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Don’t get too comfy: Prosecution disclaimer also applies to design patents

Concluding that the principles of prosecution history disclaimer apply to design patents, the US Court of Appeals for the Federal Circuit reversed a district court’s denial of judgment as a matter of law and entry of a jury verdict that found liability for design patent infringement. Top Brand, LLC v. Cozy Comfort Company, LLC, Case No. 24-2191 (Fed. Cir. July 17, 2025) (Dyk, Reyna, Stark, JJ.)

Top Brand and Cozy Comfort compete in the market for oversized hooded sweatshirts. Cozy Comfort owns a design patent directed to “the ornamental design for an enlarged over-garment with an elevated marsupial pocket.” It accused Top Brand of infringing the patent through its sale of certain hooded sweatshirts and wearable blankets. In response, Top Brand filed a declaratory judgment action seeking findings of noninfringement and invalidity. Cozy Comfort counterclaimed for design patent and trademark infringement.

During prosecution, Cozy Comfort overcame an anticipation rejection by distinguishing the prior art under the ordinary observer test, pointing to specific features such as the shape and placement of the marsupial pocket and the bottom hem line. Top Brand argued that these statements constituted a clear disclaimer of claim scope, and that the accused products fell within the surrendered subject matter.

The district court disagreed, instructing the jury to compare the accused products to the design as claimed (without considering any prosecution disclaimer). The jury found infringement, and the court entered judgment accordingly, denying Top Brand’s motion for judgment as a matter of law. Top Brand appealed.

Top Brand argued that the district court erred by failing to apply prosecution history disclaimer, asserting that the accused design was within the scope of the subject matter Cozy Comfort had disclaimed. Cozy Comfort responded that the disclaimer doctrine does not apply to design patents and, even if it did, Cozy Comfort’s prosecution statements were not sufficiently clear to constitute a disclaimer.

The Federal Circuit disagreed, concluding that prosecution history disclaimer applies to design patents. The Court reasoned that allowing patentees to recapture disclaimed subject matter in litigation would undermine the integrity of the patent system. The Court emphasized that Cozy Comfort’s statements during prosecution clearly surrendered the identified features as supporting a finding of overall similarity. Because the accused design incorporated those surrendered features, the Court concluded that no reasonable jury could find infringement.

Accordingly, the Federal Circuit reversed the district court’s denial of judgment as a matter of law and vacated the jury’s verdict.




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New Administration, Same Patent Reform Bill

A bipartisan group of senators and congressional representatives reintroduced the Patent Eligibility Restoration Act (PERA), which aims to reform the law of patent eligibility under 35 U.S.C. § 101. PERA seeks to address the challenges posed by recent Supreme Court decisions and restore clarity and predictability in the US patent system.

PERA preserves the existing categories of subject matter currently enumerated in § 101 but adds several categories of excluded subject matter. PERA proposes to eliminate all judicial exceptions to patent eligibility, specifying that certain categories, such as mathematical formulas that are not part of an invention, processes that a human could perform, mental processes, unmodified human genes, and unmodified natural material, are not eligible for patents.

A separate bipartisan group of senators and congressional representatives reintroduced the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act, which aims to protect and increase the value of US intellectual property rights by making significant reforms to the Patent Trial & Appeal Board.

PREVAIL seeks to limit Board challenges to entities that have been sued or threatened with a patent infringement lawsuit, close the statutory bar joinder loophole to prevent time-barred entities from joining instituted inter partes review (IPR) proceedings, and prevent serial petitions by applying estoppel at the time the challenge is filed instead of when the Board issues its final written decision.




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Broadcast Alert! Applying Conventional Machine Learning to New Data Isn’t Patent Eligible

The US Court of Appeals for the Federal Circuit affirmed a district court’s ruling that patents applying established machine learning methods to new data are not patent eligible under 35 U.S.C. §101. Recentive Analytics, Inc. v. Fox Corp. et al., Case No. 23-2437 (Fed. Cir. Apr. 18, 2025) (Dyk, Prost, Goldberg, JJ.)

Recentive sued Fox, alleging infringement of four patents designed to tackle long-standing challenges in the entertainment industry – namely, optimizing the scheduling of live events and refining “network maps,” which determine the content aired on specific channels across various geographic markets at set times. These patents aim to streamline broadcast operations and enhance programming efficiency.

