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10th Circuit Falls into Line on Exceptionality Doctrine in Lanham Act Cases

by | Jun 17, 2021 |

Addressing whether the term “exceptional case” in the Patent Act differs in meaning from the same term used in the Lanham Act, the US Court of Appeals for the 10th Circuit upheld an award of attorneys’ fees granted under a motion filed under 15 U.S.C. 1117(a) and clarified that the exceptional case standard in the Lanham Act parallels the standard in the Patent Act. Derma Pen, LLC v. 4EverYoung Limited, et al., Case No. 19-4114 (10th Cir. June 8, 2021) (Lucero, J.)

In 2013, Derma Pen sued several companies for infringement of the “DERMAPEN” mark. Four years later, Derma Pen was granted a permanent injunction prohibiting the companies and “their officers, agents, servants, employees, attorneys, licensees, and anyone in active concert or participation with, aiding, assisting, or enabling Defendants” from using the mark. A few months later, Derma Pen filed for an order of contempt against one of the defendants, Stene Marshall, alleging that Marshall, with the help of other actors (related parties), had been violating the earlier-issued injunction. During the subsequent proceedings, despite being the plaintiff, Derma Pen routinely failed to meet its discovery obligations, causing the related parties to file as many as six discovery motions and resulting in the imposition of sanctions on Derma Pen.

Following an evidentiary hearing, the district court found Marshall in contempt of the injunction, but concluded that the related parties took no part in Marshall’s violation. Subsequently, the related parties moved for attorneys’ fees incurred in the contempt proceeding under the Lanham Act, 15 U.S.C. 1117(a). The district court granted the motion and awarded more than $190,000 in fees based on application of the “exceptional case” standard set forth in the Supreme Court of the United States’ 2014 decision in Octane Fitness v. Icon Health & Fitness. Specifically, the district court decided that the case was “exceptional” because:

  • Derma Pen produced “no evidence of damages.”
  • “[T]he evidence showed [Derma Pen] had no right to enforce the injunction.”
  • “[T]he evidence showed that [the] trademark was abandoned.”
  • “[M]onetary sanctions were imposed on” Derma Pen for misconduct and delay during discovery.
  • Derma Pen was “entitled to no relief against the [related parties].”

Derma Pen appealed.

The 10th Circuit affirmed the district court’s holding and fees award for the related parties, noting Derma Pen’s misconduct and delay during discovery. In so doing, the Court adopted the Octane Fitness standard as applicable to cases brought under the Lanham Act.

Practice Note: The 10th Circuit noted that it was acting consistently with other circuits that have considered application of the Octane standard to fee disputes under the Lanham Act, citing LHO Chicago River, L.L.C. v. Perillo (7th Cir. 2019) (collecting cases); Xereas v. Heiss (DC Cir. 2021); and Safeway Transit LLC v. Disc. Party Bus, Inc. (8th Cir. 2020).



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IP Ownership Considerations in Multi-jurisdictional Software Development Agreements

by and | Jun 10, 2021 | , , , ,

As a result of the healthcare sector’s growing dependence on software, health IT companies are increasingly taking advantage of globalisation to engage contractors in low wage jurisdictions to develop their user-facing software applications. This can trigger unforeseen legal risks owing to the differing laws across jurisdictions related to the ownership and transfer of intellectual property (IP) rights.

At the most extreme end, best practices in some jurisdictions are unenforceable or even impermissible in others. In view of these issues, it is strongly recommended that a company looking to take advantage of cross-border contracting for critical development eorts should carefully consider the choice of law provisions in their agreements, and engage with local counsel to ensure proper vesting of intellectual property rights.

An inability to demonstrate proper ownership of such rights can be a substantial obstacle for later financings or in corporate activities. Depending on the jurisdictions involved, a contracting company may need to concern itself with at least three types of IP in the software that is developed on its behalf: copyrights, moral or author’s rights, and patents.

Click here to read the full article in our latest edition of International News.



