A court may order a correction of inventorship when it determines that an inventor has been erroneously omitted from a patent. In any inventorship challenge, the inventors listed in an issued patent are presumed to be the correct inventor(s). Thus, a party challenging inventorship must prove incorrect inventorship by clear and convincing evidence. A joint inventor must contribute significantly to the invention’s conception or reduction to practice when that contribution is measured against the scope of the full invention.

The Federal Circuit found that prior to the involvement of Mackay and Hewson, Campbell did not have a viable invention that could be reduced to practice without extensive experimentation. The Court also found that Mackay’s and Hewson’s contributions solved the problem that precluded the prototype from being successful, even though their contributions were “mostly unclaimed.” The Court noted, however, that their contributions were included in the application’s figures, specifications and dependent claims. Accordingly, the Court found that Mackay and Hewson contributed significantly to the conception of the invention and should be included as co-inventors.

The Federal Circuit also dismissed Campbell’s arguments that the district court did not properly construe the claims to determine their scope and erred by misidentifying the subject matter of the claims.



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What Use Does § 271(e)(1) Safe Harbor “Solely” Protect?

by | Apr 4, 2024 |

The US Court of Appeals for the Federal Circuit affirmed that the 35 U.S.C. § 271(e)(1) safe harbor protecting certain infringing acts undertaken for regulatory approval applied to an alleged infringer’s importation of transcatheter heart systems while attending a trade conference, finding the importation reasonably related to submitting information to the US Food & Drug Administration (FDA) for medical device approval. Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., Case No. 22-1877 (Fed. Cir. Mar. 25, 2024) (Stoll, Cunningham, JJ.) (Lourie, J., dissenting).

The fact pattern in this case is unusual. Meril, a manufacturer of a transcatheter heart system approved for sale in Europe but not in the United States, brought two demonstration samples to San Francisco with lawyer-generated instructions that the samples could not be used, sold or offered for sale in the US. Meril presented at a trade booth during a cardiovascular medical device conference. It was undisputed that the samples never left a bag that was first kept at a hotel and later brought to the conference and placed in a storage room.

Edwards Lifesciences nevertheless sued for infringement based on importation. The district court found that Meril’s importation was reasonably related to its attempts to secure regulatory approval because they were for the purposes of recruiting investigators for a clinical trial Meril had made initial efforts to commence (as required to market this type of device in the US). Accordingly, the district court granted summary judgment of noninfringement on grounds that the safe harbor under § 271(e)(1) applied. Edwards appealed.

Edwards argued that the district court erred by not finding a genuine material dispute of fact relating to Meril’s subjective intent (i.e., whether, notwithstanding some evidence, Meril actually intended the importation to relate to FDA approval). Edwards also challenged whether the importation was solely related to FDA approval and argued that the non-use of the devices to recruit investigators rendered the safe harbor inapplicable.

The Federal Circuit rejected all three challenges. Canvassing the Federal Circuit’s decades of prior case law, the Court concluded that a putative infringer’s intent is irrelevant when determining whether the safe harbor applies. Thus, even if Edwards were correct in challenging Meril’s intent, there would still be no material factual dispute. On the issue of whether the importation activity was solely related to FDA approval, the Court, discussing the use of “solely” in terms of the safe harbor provision, reiterated prior cases’ determination that the uses need not be solely related to FDA approval, but rather, that the only uses that would be protected were those within the safe harbor. Finally, the Court again deemed the non-use of the devices irrelevant, as nothing in the statute required actual use.

Judge Lourie dissented, not because he necessarily viewed the district court’s or the majority’s application as squarely incorrect under existing precedent, but because he believed that existing precedent did not expressly give proper weight to the statute’s use of the word “solely.” Applying a plain text analysis, Judge Lourie argued that the safe harbor [...]

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Mandamus Denied but Jurisdictional Door Left Open a Crack

by | Apr 4, 2024 |

The US Court of Appeals for the Federal Circuit denied a patent owner’s writ of mandamus seeking to prevent a defendant from amending its answer to add an affirmative licensing defense, but also noted that the defense was added only after the district court found that there were no remaining claims. In re VLSI Technology LLC, Case No. 24-116 (Fed. Cir. Mar. 18, 2024) (Moore, Taranto, Chen, JJ.)

