SubscribeThe US Patent and Trademark Office (USPTO) issued a Notice clarifying its practice as to situations that will require additional information about whether a delay in seeking the revival of an abandoned application, acceptance of a delayed maintenance fee payment, or acceptance of a delayed priority or benefit claim was unintentional. 85 FED. REG. 12222 (Mar. 2, 2020).
Results for "Patent application"
The End Is Not So Near: Patent Term Adjustments Count in Obviousness-Type Double Patenting Determinations
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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Reissue Boat Won’t Float: “Original Patent” Rule Sinks New Floating Grill Claims
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:
- 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.
- 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 the [...]
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Federal Circuit to Revisit Whether KSR Extends to Design Patents
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.
PTO Proposes Patent Fee Increases
The US Patent & Trademark Office (PTO) announced proposed patent fee increases. Patent fees would increase by about 5% across the board because of inflation.
Certain fees would be increased by substantially more than the 5% inflationary increase to reduce subsidization from other fee sources. For example, the overall design patent fees would increase by 48%, based on a 27% increase in filing, search and examination fees and a 76% issue fee increase. The PTO also proposes a 100% increase in the excess claim fee for each claim over 20, and a 25% increase in the fee for each independent claim over three. Because the costs of reviewing patent term extensions is complex, the PTO proposes fee increases of 196% to 468%. The PTO also proposes a fee of $500 for filing an After Final Consideration Pilot (AFCP) 2.0 request, and new fees for filing an information disclosure statement (IDS) that causes the number of applicant-provided citations to exceed 50, 100 or 200 citations, respectively.
To offset the loss of future maintenance fee payments, the PTO proposes fees of $1,500 for continuing applications filed more than three years from the earliest benefit date and $3,000 for continuing applications filed more than seven years from the earliest benefit date.
Other proposed fee increases are intended to expedite the patent examination process. For example, the PTO proposes a 25% increase in the fee for a second request for continued examination (RCE) and an 80% increase for a third or subsequent RCE. The fee for a terminal disclaimer filed after the first action on the merits and before a final rejection would increase by 194%. After a final rejection or notice of allowance, the fee would increase by 371%. On or after a notice of appeal, the increase would be 547%, and the proposed increase for filing a terminal disclaimer in an issued patent would be 724%.
The PTO further proposes increasing Patent Trial & Appeal Board America Invents Act (AIA) trial fees by 25%. The PTO also proposes new fees for inter partes review (IPR) and post grant review (PGR) petitions that exceed the word count limits. For example, the PTO proposes a 50% higher fee for petitions that exceed the word count limit by up to 50%, and a 100% higher fee for those that exceed the limit by up to 100%.
A public hearing is scheduled for May 18, 2023. Those wishing to present oral testimony at the hearing must submit a written request by May 11, 2023. Written comments on the proposed fees will be accepted until May 25, 2023.
The PTO anticipates that the fee changes will be implemented around January 2025.
More details, including a complete list of the proposed fee increases, can be found on the PTO website.
Branding Function Patent Yet Another 1[01] to Bite the Dust
Addressing the patentability of claims directed to digital image branding functions, the US Court of Appeals for the Federal Circuit affirmed a district court’s determination that claims across three related patents were invalid under 35 U.S.C. § 101 for lacking patent-eligible subject matter. Sanderling Mgmt. Ltd. v. Snap Inc., Case No. 21-2173 (Fed. Cir. Apr. 12, 2023) (Chen, Cunningham, Stark, JJ.)
Sanderling owns three patents, each titled “Dynamic Promotional Layout Management and Distribution Rules.” The three patents share a common specification and are generally directed to a method using distribution rules to load digital imaging branding functions to users when certain conditions are met. The specification explains that a distribution rule is “a rule used in determining how to target a group of end users, for instance, a rule that determines that only a group of end users having certain characteristics and/or match a certain requirement.”
Sanderling asserted each of the three patents against Snap in the Northern District of Illinois. Snap moved to transfer venue to the Central District of California and to dismiss the case under Fed. R. Civ. P. 12(b)(6) for failure to state a claim based on the allegation that the asserted patents’ claimed ineligible subject matter under § 101. After the case was transferred, the Central District of California found the claims patent ineligible and granted Snap’s motion to dismiss. Sanderling appealed.
The Federal Circuit reviewed the decision by engaging in the two-step Alice framework for subject matter eligibility. Under step one, the Court determined that the claims were directed to the abstract idea of providing information—in this case, a processing function—based on meeting a condition (e.g., matching a GPS location indication with a geographic location). The Court explained that for computer-related inventions, the relevant question is whether the claims are directed to an improvement to computer functionality or to an abstract idea. The Court found that the claims in issue were not directed to an improvement in computer functionality, but instead to the use of computers as a tool—specifically, a tool to identify when a condition is met and then to distribute information based on satisfaction of that condition.
Even if directed to an abstract idea, patent claims may still be eligible under step two of the Alice framework if there are additional features that constitute an inventive concept. The Federal Circuit, however, found that the claims failed this step also. The Court explained that if a claim’s only inventive concept is the application of an abstract idea using conventional and well-understood techniques, the claim has not been transformed into a patent-eligible application of an abstract idea. The distribution rule of the asserted claims was just that: the application of the abstract idea using common computer components. Accordingly, the Court affirmed the district court’s decision that the patent claims were invalid under § 101.