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It’s Highlighted and Verified: Reversal of PTAB Non-Obviousness Decision

by | Jun 3, 2021 |

In a relatively unusual outcome, the US Court of Appeals for the Federal Circuit reversed a Patent Trial & Appeal Board (Board) decision finding non-obviousness in an inter partes review (IPR). Becton, Dickinson, and Co. v. Baxter Corp. Englewood, Case No. 20-1937 (Fed. Cir. May 28, 2021) (Dyk, J.)

Becton petitioned the Board for IPR of Baxter’s pre-America Invents Act (AIA) patent, directed to a system for preparing patient-specific doses and a method for telepharmacy. The Board decided that the patent claims were not shown to be invalid as obvious, but also found that Baxter’s secondary considerations evidence was “weak.” Becton appealed based on two contested limitations: a verification limitation and a highlighting limitation. The Federal Circuit reversed the Board, concluding that the challenged claims were obvious and explained that weak evidence of secondary considerations could not overcome the strong showing of obviousness.

First, the Federal Circuit decided that the Board erred in finding that a prior art reference that taught a remote pharmacist may verify a dose preparation did not render obvious a claimed method where a remote pharmacist must verify. The reference made clear that a non-pharmacist could not further process work without the verification step. Baxter’s own expert witness conceded that, in accordance with the teachings of the prior art, a non-pharmacist would be disciplined for continuing to process dose preparation without authorization. The Court concluded there was no significant difference between the teaching in the prior art reference and Baxter’s verification requirement.

Second, the Federal Circuit decided that the Board erred in finding that the “highlighting” limitation as it relates to a set of drug preparation steps on a computer was non-obvious. In what it characterized as a “close case,” the Board decided that a prior art reference’s teachings highlighting patient characteristics when dispensing repackaged medication did not make obvious highlighting, in a drug formulation context, prompts for additional information. Citing KSR v. Teleflex, the Court explained that the “combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” The reference taught highlighting in terms of various inputs and information delivered. Becton’s expert testified that one of ordinary skill would understand from the reference that other information, such as prescription order information, could be displayed on the user interface. Baxter’s expert did not contradict Becton’s expert. Because “a person of ordinary skill is also a person of ordinary creativity, not an automaton,” the Board erred in using that one reference as the only source for what one of ordinary skill would consider.

Lastly, Baxter unsuccessfully argued that under pre-AIA 35 U.S.C. § 102(e)(2), one of the patent references was ineligible as prior art. Sec. 102(e)(2) provides that a prior art reference may be a “patent granted” on another’s application filed in the United States before the invention by the applicant. Baxter argued that since the claims of the reference were cancelled after a 2018 IPR, the reference no longer qualified as a “patent granted” [...]

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Full Scope of Claimed Invention Must Be Enabled

by | May 20, 2021 |

In a case relating to nucleic acid sequencing, the US Court of Appeals for the Federal Circuit upheld a jury verdict of non-enablement because a skilled artisan would have only known how to successfully practice a narrow range of the full scope of the nucleic acids covered by the asserted claim at the time of the invention. Pacific Biosciences of California, Inc. v. Oxford Nanopore Technologies, Case No. 21-2155, -2156 (Fed. Cir. May 11, 2021) (Taranto, J.)

PacBio sued Oxford for infringement of two patents related to methods for sequencing nucleic acids (such as DNA) using nanopore technology. The methods involve drawing nucleic acids through a nanometer-sized hole formed in a substrate. A voltage is applied to the substrate, and as the nucleic acids pass through the hole, the identity of each nucleic acid is identified based on changes in electric current passing through the substrate.

At trial, Oxford’s lawyer made opening remarks that included references to the potential applications of Oxford’s accused products to the then-emerging global COVID-19 crisis. PacBio immediately objected, and the district court gave exactly the curative instruction that PacBio requested. The district court also required that going forward, the parties give advance notice if they intended to make any reference to COVID-19. Ultimately, the jury found all asserted claims infringed, but also determined that the claims were invalid for lack of enablement under 35 USC § 112. In post-trial motions, the district court denied PacBio’s request that the court grant a new trial because of Oxford’s remark during opening statements regarding the accused products’ potential application to the then-emerging COVID-19 crisis. PacBio appealed.