The patents at issue can be divided into two categories: network maps and machine learning training. The machine learning training patents focus on generating optimized event schedules by training machine learning models with parameters such as venue availability, ticket prices, performer fees, and other relevant factors. The network map patents describe methods for dynamically generating network maps that assign live events to television stations across different geographic regions. These methods utilize machine learning to optimize television ratings by mapping events to stations and updating the network map in real time based on changes to the schedule or underlying criteria. The patents’ specifications explain that the methods employ “any suitable machine learning technique” using generic computing machines.

Fox moved to dismiss on the grounds that the patents were subject matter ineligible under § 101. Recentive acknowledged that the concept of preparing network maps had existed for a long time. Recentive also recognized that the patents did not claim the machine learning technique. Nonetheless, Recentive argued that its patents claimed eligible subject matter because they involve using machine learning to generate custom algorithms based on training the machine learning model. Recentive characterized its patents as introducing “the application of machine learning models to the unsophisticated, and equally niche, prior art field of generating network maps for broadcasting live events and live event schedules.”

The district court disagreed and granted Fox’s motion. Applying the Alice framework, at step one, the court determined that the asserted claims were “directed to the abstract ideas of producing network maps and event schedules, respectively, using known generic mathematical techniques.” At step two, the court determined that the machine learning limitations were no more than “broad, functionally described, well-known techniques” that claimed “only generic and conventional computing devices.” The court denied Recentive’s request for leave to amend because it determined that any amendment would be futile. Recentive appealed.

For the Federal Circuit, this case presented a question of first impression: whether claims that do no more than apply established methods of machine learning to a new data environment are patent eligible.

Step One

While Recentive claimed that its machine learning approach was uniquely dynamic and capable of uncovering hidden patterns in real time, the Federal Circuit found these features to be merely standard aspects of how machine learning operates. The Court explained that iterative training and model updates are not [...]

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A Patent Without a Pulse: Provisional Rights Don’t Outlive the Patent

The US Court of Appeals for the Federal Circuit dismissed an appeal from a patent applicant seeking provisional rights on a patent that would issue only after it had already expired, finding that the applicant lacked the necessary exclusionary rights to support a claim for provisional rights. In re: Donald K. Forest, Case No. 23-1178 (Fed. Cir. Apr. 3, 2025) (Taranto, Schall, Chen, JJ.)

Donald K. Forest applied for a patent on December 27, 2016. Forest’s patent application claimed priority through a chain of earlier-filed patent applications dating back to March 27, 1995. If Forest’s patent application matured into a patent, it would have expired 20 years after the 1995 priority date (i.e., prior to the 2016 filing date). The patent examiner nevertheless examined and rejected the proposed claims. The Patent Trial & Appeal Board partially affirmed the examiner’s rejection of certain claims on grounds of obviousness and double patenting. Forest appealed.

The Patent & Trademark Office raised a threshold issue that since Forest’s application could only result in an expired patent, he lacked a personal stake in the appeal sufficient to establish jurisdiction. Forest countered that he could still acquire “provisional rights” under 35 U.S.C. § 154(d) – a limited right to royalties for certain pre-issuance activities – despite the expiration of any issued patent as it issued.

The Federal Circuit dismissed the appeal, explaining that since Forest could not be granted a patent until after the patent’s expiration date, he would never receive any exclusionary rights. The Court clarified that provisional rights only arise once a patent issues and crucially do not extend beyond the statutory patent term. Because Forest sought the issuance of a patent that would confer no enforceable rights – either exclusionary or provisional – the Court dismissed the appeal for lack of jurisdiction.

The Federal Circuit’s primary conclusion was predicated on the principle that provisional rights are only available when a patent issues with enforceable exclusionary rights, meaning the patent must issue before its expiration date. The Court emphasized that provisional rights under § 154(d) are expressly provided “in addition to other rights provided by” the patent statute. Because this statutory language indicates that provisional rights are not standalone, the Court determined that provisional rights depend on the existence of a valid, enforceable patent.

