IP UPDATE
Exploring the Latest in Intellectual Property Law
IP UPDATE
Exploring the Latest in Intellectual Property Law
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PTO Director Requests Input on Patent Trial & Appeal Board Decision Regarding Duty of Candor

by | Nov 9, 2023 |

On May 3, 2023, the Patent Trial & Appeal Board granted a motion for sanctions brought by Spectrum Solutions LLC against Longhorn Vaccines & Diagnostics LLC.[1] The resulting sanctions order canceled five Longhorn patents. The Board found that Longhorn failed to meet its duty of candor by selectively and improperly withholding material results inconsistent with its patentability arguments directed to the canceled claims covering chemical compositions, collection systems and methods for biological specimen collection, including preserving biological samples, killing pathogens and preventing nucleic acid degradation. Now, US Patent & Trademark Office (PTO) Director Katherine Vidal has initiated sua sponte review of the Board’s sanctions order.

In her order issued October 27, 2023, the Director authorized further briefing by both parties, as well as amicus curiae briefs in response to the Board’s decision and analysis for the Director’s review. The Director particularly seeks input on the following issues in the context of situations where relevant factual evidence has been withheld during an America Invents Act proceeding:

  • Which PTO regulations are implicated? Do such regulations include 37 C.F.R. § 1.56?
  • Is it an appropriate sanction for the Board to deem the claims unpatentable in its written decision? Is such a sanction proportionate to the harm caused by the party, taking into account the integrity of the patent system?
  • What other sanctions are appropriate, either in addition to or in place of applying adverse judgment in a final written decision to deem claims unpatentable?

Amicus briefs (of no more than 20 pages) limited to the issues and questions identified above should be submitted to Director_PTABDecision_Review@uspto.gov no later than four weeks after the October 27, 2023, entry date of the order.

For further details, see Order (Paper 133) in each of the listed IPR proceedings.

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[1] See IPR2021-00847 (US 8,084,443), IPR2021-00850 (US 8,293,467), IPR2021-00854 (US 8,669,20), IPR2021-00857 (US 9,212,399) and IPR2021-00860 (US 9,683,256).



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Chilly Adventures: Design Patent Prior Art Comparison Applies to Article of Manufacture

by | Sep 28, 2023 |

Addressing a matter of first impression concerning the scope of prior art relevant to a design patent infringement analysis, the US Court of Appeals for the Federal Circuit concluded that “to qualify as comparison prior art, the prior-art design must be applied to the article of manufacture identified in the claim.” Columbia Sportswear North America, Inc. v. Seirus Innovative Accessories, Inc., Case Nos. 21-2299; -2338 (Fed. Cir. Sept. 15, 2023) (Prost, Reyna, Hughes, JJ.)

Columbia owns a design patent that covers an ornamental design of a heat reflective material. Seirus markets and sells products (e.g., gloves) made with material that it calls HeatWave. An image of Columbia’s patented design and Seirus’s HeatWave material appear below:

Columbia Patented Design

Seirus HeatWave

Columbia sued Seirus for infringement. After the district court granted summary judgment of infringement, Seirus appealed to the Federal Circuit. The Court issued its decision in Columbia I, concluding that the district court improperly declined to consider the effect of Seirus’s logo in its infringement analysis and resolved certain issues that should have been left to the jury. The Court therefore vacated summary judgment and remanded for further proceedings.

On remand, the district court held a trial. Before trial, the district court limited admissible comparison prior art to “wave patterns of fabric,” declined to instruct the jury that “prior art” referred to prior designs of the claimed article of manufacture, and declined to instruct the jury that it did not need to find that any purchasers were deceived or that there was any actual or likelihood of confusion among consumers in the marketplace. Seirus was permitted to admit three prior art references that disclosed fabric, and Columbia was precluded from distinguishing the references by arguing that they did not disclose heat reflective material. The jury returned a verdict of noninfringement. Columbia appealed.

Among other things, Columbia challenged the exclusion of evidence and jury instructions concerning comparison prior art, and the jury instructions implicating Seirus’s logo.