On appeal, PacBio argued that the jury’s finding of lack of enablement was unsupported by the evidence, citing to testimony from its expert that a person skilled in the art at the priority date would have been able to successfully perform the methods of the asserted claims. The Federal Circuit disagreed, noting that the expert only demonstrated successful practice of the asserted claims for a narrow subset of nucleic acids covered by the claims—namely DNA hairpin molecules. The Court cited evidence where PacBio admitted through a stipulation that it had never performed the nanopore sequencing methods of the asserted claims, meaning its reduction to practice was purely constructive. The Court also noted that Oxford produced evidence that it was not until 2011 (two years after the priority date) that anyone in the field was able to use nanopore sequencing to sequence biological DNA—a different type of nucleic acid within the scope of the asserted claims. Thus, the Court found that PacBio had only demonstrated that a person of skill in the art would have been able to successfully practice a narrow range of the full scope of the nucleic acids covered by the asserted claim. The Court explained that it is not enough for enablement that the relevant artisans knew how to perform some nanopore sequencing before the priority date. Instead, what matters is the scope of the asserted claims, which relate [...]

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Use is ACTUALLY Measured by Benefit

by | May 13, 2021 |

Addressing whether a service mark owner had established a protectable interest in his marks through actual or analogous use, the US Court of Appeals for the 10th Circuit reversed in part the district court’s grant of summary judgment for the alleged infringer, explaining that by focusing on sales, the district court applied the wrong legal standard for analyzing actual use. Underwood v. Bank of Am. Corp., Case Nos. 19-1349, 20-1087 (10th Cir. Apr. 30, 2021) (Matheson, J.)

In 2010, Erik Underwood and My24HourNews.com (collectively, Underwood) applied for, and were granted, registration of a service mark in Georgia for a computer-animated woman named Erica who verbally reports the news through cell phones and computer programs. In 2012, Underwood registered the domain name for a website, my24erica.com. On the website, E.R.I.C.A. could answer questions and offer recommendations regarding movies and television shows. In 2016, Bank of America filed an intent to use application with the US Patent and Trademark Office for ERICA, a mark for goods and services including voice-controlled information, personal assistant banking and finance services. Underwood sued Bank of America, alleging common law service mark infringement of two marks, E.R.I.C.A. and my24erica.com.

The district court granted summary judgment for Bank of America, concluding that Underwood had not established a protectable interest in either of the marks through actual or analogous use. Underwood appealed.

The 10th Circuit concluded that the district court applied the wrong legal standard and committed two legal errors in its analysis of the issue of actual use of the E.R.I.C.A. mark. First, the district court erred by assuming that in order to establish actual use, Underwood’s customers must have purchased the services offered or Underwood must have generated revenue, because actual use is measured by benefit—not sales to third parties. Second, the district court erred by limiting the services at issue to those listed on the Georgia registration (i.e., newscasting). Instead, the district court should have considered all services identified by the mark, including those on the my24erica.com website (i.e., search engine and personal assistant services). The Court remanded the issue of actual use to permit the district court to address the factual issues under the correct legal standard.

Analogous use of a mark is use in commerce that is non-transactional, e.g., promotional efforts for the goods or services, such as advertising brochures, catalogs, newspaper ads, and articles in newspapers and trade publications. Although actual use need not have a substantial impact on the purchasing public, analogous use must be “of such a nature and extent as to create public identification of the target term with the [user’s] product or service.” To qualify as analogous use, the use must be open and notorious, i.e., “of such a nature and extent that the mark has become popularized in the public mind so that the relevant segment of the public identifies the marked goods with the mark’s adopter.” Because the analogous use in terms of the E.R.I.C.A. mark had large gaps in time; consisted only of PowerPoint presentations at [...]