According to the Federal Circuit, the entire purpose of provisional rights is to provide temporary relief to the patentee during the gap between publication of a patent application and issuance of a patent. However, such rights only arise if the issued patent provides enforceable rights. The Court reasoned that provisional rights are meant to encourage early publication and protect patentees from pre-issuance infringement, but only as a precursor to full patent protection.

The Court rejected Forest’s interpretation of § 154(d), explaining it would create an anomalous situation where provisional rights could survive without any corresponding enforceable rights, allowing a patentee to collect royalties on a patent that could never be asserted in infringement litigation.

Practice Note: Patent rights, whether provisional [...]

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What’s the (Re)issue? Patent Term Extensions for Reissue Patents

Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original patent should be used to calculate the extension, not the reissue date. Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc., Case No. 23-2254 (Fed. Cir. Mar. 13, 2025) (Dyk, Mayer, Reyna, JJ.)

Merck owns a patent that is directed to a class of 6-mercapto-cyclodextrin derivatives. Four months after the patent issued, Merck applied to the US Food & Drug Administration (FDA) for approval of sugammadex, which it intended to market as Bridion®. During FDA’s review of Merck’s new drug application (NDA), Merck filed a reissue application that included narrower claims. The reissue application issued and included all the original claims and 12 additional claims. FDA regulatory review continued throughout the examination of the reissue application and extended almost two years beyond the date the patent reissued. In all, the FDA regulatory review lasted nearly 12 years.

The Hatch-Waxman Act provides owners of patents related to pharmaceutical products a process to extend the term of their patent rights to compensate for time lost during regulatory review of their NDAs. The act contains a clause providing that “the term of a patent . . . shall be extended by the time equal to the regulatory review period . . . occur[ring] after the date the patent is issued.” Having been unable to market the invention covered by the patent for almost 12 years because of FDA’s regulatory review, Merck filed a PTE application for its reissue patent seeking a five-year extension (the maximum allowed under the act) based on the patent’s original issue date. The US Patent & Trademark Office (PTO) agreed and granted the five-year extension.

Between the reissue date and the PTO’s grant of the five-year extension, Aurobindo and other generic manufacturers had filed abbreviated new drug applications (ANDAs) seeking to market generic versions of Bridion®. Merck sued for infringement. At trial, Aurobindo argued that the PTO improperly calculated the PTE by using the original issue date instead of the reissue date because only 686 days of FDA’s regulatory review occurred after the reissue date, as opposed to the almost 12 years which had passed since the initial issue date. The district court disagreed, finding that Aurobindo’s proposed construction “would undermine the purpose of the Hatch-Waxman Act.” Aurobindo appealed.

Aurobindo argued that the act’s reference to “the patent” referred to the reissue patent because that is the patent for which the patentee was seeking term extension. Merck argued that the act’s text, read in light of other patent statutes and the history of patent reissue, required the opposite conclusion (i.e., a PTE based on the original issue date).

The Federal Circuit agreed with Merck, explaining that while the language of the PTE text may be ambiguous, that ambiguity may be resolved by considering the PTE text in light of the history of [...]

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The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a patent, the US Court of Appeals for the Federal Circuit upheld the district court’s finding of noninfringement. Galderma Laboratories, L.P. v. Lupin Inc., Case No. 24-1664 (Fed. Cir. Dec. 6, 2024) (Moore, C.J.; Linn, Prost, JJ.)

Galderma owns and markets Oracea® (doxycycline USP) 40 mg capsules, which are used to treat papules and pustules associated with rosacea. Galderma’s patents cover a unique once-daily oral formulation of doxycycline, combining 30 mg of immediate release (IR) and 10 mg of delayed release (DR) pellets. Lupin filed an ANDA to market a bioequivalent 40 mg doxycycline product, featuring 22 mg IR and 18 mg DR pellets, and using the same enteric polymer for the DR portion as Oracea®. Galderma sued Lupin under the Hatch-Waxman Act, alleging patent infringement.

Despite Lupin’s different pellet composition, Galderma contended that Lupin’s product effectively contained 30 mg IR and 10 mg DR because of a “weak enteric coat” on the DR pellets, causing early release of some doxycycline. Lupin presented two key pieces of evidence:

  • A two-stage in vitro dissolution test at pH 1.1 and 4.5, showing some DR pellet release at pH 4.5.
  • Bioequivalence data comparing Oracea® and Lupin’s product.