The Federal Circuit began by discussing the appropriate prior art comparison in the context of design patent infringement. Citing its 2008 en banc decision in Egyptian Goddess v. Swisa, the Court explained that under the ordinary-observer test governing design patent infringement, prior art can help highlight distinctions and similarities between the claims and the accused design. For instance, when a claimed design is close to a prior art design, small differences between the accused design and the claim design are likely to be important. Conversely, if an accused design copied a particular feature of the claimed design that departs from the prior art, the accused design is likely to be regarded as deceptively similar to the claimed design, and thus infringing.

The question of first impression before the Federal Circuit was the proper scope of comparison prior art that may be [...]

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PTO Issues Oral Hearing Guide for Patent Trial & Appeal Board Proceedings

by | Sep 28, 2023 |

On August 31, 2023, the US Patent & Trademark Office (PTO) published an Oral Hearing Guide to aid parties with oral arguments before the Patent Trial & Appeal Board. The newest Oral Hearing Guide updates the 2019 Oral Hearing Guide published on August 30, 2019, and is meant to be read in conjunction with the procedures set forth in the 2019 PTAB Trial Practice Guide.

The Oral Hearing Guide addresses the following topics:

  • PTO locations for oral hearings
  • Request for an oral hearing
  • Notification of hearing in ex parte and reexamination hearings
  • Notification of hearing in America Invents Act (AIA) trials
  • Authorized persons to present oral arguments
  • Attendance at hearings
  • Guidelines for counsel during argument.

With a few minor exceptions, the administrative processes and procedures largely mirror those set forth in the 2019 Oral Hearing Guide and the 2019 PTAB Trial Practice Guide. The key changes are summarized below.

A Request for Oral Hearing in ex parte and reexamination proceedings must be filed as a separate paper with the required fee paid within a non-extendable time period. The Board will issue a Notice of Hearing to the parties involved once a case has been scheduled for oral argument, typically eight weeks before the scheduled hearing session. The Notice of Hearing provides information about the scheduled hearing, including the date, time, location, appearance options and general information about the oral hearing procedures before the Board.

In trial proceedings under the AIA—i.e., inter partes reviews (IPRs), covered business method reviews (CBMs or CBMRs), post-grant reviews (PGRs) and derivations—each party to a proceeding is afforded an opportunity to present its case before at least three members of the Board and is notified of the date and location options of an oral hearing in a Scheduling Order. The Guide further elaborates on the processes for requesting an oral argument, including the issuance of the Notice of Hearing (or Scheduling Order) when an oral hearing is requested. The Scheduling Order notifies the parties of the finalized hearing date, time and location. Once the Board has issued a Hearing Order, parties requiring a different arrangement should contact the Board with their request.

The Guide stipulates that the parties should state in their respective requests for oral argument whether they prefer a video hearing or an in-person hearing, and for in-person hearings, which available location the party prefers. To the extent the parties disagree, they should meet and confer. If the dispute cannot be resolved by meeting and conferring, the parties should inform the Board of each party’s individual preferences. The Board will notify the parties of its decision in accordance with current office policy.

The Guide further provides updated information stipulating that optional demonstrative exhibits must be marked with the words “DEMONSTRATIVE EXHIBIT – NOT EVIDENCE” in the footer and further elaborates on the procedures for parties to request pro hac vice admission for non-registered patent practitioners to participate in proceedings. Finally, the Guide discusses [...]

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The End Is Not So Near: Patent Term Adjustments Count in Obviousness-Type Double Patenting Determinations

by | Sep 7, 2023 |

Addressing for the first time how patent term adjustments (PTAs) interact with obviousness-type double patenting (ODP), the US Court of Appeals for the Federal Circuit concluded that when members of a patent family have different expiration dates due to PTAs, the earlier expiring family members can be used as a basis for an ODP invalidity challenge against the later expiring family members. In re Cellect, LLC, Case Nos. 2022-1293; -1294; -1295; -1296 (Fed. Cir. Aug. 28, 2023) (Lourie, Dyk, Reyna, JJ.)

Cellect owns several patents directed to devices with image sensors, such as personal digital assistant devices and phones. Each patent claims priority from a single application. None of the patents were subject to a terminal disclaimer, and each was granted PTA under 35 U.S.C. § 154(b) because of PTO delay during prosecution. Had the patents not been granted PTA, each one would have expired on the same date as the original application.