Practice Note: On appeal, Sanderling argued that the district court erred at step one of the Alice analyses by failing to construe certain claim terms that were allegedly crucial to the determination. [...]
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PTO Adds Green Energy Category to Patents for Humanity Program
On March 6, 2023, the US Patent & Trademark Office (PTO) introduced a new green energy category to its Patents for Humanity Program. This new award category provides business incentives for patent applicants, holders and licensees whose inventions address the challenges of climate change through green energy innovations, including wind, solar, hydrogen, hydropower, geothermal and biofuels technologies. The green energy category joins five other categories of inventions in the Patents for Humanity Program: medicine, nutrition, sanitation, household energy and living standards.
The Patents for Humanity green energy category joins other recent PTO initiatives designed to address climate change, including a joint work-sharing program with the National Oceanic and Atmospheric Administration, expedited examination procedures under the Climate Change Mitigation Pilot Program, and a partnership with the World Intellectual Property Organization’s WIPO GREEN program.
The Patents for Humanity Award is the top award for applicants best representing the Patents for Humanity principles. Award recipients receive public recognition at an awards ceremony sponsored by the PTO. They also receive a certificate to accelerate any of the following matters before the PTO: a patent application, an ex parte reexam or an ex parte appeal to the Patent Trial & Appeal Board. Winners may transfer their acceleration certificates to third parties.
The PTO is now accepting applications for the Patents for Humanity green energy category. For more information about how to apply, visit Patents for Humanity: Green Energy. The deadline for submitting applications is June 1, 2023.
Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations
The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method of use. Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Case No. 23-1186 (Fed. Cir. Feb. 24, 2023) (Lourie, Reyna, Taranto, JJ.)
Jazz Pharmaceuticals holds a new drug application (NDA) for Xyrem, an oral sodium oxybate solution prescribed to help those with certain narcolepsies manage cataplexy. Sodium oxybate itself is no longer covered by patents because it has been used in relation to narcolepsy since the 1960s. For this reason, Jazz built its patent portfolio around Xyrem’s formulation, use and distribution.
Jazz uses a single-pharmacy distribution system for Xyrem, known as a risk evaluation mitigation strategy (REMS). Implementing REMS was a condition of Xyrem’s US Food & Drug Administration (FDA) approval because it mitigates safety risks of dangerous active pharmaceutical ingredients such as sodium oxybate. One of Jazz’s patents is directed to this REMS distribution system. Abbreviated New Drug Application (ANDA) 505(b)(2) NDA (Hybrid NDA) approval is similarly conditioned on implementing a REMS that is sufficiently comparable to any that the NDA holder must implement. The FDA eventually determined that single-pharmacy systems were unnecessary for Xyrem and potentially detrimental.
Avadel submitted a hybrid NDA for a drug that requires only a single nightly dose, unlike Xyrem, which requires a patient to wake up during the night to ingest a second dose. Avadel’s application also proposed a more lenient REMS that utilizes multiple pharmacies. In view of these differences, Avadel believed that it could avoid a lengthy FDA approval process because all of Jazz’s Xyrem Orange-Book-listed patents seemed addressable without making any Paragraph IV certifications. As for the REMS patent, Avadel filed a statement under 21 U.S.C. § 355(b)(2)(B) because the patent was listed as claiming a method of use and Avadel was not seeking approval for the REMS system to which that patent’s claims were directed.
Jazz sued Avadel asserting seven patents, of which the REMS patent was the only Orange-Book-listed patent. Avadel asserted a counterclaim requesting that the district court order Jazz to delist the REMS patent from the Orange Book. The district court subsequently held a Markman hearing finding that the REMS patent’s claims were directed to a system and not a method. The district court granted Avadel’s motion for judgment on the pleadings, finding that the REMS patent did not claim “the drug for which the application was approved” and thus had to be delisted from the Orange Book. Jazz appealed.
Jazz argued that because the FDA permitted the REMS patent to be Orange Book listed, Avadel was prohibited from availing itself of the statutory delisting provision. The Federal Circuit disagreed, concluding that the language of the delisting provision was only concerned with whether a listed patent met the provisions’ conditions at the time of the triggering litigation.
Jazz also argued that there was no evidence that Congress imported patent-law [...]
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KSR Does Not Extend to Design Patents (Yet)
Addressing the standard for obviousness of design patents, the US Court of Appeals for the Federal Circuit, in a per curiam opinion, upheld the Patent Trial & Appeal Board’s finding that a challenged design patent was not obvious over the pre-KSR design patent obviousness test or anticipated. LKQ Corporation v. GM Global Technology Operations, Case No. 21-2348 (Fed. Cir. Jan. 20, 2023) (per curiam) (Lourie, J., concurring) (Stark, J., concurring).