The district court ultimately ruled in favor of Lupin. Galderma appealed. The issue on appeal was whether Galderma’s evidence of bioequivalence and in vitro testing was indeed insufficient to establish literal infringement or infringement under the doctrine of equivalents (DoE).

The Federal Circuit agreed with the district court: in vitro testing and bioequivalence were not enough to establish literal infringement. Crucially, Galderma’s two-stage in vitro dissolution test didn’t accurately mimic in vivo conditions. The Court highlighted that the pH 4.5 environment used in the test wasn’t physiologically relevant for a fasted stomach, which typically has a pH between 1 and 2. Moreover, the bioequivalence data failed to address the differing proportions of IR and DR pellets. Consequently, the Court found no clear error in the district court’s factual findings.

Nor did the DoE save Galderma. The Federal Circuit applied two different tests: the function-way-result test and the insubstantial differences test. Under the function-way-result test the court is charged with determining whether the accused product performs the same function, in the same way, to achieve the same result as the claimed invention. Under the insubstantial differences test – as its name suggests – the court is charged with determining whether the differences between the claimed invention and the accused product are insubstantial.

Again, Galderma relied on bioequivalence data and its in vitro testing to argue that either DoE test was satisfied. The Federal Circuit was not persuaded, finding no clear error in the district court’s reasoning. As for the function-way-result test, the in vitro testing did not show that Lupin’s ANDA product used the same function or method as the asserted [...]

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What a Croc! False Claim That Product Feature Is Patented Can Give Rise to Lanham Act Violation

The US Court of Appeals for the Federal Circuit reversed and remanded a grant of summary judgment on a false advertising claim, concluding that a cause of action under Section 43(a) of the Lanham Act can arise when a party falsely claims to hold a patent on a product feature and advertises that feature in a misleading way. Crocs, Inc. v. Effervescent, Inc., Case No. 2022-2160 (Fed. Cir. Oct. 3, 2024) (Reyna, Cunningham, JJ.; Albright, District J., sitting by designation).

Crocs, the well-known maker of molded foam footwear, sued several competitor shoe distributors for patent infringement in 2006. The case was stayed pending an action before the International Trade Commission but resumed in 2012 when Croc added competitor U.S.A. Dawgs as a defendant to the district court litigation. The case was stayed twice more, from 2012 to 2016 and 2018 to 2020. In between those stays, in May 2016, Dawgs filed a counterclaim against Crocs and 18 of its current and former officers and directors, alleging false advertising violations of Section 43(a) of the Lanham Act. 15 U.S.C. § 1125(a). The individual defendants were later dismissed from the action.

Dawgs claimed that Crocs deceived consumers and damaged its competitors by falsely describing its molded footwear material, which it calls “Croslite,” as “patented,” “proprietary,” and “exclusive.” Dawgs alleged that it was damaged by Crocs’ false advertisements and commercial misrepresentations because Crocs suggested that its competitors’ footwear material was inferior. Croslite is in fact not patented, as Crocs conceded.

Crocs argued in its motion for summary judgment that Dawgs failed as a matter of law to state a cause of action under Section 43(a) because the alleged advertising statements were directed to a false designation of authorship of the shoe products and not to their nature, characteristics, or qualities, as Section 43(a)(1)(B) requires. The district court agreed. Applying the Supreme Court’s 2003 decision in Dastar Corp. v. Twentieth Century Fox Film Corp. and the Federal Circuit’s 2009 decision in Baden Sports, Inc. v. Molten USA, Inc., the district court granted summary judgment to Crocs. It reasoned that falsely claiming to have “patented” something is similar to a false claim of authorship or inventorship, not to the types of false advertising prohibited by the Lanham Act. Dawgs appealed.

Dawgs argued that the district court’s application of Dastar and Baden to the circumstances of its case was inapposite, and the Federal Circuit agreed. In Dastar, the petitioner copied a television series in the public domain, made minor changes, and sold it as a video set, passing it off as its own. The Supreme Court held that a false claim of authorship does not give rise to a cause of action under the Lanham Act. Similarly, in Baden, the Federal Circuit found that a basketball manufacturer’s false suggestion that it was the author of the “innovative” “dual-cushion technology” in its basketballs did not give rise to a false advertising claim under the Lanham Act.