After Cellect sued for infringement, the defendant requested ex parte reexaminations and asserted that the patents were unpatentable based on ODP. During the reexaminations, the Examiner “determin[ed] that the challenged claims were obvious variants of Cellect’s prior-expiring reference patent claims” because “although the ODP invalidating reference patents form a network across the four ex parte reexamination proceedings, all invalidated claims can be traced back to the single family member [now expired] patent that did not receive a grant of PTA.” The Patent Trial & Appeal Board affirmed the Examiner’s finding. Cellect appealed.

The Federal Circuit began with the inquiry for determining unpatentability based on ODP and whether, in that context, a patent’s expiration date includes a duly granted PTA under 35 U.S.C. § 154. While the Court recognized that the relevant expiration date for an ODP analysis where a patent received a patent term extension (PTE) is the pre-PTE expiration date, the Court concluded that, in the context of patents that have received PTAs, the relevant expiration date for analyzing ODP is the expiration date accounting for the PTA regardless of whether a terminal disclaimer has been filed. The Court reasoned that when determining whether claims are unpatentable for ODP, PTA and PTE, they “should be treated differently” because each is governed by different statutes that were designed to address different circumstances. While both PTAs and PTEs were intended to recover lost patent terms, PTAs were designed to extend patent terms because of administrative delays in patent processing and preclude the extension of a patent term past a terminal disclaimer. PTEs were designed to extend a patent term because of regulatory delays in product approval and are not foreclosed by a terminal disclaimer. As such, the Court reasoned that not contemplating a PTA when analyzing ODP would “frustrate the clear intent of Congress” because “when a terminal disclaimer has been entered in a patent subject to PTA, no patent (or claim) may be extended beyond the disclaimed expiration date.”

The Federal Circuit next considered whether examiners are required to consider “equitable concerns” such as good faith when [...]

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Petitioner Reply May Include New Evidence if Responsive to Patent Owner and Based on Original Legal Contentions

by | Aug 24, 2023 |

Addressing the issue of new invalidity theories offered during inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit held that a petitioner does not improperly offer new theories when it merely expands on previously raised arguments and responds to a patent owner’s assertions without advancing a “meaningfully distinct [invalidity] contention.” Rembrandt Diagnostics, LP v. Alere, Inc., Case No. 21-1796 (Fed. Cir. Aug. 11, 2023) (Moore, C.J.; Reyna, Dyk, JJ.) The Court further concluded that the patent owner waived its new theories argument by raising a general objection that did not identify which theories were allegedly new.

Alere filed an IPR petition challenging a Rembrandt patent directed to test assay devices and methods for testing biological fluids. Alere argued that the claims were obvious over two combinations of prior art references (among other grounds not at issue on appeal): MacKay in view of Charm or May, and Tydings in view of MacKay or Lee-Own. On remand from a previous appeal, the Patent Trial & Appeal Board ordered briefings on all non-instituted grounds set forth in Alere’s petition. Rembrandt filed a patent owner response without an expert declaration. Alere filed a reply attaching a declaration from its expert and responding to arguments raised by Rembrandt in its response and by the Board in its institution decision.

In a sur-reply, Rembrandt generally argued that Alere “resort[ed] to new theories in reply” but did not specifically contest the two combinations at issue while specifically objecting to other allegedly new theories. Relying on Alere’s expert testimony, the Board issued a final written decision finding the claims at issue unpatentable over the MacKay and Tydings combinations. Rembrandt unsuccessfully petitioned for Director rehearing and then appealed the decision, arguing that the Board abused its discretion by relying on Alere’s new theories and evidence and that there was a dearth of substantial evidence to support the Board’s determinations.

The Federal Circuit first considered whether Rembrandt had forfeited its new theories argument by raising a general objection without expressly objecting to the obviousness grounds at issue. Underscoring the fact that Rembrandt had specifically identified and objected to other allegedly new theories, the Court concluded that Rembrandt’s general objection was insufficient and that Rembrandt’s “objection” argument had been forfeited. The Court noted that holding otherwise would be unfair to the parties and the Board because such a general objection could not provide adequate notice.

Even though Rembrandt’s new theories argument had been waived, the Federal Circuit concluded that Alere’s reply arguments did not constitute new theories and evidence. As the Court noted, in its reply a petitioner must identify “with particularity . . . the evidence that supports the grounds for each challenge to each claim” and may “only respond to arguments raised in the corresponding opposition, . . . patent owner response, or decision on institution.” The Court further explained that a petitioner who asserts previously unidentified prior art disclosures or embodiments in its reply to make a “meaningfully distinct contention” impermissibly raises a [...]