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Tax Court Allows Partial Deduction, Requires Partial Capitalization of Generic Drug Approval Legal Expenses

by | May 13, 2021 |

The US Tax Court determined that a pharmaceutical manufacturer’s legal expenses incurred to defend against a patent infringement suit were eligible for an immediate deduction as ordinary and necessary business expenses, while legal expenses incurred as part of an abbreviated new drug application (ANDA) were not eligible for an immediate deduction and thus had to be capitalized and then amortized over 15 years. Mylan, Inc. & Subsidiaries v. Commissioner, 156 T.C. No. 10 (Apr. 27, 2021) (Urda, J.)

The ANDA process allows for faster approval of a generic drug if the manufacturer can show that the generic drug is sufficiently similar to an approved brand name drug. As part of the ANDA process, the generic manufacturer must file statements certifying that the generic drug does not infringe any brand drug patents, or that such patents are invalid. The generic manufacturer also must send a notification to the holder of any patents covered by the certification statements.

Mylan filed several ANDAs for generic versions of brand name drugs, including Celebrex, Lunesta and Nexium, during the tax years at issue in the case. Considerable legal expenses were incurred as part of filing the ANDAs and making the required certifications and notifications. As a result of those certifications and notifications, patent holders brought approximately 120 patent infringement suits against Mylan. Mylan defended itself against the infringement suits, incurring litigation expenses.

In general, taxpayers may take an immediate deduction for ordinary and necessary business expenses. However, taxpayers must capitalize expenditures that create or enhance a distinct asset or otherwise generate benefits for taxpayers beyond a single tax year. Special rules apply to determine whether expenses related to an intangible asset should be capitalized. The income tax regulations provide that a “taxpayer must capitalize amounts paid to a governmental agency to obtain, renew, renegotiate, or upgrade its rights under a trademark, trade name, copyright, license, permit, franchise, or other similar right granted by that governmental agency.” Taxpayers must also capitalize an amount paid to facilitate an acquisition or creation of an intangible.

Litigation expenses for patent suits may be deducted or must be capitalized depending on the nature of the litigation. Defense of title claims are treated as the acquisition or disposition of a capital asset and must be capitalized. In contrast, patent infringement claims arise in tort and can be deducted in the year the expense is incurred.

Applying these rules to Mylan’s legal expenses, the Tax Court held that expenses related to the preparation of the ANDA, including the certifications and notices, were capital expenses to acquire or create an intangible asset and had to be recovered incrementally over 15 years. However, the Tax Court held that the costs of defending against patent infringement suits is an ordinary and necessary business expense for a generic drug manufacturer and permitted Mylan to deduct its litigation expenses in the year the expense was incurred.



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Set Phase to Subject Matter Ineligible: More Accurate Haplotype Phase Method Still Abstract

by | Apr 1, 2021 |

In an appeal from a final rejection of a pending application, the US Court of Appeals for the Federal Circuit held that claims directed to methods for determining “haplotype phase” were correctly rejected as subject matter ineligible. In Re: Board of Trustees of The Leland Stanford Junior University, Case No. 20-1288 (Fed. Cir. Mar. 11, 2021) (Reyna, J.)

This case was consolidated for the purposes of oral argument with In Re: The Board of Trustees of the Leland Stanford Junior University, Case No. 20-1012 (Stanford Part I). Both cases relate to methods of determining “haplotype phase” (a scientific way of describing the methodology for determining from which parent a particular allele (or gene) is inherited).

Stanford Part I related to a claimed method that utilized “linkage disequilibrium data” and “transition probability data” to increase the number of haplotype predictions made. In Stanford Part I, the Federal Circuit held that this claimed method for increasing the number of haplotype predictions made did nothing more than recite a haplotype phase algorithm and instruct users to “apply it,” similar to the claimed subject matter prohibited by Alice.