GM owns a design patent for the fender of a vehicle. LKQ Corp. previously held a license to the patent from GM, but negotiations to renew the license failed. Because LKQ continued to manufacture the fender after the expiration of the license, GM sent LKQ notice that it was infringing the patent. In response, LKQ petitioned for an inter partes review against GM, alleging that the patent was obvious and/or anticipated.
The Board found that LKQ had not presented enough evidence to prove that the patent was obvious or anticipated. For purposes of evaluating the obviousness of the design over prior art, the Board defined ordinary observers as “retail consumers who purchase replacement fenders and commercial replacement part buyers.” The Board concluded that, from the perspective of the ordinary observer, there were multiple differences between the patented design and the key reference, a prior art design patent. LKQ appealed.
LKQ argued that the Board erred in finding that there was no anticipation and in applying the obviousness tests of In re Rosen (C.C.P.A. 1982) and Durling v. Spectrum Furniture (Fed. Cir. 1996) because the Supreme Court of the United States overruled those tests in KSR International v. Telflex (2007).
The Federal Circuit upheld the Board’s definition of the ordinary observer. The Court found that retail purchasers of the entire vehicle would not be included in the ordinary observer group because purchasers of the product embodying the design are interested in the part itself, not the vehicle as a whole. The Court went on to uphold the Board’s application of the ordinary observer obviousness test, agreeing that the patented design created different overall impressions from the prior art for purposes of both obviousness and anticipation.
The Federal Circuit then addressed whether KSR overruled the Durling and Rosen tests for obviousness of design patents. The Court found that LKQ properly preserved the argument for appeal by asserting it in its opening brief to the Board. The Court then found that it was unclear whether the Supreme Court overruled Durling and Rosen, and therefore the Court was bound to apply the existing law. In applying the Durling and Rosen tests, the Court found that LKQ had failed to identify “the correct visual impression created by the patented design as a whole” because the prior art patent lacked certain key design features of the patented design. Thus, the Court affirmed the Board’s finding that the patent was not obvious.
Judge Lourie provided an additional opinion and addressed LKQ’s argument that KSR overruled Rosen. Lourie stated that because KSR did not involve design patents, which [...]
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ANDA Filing Alone Insufficient for Induced Infringement of Method Patent
The US Court of Appeals for the Federal Circuit upheld a district court’s findings of invalidity and noninfringement in a Hatch-Waxman case involving two sets of method patents directed to modulating dosages of pirfenidone, a drug used to treat idiopathic pulmonary fibrosis (IPF). The Court found that the first set of patents were obvious over the prior art and standard medical practice, while the second set were not directly infringed in light of actual physician prescription practice. Genentech, Inc. v. Sandoz Inc., Case No. 22-1595 (Fed. Cir. Dec. 22, 2022) (Newman, Lourie, Prost, JJ.) (Newman, J., dissenting).
Sandoz submitted two abbreviated new drug applications (ANDAs) for approval to market a generic version of pirfenidone, which Genentech sells under the brand name Esbriet®. Genentech sued Sandoz under the Hatch-Waxman Act, asserting that Sandoz’s generic version would induce infringement of two sets of patents: one directed to modifying dosages of pirfenidone in patients with abnormal liver biomarkers (LFT patents), and the other directed to avoiding adverse interactions in patients also taking fluvoxamine (DDI patents).
The LFT patents are directed to methods of administering pirfenidone to a patient who has exhibited Grade 2 abnormalities in liver function biomarkers alanine transaminase (ALT) and/or aspartate transaminase (AST) in response to pirfenidone. The LFT patents generally recite the following administration options:
- Temporarily reducing the dose before returning to the full dose
- Maintaining the full dose
- Reducing the dose
- Temporarily discontinuing pirfenidone before returning to the full dose
- Temporarily discontinuing pirfenidone before returning to a reduced dose.
Sandoz’s proposed label included a “Dosage Modification due to Elevated Liver Enzymes” section, which stated that if a patient exhibits grade 2 elevations of ALT and/or AST, “[t]he full daily dosage may be maintained, if clinically appropriate, or reduced or interrupted (e.g., until liver chemistry tests are within normal limits) with subsequent re-titration to the full dosage as tolerated.” Genentech argued that these instructions constituted induced infringement of the LFT patents. The district court disagreed and held that the LFT patents were obvious over the prior art and standard medical practice and that the defendant would not induce infringement because the labels “merely described” the infringing uses but did not recommend them.
The DDI patents are directed to methods for avoiding adverse interactions between pirfenidone and fluvoxamine and generally involve the steps of discontinuing fluvoxamine or modifying the dose of pirfenidone and continuing fluvoxamine. Sandoz’s proposed label warned of the adverse interactions between pirfenidone and fluvoxamine and stated that fluvoxamine should be discontinued prior to administering pirfenidone or the dose of pirfenidone should be reduced. Genentech similarly argued that these instructions constituted induced infringement of its DDI patents, but the district court held that there was insufficient evidence for infringement because Genentech had not shown that a patient would actually be prescribed both pirfenidone and fluvoxamine in practice.
Genentech appealed the district court’s holdings with respect to both the LFT and DDI patents.
LFT Patents
The Federal Circuit first observed that “varying doses in response to the occurrence [...]
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