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New Claim Construction in Patent Owner’s Post-Initiation IPR Response? Sure, Charge Away

by | Aug 17, 2023 |

Addressing the issue of new claim constructions presented by a patent owner after the institution of inter partes review (IPR) proceedings, the US Court of Appeals for the Federal Circuit found that a petitioner is entitled to argue and present evidence under the new construction so long as it relies on the same prior art embodiments used in the petition. Axonics, Inc. v. Medtronic, Inc., Case No. 22-1532 (Fed. Cir. Aug. 7, 2023) (Dyk, Lourie, and Taranto, JJ.)

Medtronic owns two patents directed to the transcutaneous charging of implanted medical devices via inductive coupling between a primary coil in an external charger and a secondary coil in the implanted device. The relevant claims of each patent require the external charger’s power to be automatically varied based on “a value associated with the current passing through the internal power source” (the value limitation) and “a measured current associated with the current passing through the internal power source” (the measured current limitation).

Axonics filed two IPR petitions challenging Medtronic’s patents, arguing that the claims were anticipated by three prior art references. Axonics’s petitions did not propose any express claim constructions, but its claim charts stated that the measured current limitation simply narrows the “value” in the value limitation to “measured current” and does not require a separate measurement. Under this “one-input” construction, both limitations would be satisfied if the external power source automatically varied its power output based on the implanted device’s current. In its preliminary response, Medtronic agreed that while claim construction was not necessary, the prior art failed to anticipate the claimed device under the one-input construction. In its institutional decision, the Patent Trial & Appeal Board agreed that “no term requires express construction.”

In its patent owner response, Medtronic (for the first time) advanced a new claim construction, arguing that the value limitation and the measured current limitation required separate inputs (the two-input construction). In Axonics’ reply, it defended the one-input construction and further argued that the three prior art references also disclosed the claimed device under the two-input construction. In support of its reply, Axonics submitted a supplemental expert declaration citing additional disclosures in the prior art references pertaining to the same embodiments relied upon in the petition. Medtronic argued that it would be prejudicial for the Board to consider Axonics’ new reply arguments without providing Medtronic an opportunity to submit a supplemental expert declaration. Medtronic, however, did not seek leave to submit a new declaration.

In its final written decision, the Board adopted the two-input construction and declined to consider Axonics’ arguments and evidence under the new construction, considering them to be improper reply arguments. Axonics appealed.

The Federal Circuit acknowledged that a petition is required to identify “in writing and with particularity…the grounds on which the challenge to each claim is based, and the evidence that supports the grounds.” To that end, a petitioner may not submit new evidence or arguments in a reply that could have been raised earlier but may respond to new arguments [...]

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Reissue Boat Won’t Float: “Original Patent” Rule Sinks New Floating Grill Claims

by | Jul 20, 2023 |

Addressing the same invention requirement for reissue patents, the US Court of Appeals for the Federal Circuit affirmed a Patent Trial & Appeal Board decision to reject an overly broad reissue application. In re Float‘N’Grill LLC, Case No. 22-1438 (Fed. Cir. July 12, 2023) (Prost, Linn, Cunningham, JJ.)

Float‘N’Grill (FNG) owned a patent directed to a floating device that supports a grill so that users can grill food while in water. The patent’s specification lays out a single embodiment, illustrated in Figure 1 below, which includes a float (20) that has two supports (46, 48), each of which “includes a plurality of magnets” (60) so that the grill can be removably attached to the float:

FNG filed a reissue application that claimed new ways to “more generically” removably attach a grill to the float. In rejecting the reissue claims, the Examiner found that three of the new requested claims required zero magnets, three claims required one magnet, and one claim did not specifically require magnets but referred to a magnet in the preamble. This was in contrast to the issued patent’s only embodiment, which required multiple magnets. The Examiner, therefore, rejected the reissue claims for failure to meet the “original patent” requirement of 35 U.S.C. § 251. The Board affirmed. FNG appealed.