VLSI asserted four patents against Intel in the Northern District of California. In December 2023, the district court granted summary judgment that two of the patents were not infringed and denied summary judgment of noninfringement on the remaining two patents. The parties additionally submitted cross motions for summary judgment on a licensing defense that turned on a forum selection clause, but the court denied both motions. To deprive the court of jurisdiction, VLSI granted Intel a covenant not to sue for infringement of the remaining two patents in the case. Two days later, Intel moved to amend its answer to add a counterclaim for a declaratory judgment that Intel was licensed to VLSI’s entire patent portfolio. The district court granted Intel’s motion, and VLSI filed a mandamus petition to block Intel’s amendment.

The Federal Circuit denied VLSI’s petition for two primary reasons. First, the Court determined that VLSI had not shown that it had no other available means of obtaining relief. The district court expressly invited the parties to brief issues pertaining to Intel’s licensing defense in subsequent briefing, and VLSI had since filed a motion to dismiss pertaining to this very issue. The Court also noted that VLSI could raise this issue on appeal after a final judgment. Second, the Court determined that VLSI failed to show that the district court abused its discretion in allowing Intel to amend its answer, finding that Intel acted diligently in seeking to amend its answer and that VLSI had long since known about the potential defense.

With respect to the substantive issue of whether the district court had subject matter jurisdiction, the Federal Circuit declined to offer an opinion at this stage. Nevertheless, in an apparent message to the court below, the final sentence of the Court’s opinion reads, “[w]e only note that Intel’s motion to amend its answer was filed after the court determined there were no remaining claims, such that no case or controversy remained before the court.”



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

by | Apr 4, 2024 |

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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Same Product in Different Packaging May Constitute Separate Market for Antitrust Purposes

by | Mar 28, 2024 | ,

Addressing an issue of first impression, the US Court of Appeals for the Second Circuit concluded that two medications that contain the same ingredients but are packaged in different forms constitute separate markets for purposes of assessing antitrust violations. Regeneron Pharm., Inc. v. Novartis Pharma AG, Case No. 22-0427 (2d Cir. Mar. 18, 2024) (Parker, Lee, Merriam, JJ.)

Regeneron sued Novartis in the US District Court for the Southern District of New York alleging antitrust violations under the Sherman Act and New York state law claims. The specific products at issue were prescription medications used to treat the overproduction of vascular endothelial growth factor (VEGF). VEGF is a naturally occurring protein but, if overproduced, can lead to eye disorders, including permanent blindness. Both Regeneron and Novartis produce medication to combat overproduction of VEGF. The first form of anti-VEGF medications developed was packaged into vials and administered in a two-step process where a physician draws the product into a syringe then injects the product into the patient’s eye. However, a newer version of anti-VEGF drugs come in a prefilled syringe (PFS) designed to be administered in one step. The PFS packaging carries a significantly lower risk of complications and infections. PFSs have become the “preferred way [to] administer [] anti-VEGF medications.” Novartis moved to dismiss the complaint under Fed. R. Civ. P. 12(b)(6). After the district court granted the motion, Regeneron appealed.

The district court reasoned that original and newer products competed in the same market because they were the exact same medication, just sold in different forms. The Second Circuit disagreed. PFSs reduce the likelihood of complications and have become the preferred form of administration for treatment of VEGF overproduction over vials. The Second Circuit concluded that the district court improperly focused its analysis on whether the two products were “functional substitutes” and not on whether they were “economic substitutes.” The Second Circuit concluded that the district court had applied the improper standard for the relevant market and should instead consider whether the two drugs are economic substitutes. That is to say, the district court should look to whether the different packaging for the VEGF treatments are reasonably interchangeable by consumers. Regeneron alleged they are not due to PFSs’ preferred status among physicians (although PFSs are more costly than vials).