In this case, however, the Federal Circuit reasoned that Croc’s false [...]

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Creative License: Fair Use Defense Paints Over Infringement Battle

Affirming the application of the fair use defense to copyright infringement, the US Court of Appeals for the Fifth Circuit determined that a district court’s sua sponte invocation of a fair use defense to parallel trademark claims was harmless error. The Court also affirmed that the district court did not abuse its discretion in awarding attorneys’ fees based on the prevailing party standard for copyright claims. Keck v. Mix Creative Learning Ctr., L.L.C., Case No. 23-20188 (5th Cir. Sept. 18, 2024) (Jones, Smith, Ho, JJ.)

Michel Keck, a multimedia artist, sued Mix Creative Learning Center, a Texas-based art studio, for copyright and trademark infringement after Mix Creative sold art kits featuring Keck’s dog-themed artwork and a brief biography, intended for at-home learning during the pandemic. Keck had registered her Dog Art series (in the form of decorative works) with the US Copyright Office and her name as a trademark with the US Patent & Trademark Office. Keck claimed that Mix Creative’s art kits violated her rights. After receiving notice of the lawsuit, Mix Creative promptly ceased selling its kits.

Following discovery, both parties filed cross-motions for summary judgment. The district court granted summary judgment in favor of Mix Creative on Keck’s copyright claim, finding fair use, and also granted summary judgment on the trademark claim sua sponte, as both parties had agreed that the fair use defense applied to both claims. The district court further awarded Mix Creative more than $100,000 in attorneys’ fees and costs, although it declined to hold Keck’s attorneys jointly and severally liable.

Keck appealed, challenging the copyright fair use finding and the district court’s sua sponte application of the fair use defense to the trademark claim. Mix Creative challenged the district court’s refusal to hold Keck’s attorneys jointly and severally liable for fees.

The Fifth Circuit affirmed the district court’s application of the fair use defense to Keck’s copyright claims. The Court focused on the first and fourth factors of the fair use defense (respectively, the purpose and character of the use and the effect of the use on the potential market for or value of the original work), noting that the courts typically give these two factors special attention.

On the first factor, the Fifth Circuit found Mix Creative’s use to be transformative. Although Mix Creative is a commercial enterprise, the art kits served an educational purpose, distinct from the decorative purpose of Keck’s original works. As a result, the likelihood of Mix Creative’s kits serving as a substitute for Keck’s original works in the market was low.

The fourth factor also favored Mix Creative, as the Fifth Circuit found no evidence that Mix Creative’s kits would harm the market value of Keck’s original decorative works. In fact, the Court suggested that the kits might enhance Keck’s reputation and sales by providing her with free advertising. Furthermore, Mix Creative operated in a different market (educational rather than decorative), and Keck had not demonstrated any history of selling derivative works for children’s art lessons. The [...]

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Later-Filed, Earlier-Expiring Patent Not an ODP Reference

Addressing invalidity due to obvious-type double patenting (ODP) based on later-filed-related patents, the US Court of Appeals for the Federal Circuit reversed a district court’s application of In re Cellect (Fed. Cir. 2023) and held that the later-filed, earlier-expiring continuation patents were not available as ODP references against the earlier-filed, later-expiring patent. Allergan USA, Inc. v. MSN Labs Private Ltd., Case No. 24-1061 (Fed. Cir. Aug. 13, 2024) (Lourie, Dyk, Reyna JJ.)

In 2015, the US Food and Drug Administration approved a new drug application for a drug sold by Allergan to treat the symptoms of irritable bowel syndrome. In 2019, Sun Pharma filed an abbreviated new drug application (ANDA) seeking to market a generic version of the drug. Allergan then sued Sun Pharma and MSN Labs for infringement of four patents related to the drug. One of the patents, which claims a compound of the drug, had been granted almost three years of patent term adjustment (PTA) and was followed by two more patents from continuation applications in the same patent family. The other three patents all claimed tablet forms of the drug. The claims of one of the patents recited that a glidant was optional while the claims of the other two patents did not require a glidant at all.