The question on appeal was whether FNG’s newly requested claims complied with § 251. The Federal Circuit explained that the only path to expanding the coverage of an issued patent is through a reissue application, which is subject to § 251’s limitations. Pertinent here, § 251 requires reissue claims to be directed to the same invention disclosed in the original patent. Citing Supreme Court and Federal Circuit decisions, the Court described the “original patent” requirement as a question of whether the issued patent’s disclosed invention “on its face, explicitly and unequivocally describe[s] the invention as recited in the reissue claims.”

Turning to FNG’s reissue claims, the Federal Circuit agreed with the Board, finding that the new claims were not directed to the same invention as the original patent and thus failed to satisfy § 251. The Court explained that the specification of FNG’s issued patent had just one embodiment, which featured “a plurality of magnets” to removably attach a grill to the floating device. The reissue claims, however, contemplated more general attachments without magnets.

FNG argued that its claims were acceptable under § 251 because the magnets were a “non-essential embodiment” of the invention. The Federal Circuit disagreed for four reasons:

  1. An element of a patent may be deemed essential even if the patent does not explicitly state as much. Thus, the magnets were essential to FNG’s original patent, even if not labeled so.
  2. It is irrelevant that a person of skill in the art may know to replace an original patent element with “some other undisclosed mechanism” to reach the same result. Here, a new way to attach a grill to [...]

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Federal Circuit to Revisit Whether KSR Extends to Design Patents

by | Jul 13, 2023 |

Granting a petition for rehearing en banc, the US Court of Appeals for the Federal Circuit decided to revisit the effect of the Supreme Court’s 2007 decision in KSR International v. Teleflex on design patents. LKQ Corporation v. GM Global Technology Operations, Case No. 21-2348 (Fed. Cir. June 30, 2023) (per curiam). The Federal Circuit withdrew its earlier panel decision addressing KSR’s application to design patents.

This case arose from an inter partes review (IPR) filed by LKQ against GM alleging that GM’s design patent for a vehicle fender was obvious and/or anticipated. In its original opinion, the Federal Circuit applied its predecessor court’s design patent test for obviousness in In re Rosen (CCPA 1982), as well as its decision in Durling v. Spectrum Furniture (Fed. Cir. 1996), ultimately finding that GM’s design patent was not obvious or anticipated and affirming the Patent Trial & Appeal Board’s decision. The Federal Circuit determined that it was unclear whether the Supreme Court had overruled Durling and Rosen with KSR, so it did not apply KSR. Judge Lourie provided an additional opinion that KSR did not overrule Rosen. Judge Stark concurred in the judgment but found that LKQ had forfeited its argument that KSR overruled Rosen.

In its order for en banc review, the Federal Circuit asked the parties to address whether KSR abrogates Rosen and Durling and whether KSR applies to design patents regardless of whether it overrules or abrogates Rosen and Durling. Specifically, the Court inquired whether KSR’s “expansive and flexible approach” means that Durling’s two requirements should be modified or eliminated. Durling’s first requirement is that “[b]efore one can begin to combine prior art designs . . . one must find a single reference, ‘a something in existence, the design characteristics of which are basically the same as the claimed design.’” Its second requirement is that secondary references “may only be used to modify the primary reference if they are ‘so related to the primary reference that the appearance of certain ornamental features in one would suggest the application of those features to the other.’”

The Federal Circuit also asked the parties to address the appropriate test for evaluating the obviousness of design patents in the event the Rosen-Durling test was to be eliminated or modified.

The Federal Circuit further requested that the parties address whether eliminating the Rosen-Durling test would cause uncertainty in a settled area of law. Finally, the Court asked whether any differences between design patents and utility patents are relevant to the design patent obviousness inquiry.

The Federal Circuit indicated that the issues of anticipation and forfeiture from the initial appeal were preserved, but that additional briefing on those issues was not required. The Court invited the United States to participate as amicus curiae.

Practice Note: With the Federal Circuit granting rehearing en banc, there is a possibility that the Court may extend the obviousness analysis of KSR to design patents.