As to the state law claims, the district court dismissed Regeneron’s tortious interference claims as untimely. On appeal, Regeneron argued that Novartis should be equitably estopped from invoking the statute of limitation because the defendants “took steps to prevent Regeneron from learning of Novartis’s tortious interference until after the statute of limitation period had expired.” The Second Circuit found that Novartis concealed a co-inventor’s role in the procurement of a patent, which Regeneron only found out about during subsequent patent litigation, and that such concealment was in violation of a contract. Thus, the Court “conclude[d] that [Regeneron’s] allegations were sufficient to permit Regeneron to invoke equitable estoppel.” Additionally, the complaint “plausibly alleged a claim for tortious interference with contract.”



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PTO to Patent Examiners: Make Interpretation of Means-Plus-Function Claims Clear in the Record

by | Mar 28, 2024 |

On March 18, 2024, the US Patent & Trademark Office (PTO) issued a memorandum to patent examiners addressing means-plus-function and step-plus-function claim limitations and how to clearly articulate, in the prosecution record, the PTO’s interpretation of such claim limitations. The goal of the memorandum is to ensure consistency in connection with the examination of such limitations, provide both the applicant and the public with notice regarding the claim interpretation used by the patent examiner, and provide the applicant an opportunity to advance a different claim interpretation early in the prosecution.

As stated in 35 U.S.C. §112(f), “[a]n element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” The memorandum does not suggest any changes in interpretation of the statute.

One aspect of the memorandum is to remind examiners of the resources and guidance available when examining means-plus-function and step-plus-function claim limitations, specifically MPEP §§ 2181-2187 and refresh training. In accordance with the guidance, the primary steps when examining such claim elements include:

  • Determining whether a claim limitation invokes § 112(f)
  • Ensuring the record is clear with respect to invoking § 112(f)
  • Evaluating the description necessary to support a § 112(f) claim limitation under §§ 112(a) and (b).

To determine whether a claim limitation invokes §112(f), the guidance instructs examiners to employ the three-prong analysis set forth in MPEP § 2181, subsection I. Using this analysis, recitation of the terms “means” or “step” in association with functional language, rather than structure, material or acts for performing that function, should be interpreted as claim limitations invoking § 112(f). However, where these terms are accompanied by structure, materials or acts for performing the function, § 112(f) is not invoked. On the other hand, a limitation reciting functional language along with a generic placeholder term instead of “means,” which fails to recite sufficiently definite structure for performing the function, would nonetheless invoke § 112(f), according to a proper analysis. Examples of such generic placeholders include “mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for” and “system for.”

An important caveat in the memorandum states that “[e]stablishing the interpretation of § 112(f) limitations in writing during prosecution is critical in supporting the agency goal of establishing a clear prosecution record.” The guidance advises examiners that form paragraphs are available in support of meeting this objective, which serve to inform “the applicant, the public, and the courts . . . as to the claim construction the examiner used during prosecution. This further informs the applicant, the public, and the courts (and the PTO for any post-grant review procedures) as to how the examiner searched and applied prior art based on the examiner’s interpretation of the claim.”

The memorandum further emphasizes the need to [...]

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New PTAB Claim Construction? Give the Parties Review Opportunity

by | Mar 28, 2024 |

The US Patent & Trademark Office (PTO) Director vacated Final Written Decisions issued by the Patent Trial & Appeal Board that presented a sua sponte construction of a claim term in dispute, holding that the parties were not provided adequate notice of the Board’s new construction. Assa Abloy AB v. CPC Patent Technologies Pty., Ltd., IPR2022-01006, -01045, -01089 (PTAB Decision Review Mar. 15, 2024) (Vidal, PTO Dir.)

The Board issued Final Written Decisions in three inter partes reviews (IPRs), holding that the petitioner failed to demonstrate that any of the challenged claims were unpatentable. The petitioner requested Director Review, raising three issues concerning the Final Written Decisions’ treatment of the claim term “biometric signal”:

  1. The Board’s construction newly added a limitation that neither the petitioner nor the patent owner proposed
  2. The Board’s construction was erroneous
  3. The Board inconsistently addressed this claim limitation among the IPRs at issue.

The Director decided that review was appropriate.