The US District Court for the District of Delaware held a three-day bench trial and concluded that the asserted claim of the compound patent was invalid under the ODP doctrine and that the claims of the three tablet patents were invalid for lack of written description. On the issue of ODP, the district court found Allergan’s “first-filed, first-issued” distinction “immaterial.” The district court stated that “[w]hen analyzing ODP, a court compares patent expiration dates, rather than filing or issuance dates.” Allergan appealed.

The Federal Circuit reversed on both issues. The Court held that the claims of the later-filed, earlier-expiring continuation patents were not available as ODP references against the first patent because the purpose of the ODP doctrine is to prevent patentees from obtaining a second patent to effectively extend the life of the first patent. The Federal Circuit explained that the district court misread Cellect as binding it to solely consider expiration dates in the ODP analysis. The Court explained that Cellect only controls to the extent that it requires a court to consider the later-filed patent’s expiration date (i.e., the expiration date after the addition of PTA) in its ODP analysis, not the expiration date that it would have shared with the reference patents in the absence of a PTA award. The panel majority emphasized that it does not follow that the later-filed patent must be invalidated by the earlier-filed reference patents simply because it expires later. The majority noted that “Cellect does not address, let alone resolve, any variation of the question presented here – namely, under what circumstances can a claim properly serve as an ODP reference – and therefore has little to say on the precise issue before us.”

The Federal Circuit also [...]

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Don’t Mess With Anna: Texas Town Schools Patent Owner on § 101

On cross-appeals from a granted Fed. R. of Civ. Pro. 12(c) motion on subject matter eligibility, the US Court of Appeals for the Federal Circuit found that a patent directed to a method for “assist[ing] an investigator in conducting a background investigation” did not claim patent-eligible subject matter, but that the mere assertion of the patent did not render the case “exceptional” for the purposes of attorneys’ fees. Miller Mendel, Inc. v. City of Anna, Texas, Case No. 22-1753 (Fed. Cir. July 18, 2024) (Moore, C.J.; Cunningham, Stoll, JJ.)

Miller Mendel sued the City of Anna, Texas, for infringement of claims directed to software for managing pre-employment background investigations based on the Anna police department’s use of the Guardian Alliance Technologies (GAT) software platform. Miller Mendel’s complaint asserted “at least claims 1, 5, and 15” of the patent, each of which generally recited a “method for a computing device with a processor and a system memory to assist an investigator in conducting a background investigation” comprising the steps of receiving data identifying the applicant, storing the data, transmitting an applicant hyperlink to the applicant’s email address and receiving an applicant’s response.

Anna moved for judgment on the pleadings, alleging that the patent claims were ineligible for patent protection under 35 U.S.C. § 101. After the district court granted the motion, Miller Mendel filed a motion for reconsideration, arguing that the district court lacked jurisdiction to invalidate any unasserted patent claims. The district court denied the reconsideration motion but clarified that its decision was limited to asserted claims 1, 5 and 15. Anna also filed a motion for attorneys’ fees, which the district court denied, finding that the case was not exceptional. Miller Mendel appealed the § 101 issue, and Anna cross-appealed on the unasserted claims and attorneys’ fees issues.

The Federal Circuit first addressed Miller Mendel’s argument that the district court erred in relying on a declaration filed by Anna in ruling on the Rule 12(c) motion. The Court acknowledged that a Rule 12(c) motion must be treated as one for summary judgment if matters outside the pleadings are presented to and not excluded by the court. However, the district court explained that the declaration was not relevant to its decision, and it did not rely on any material outside the pleadings in its § 101 analysis. Thus, the Federal Circuit found that any error in failing to explicitly exclude the declaration was harmless.

Turning next to the patent eligibility analysis, the Federal Circuit agreed with the district court that under Alice step one, the asserted claims were directed to the abstract idea of performing a background check. The claims and specification emphasized that the invention was a system to “help a background investigator more efficiently and effectively conduct a background investigation” by “automating a majority of the tasks of a common pre-employment background investigation so that fewer hardcopy documents are necessary.” In other words, the problem facing the inventor was the abstract idea of performing background checks more efficiently [...]

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