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Coons and Tillis Introduce Two Bills Intended to Change Patent Landscape

by | Jul 13, 2023 |

In late June 2023, Senators Chris Coons (D-DE) and Thom Tillis (R-NC) introduced two bills in Congress that, if enacted, would change the patent adjudication landscape:

The PREVAIL Act is essentially a reintroduction of the previously unsuccessful STRONGER Patents Act of 2019 bill and would change fundamental aspects of how the Board operates. Under current practice, the Board judges who rules on institution and also decides the outcome of an instituted proceeding. Under the PREVAIL Act, institution decisions would be made by a separate set of judges from those that render a decision on a petition’s merits. Through proposed changes to the initiation and estoppel provisions, a patent challenger could bring its attack on patent validity in either the district court or the Board, but not both. And as part of the harmonization of district court and Board proceedings, the PREVAIL Act would adopt the “clear and convincing” standard for Board review and codify existing Board practice of applying the same claim construction standard as district courts apply.

The PREVAIL Act would also change who can bring issues to the Board by imposing standing and revised real-party-in-interest requirements. An IPR petitioner would have to establish standing equivalent to that required for a district court declaratory judgment action. Moreover, anyone who financially contributes to an IPR would be deemed a real party in interest to avoid multiple petitions backed by the same entity. To reduce the multiplicity of proceedings, the PREVAIL Act would establish a presumption against a joinder for time-barred petitions. The PREVAIL Act also includes several provisions directed to the independence and transparency of the Board’s decision-making, including establishing a code of conduct and requiring recordation of the Director’s actions that affect Board proceedings.

Turning to subject matter eligibility, the Patent Eligibility Restoration Act would overrule Supreme Court decisions importing a judicial exception to Section 101 and would codify many of the existing categories of ineligible subject matter, including mathematical formulae; substantially economic, financial, social, cultural and artistic practices (in other words, fundamental human activity); natural processes and products made independent of human activity; and mental processes. The Patent Eligibility Restoration Act specifically would authorize early resolution and limited discovery on Section 101 ineligibility.

Practice Note: Although both acts have been introduced before without much success, Congress’s present focus on technology (such as artificial intelligence) may serve to propel one or both bills forward. Of course, it remains to be seen whether Congress has an appetite for modifying patent law, particularly in the lead-up to an election year.



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Analogous Art Must Be Compared to Challenged Patent

by | May 25, 2023 | ,

The US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board obviousness decision, finding that a prior art reference relating to automotive engine parts was not analogous art to the challenged patent, which related to injection devices used for drug delivery. Sanofi-Aventis Deutschland GMBH v. Mylan Pharmaceuticals Inc., Case No. 21-1981 (Fed. Cir. May 9, 2023) (Reyna, Mayer, Cunningham, JJ.)

Sanofi-Aventis owns a patent directed to a drug delivery device that can be configured to allow for the setting of different dose sizes. The main independent claim of the patent recites a spring washer element with “at least two fixing elements configured to axially and rotationally fix the spring washer relative to the housing.”

Mylan initiated an inter partes review (IPR) proceeding against the patent, arguing that the challenged claims were obvious based on a combination of three prior art references: Burren, Venezia and de Gennes. Burren described a drug injection device that used a coiled spring, while Venezia described a hypodermic syringe with a spring washer having a tongue that fit into a collar to prevent the washer from rotating relative to the collar. The third prior art reference, de Gennes, disclosed a large spring-washer-like device used in automobile engines to maintain the alignment between the engine and the transmission. Sanofi argued that de Gennes was non-analogous art because it was not in the same field of endeavor as the injection devices described in the patent and was not reasonably pertinent to a problem faced by the inventor of the challenged patent.

The Board adopted Mylan’s definition of the problem to be solved, which was “axially fixing two components relative towards each other.” Under this broad definition, the Board found that de Gennes was reasonably pertinent to the challenged patent and that claims were obvious in view of Burren in combination with Venezia and de Gennes. Sanofi appealed.

Sanofi argued that the Board erred in determining that de Gennes was analogous art. The Federal Circuit explained that in evaluating whether a reference is analogous, a patent challenger must compare the reference to the challenged patent. Applying this test, the Court found that substantial evidence did not support the conclusion that de Gennes was analogous to the challenged patent. Although Mylan had mapped de Gennes to certain elements of the challenged claims, there was no evidence that de Gennes—an automobile-related patent—was analogous to the challenged patent—a drug delivery device. The Court also found that statements that de Gennes and the challenged patent were “both interested in solving the same issue . . . [of] accommodating various cartridge lengths” were insufficient to show that de Gennes was analogous to the challenged patent.



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