The Director explained that in view of the petitioner’s and patent owner’s divergent post-institution positions regarding this limitation, the Board had authority to construe “biometric signal” even though its institution decisions indicated that the Board would give this claim term its plain and ordinary meaning. The petitioner argued that the term meant “the input and output of the biometric sensor,” and the patent owner argued that the term meant a “physical attribute of the user” (i.e., a fingerprint, facial pattern, iris, retina or voice). The Board held that it meant “a physical or behavioral biometric attribute that provides secure access to a controlled item.”

The Director vacated and remanded the Final Written Decisions, explaining that the Board failed to provide the petitioner and the patent owner reasonable notice of its new construction or the opportunity to present arguments concerning it, as required under the Administrative Procedure Act (APA). The Director noted that neither party requested the Board’s inclusion of a construction that required an attribute of the claimed signal to “provide[] secure access to a controlled item” and concluded this was the sort of “difficult to imagine” sua sponte construction that the US Court of Appeals for the Federal Circuit held (in its 2021 decision in Qualcomm v. Intel) lacked sufficient notice if appearing for the first time in a Final Written Decision.

The Director instructed that on remand the Board should authorize the petitioner to file a supplemental briefing that addresses the Board’s construction and its application to the asserted prior art and authorize the patent owner to respond to the petitioner’s supplemental briefing.

The Director also noted that the patent owner’s proposed claim construction in the IPRs was similar to the construction that the Board adopted in its institution decisions in other IPRs challenging two of the patents at issue. In recognition of this situation, the Director also invited the petitioner, in its supplemental briefing, to address the perceived inconsistencies in these claim constructions.



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Specially Convened Rehearing Panel Vacates IPR Institution Denial

by | Mar 21, 2024 | ,

In a rehearing decision issued by a Delegated Rehearing Panel specially convened by the US Patent & Trademark Office (PTO) Director, the Patent Trial & Appeal Board vacated a prior panel decision denying institution, modified the claim construction to account for a “clear and unmistakable” prosecution history disclaimer, and remanded for further proceedings consistent with the modified claim construction. SynAffix B.V. v. Hangzhou DAC Biotech Co., Ltd., No. IPR2022-01531, Paper 23 (PTAB Mar. 4, 2024) (Kim, Acting Deputy Chief APJ; Gongola, Vice Chief APJ; Worth, Acting Senior Lead APJ).

SynAffix filed a petition for inter partes review (IPR) of certain patent claims owned by Hangzhou DAC Biotech. The claims at issue are directed to a hydrophilic linker of formula (I), reproduced below.

A Board panel issued a prior decision denying institution. In the prior decision, the Board noted that it was undisputed that moieties Y or Z enable connection of the linker to a cell-binding agent (Y) or a cytotoxic drug (Z), and that Q and T are one sulfone, sulfoxide or phosphinate. That said, the central issue was whether Y or Z must act independently or whether they can act in concert with an adjoined Q or T compound. The Board concluded that Y and Z must act independently to enable their respective chemical reactions without assistance from an adjoining Q or T compound, because during prosecution the patent owner disclaimed embodiments in which Y or Z was adjoined to a sulfone compound with no additional adjacent sulfone, sulfoxide or phosphinate to overcome a rejection based on a prior art reference (Lees). Thus, the Board denied institution.

SynAffix subsequently sought review by the Director. The Director issued an order delegating director review to a rehearing panel. The rehearing panel reviewed whether the prior decision misapprehended or overlooked any issue raised in the request for director review. In particular, the rehearing panel considered whether, when the hydrophilic linker contains a vinylsulfone group, one of Y and Z may be understood to be a vinyl group with one of Q and T as a sulfone group (i.e., the vinyl group and the sulfone group mapped to separate letters), or instead whether one of Y and Z must be a vinylsulfone group (i.e., the vinyl group and the sulfone group mapped to the same letter).

While the rehearing panel agreed with the first version of the prosecution history disclaimer in the prior decision, it rejected a second under which two sulfone groups would not fall within the scope of the claim. First, the rehearing panel accepted the Board’s prior finding that the patent owner disclaimed embodiments in which Y or Z was adjoined to a sulfone compound with no additional sulfone, sulfoxide or phosphinate. However, the conclusion (in the prior decision) that the challenged independent claim excludes compounds in which the sole terminal group is vinyl sulfone without one or more adjacent Q and [...]

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