The claims at issue in this appeal were directed toward a method of improving the accuracy and efficiency of haplotype predictions, which involves “building a data structure describing a Hidden Markov Model,” and then “repeatedly randomly modifying at least one of the imputed initial haplotype phases” to automatically recompute the parameters of the Hidden Markov Model until the parameters indicate that the most likely haplotype phase is found. In addition to these mathematical steps, the claims recited the steps of receiving genotype data, imputing an initial haplotype phase, extracting the final predicted haplotype phase from the data structure and storing it in computer memory.

The examiner and then the Patent Trial & Appeal Board found that this claimed improved process was directed toward patent-eligible subject matter—a mathematical algorithm. Stanford appealed.

Applying the two-step Alice framework, the Federal Circuit first determined whether the claims were directed to an abstract mathematical calculation and thus directed to patent-ineligible subject matter under 35 USC § 101.

Stanford argued that the claimed process was not directed to a patent-ineligible abstract idea, but instead represented an improvement on a technological process—namely, an improvement in the efficiency of haplotype phase predictions that this mathematical algorithm could yield. The Federal Circuit found that Stanford had forfeited this argument by failing to raise it before the Board.

Stanford separately argued that another claimed advantage was that the claim steps resulted in more accurate haplotype predictions, rendering the claimed invention a practical application rather than an abstract idea. The Federal Circuit disagreed, explaining that the improvement in computational accuracy alleged here did not qualify as an improvement to a technological process, but rather was an enhancement to the abstract mathematical calculation of haplotype phase itself.

Next, under step two of the Alice inquiry, the Federal Circuit found that the claims did not include additional limitations that, when taken as a whole, provided an [...]

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No Estoppel in the Name of Different Interests and Claims

by | Mar 17, 2021 |

The US Court of Appeals for the Federal Circuit found that 35 USC § 314(d) did not bar its review of a Patent Trial & Appeal Board determination that a petitioner was not estopped from maintaining inter partes review (IPR) proceedings since the alleged estoppel-triggering event occurred post-institution. Uniloc 2017 LLC v. Facebook Inc., Case Nos. 19-1688, -1689 (Fed. Cir. Mar. 9, 2021) (Chen, J.)

Facebook and WhatsApp (collectively, Facebook) filed two IPR proceedings challenging certain claims of Uniloc’s patents. Apple also filed a petition challenging a subset of claims of the patent. Facebook subsequently filed a third petition that was substantively identical to Apple’s petition and also filed a motion to join Apple’s IPR. LG Electronics filed petitions identical to Facebook’s three petitions and also filed motions to join Facebook’s IPRs. The Board instituted Facebook’s third petition and granted Facebook’s motion to join Apple’s IPR. The Board then instituted Facebook’s original IPRs and ordered the parties to “brief the applicability, if any, of 35 U.S.C. § 315(e)(1)” against Facebook, in light of the soon-to-be-issued final written decision for Apple’s IPR. At the time, LG’s petition and motion to join Facebook’s IPRs had not been decided.

In response to the Board’s order, Facebook argued that it should not be estopped under § 315 from challenging the patentability of any claim upon the issuance of a final written decision in Apple’s IPR. Facebook argued that if the Board did find it estopped, Facebook should be able to continue as a petitioner against one of the claims, which it never challenged, in Apple’s IPR. Facebook also argued that if LG’s IPR petition was granted and LG was joined as a party to its first IPR, the IPR should proceed as to all challenged claims (regardless of whether Facebook was found estopped) because LG was not a party in Apple’s IPR. Uniloc responded, arguing that once the Board issued a final written decision in Apple’s IPR, Facebook would be estopped as to all claims challenged in its first IPR and the Board must terminate that proceeding. Uniloc also argued that allowing LG to join the IPR would create inefficiency and confusion.

The Board ultimately instituted LG’s IPR petitions and granted LG’s motion to join Facebook’s IPRs. In its Patent Owner Responses to the original Facebook IPR petitions, Uniloc argued that LG should be barred from maintaining the first Facebook IPR once the Board issued a final written decision in the Apple IPR because LG was estopped as a real party in interest (RPI) or privy to Facebook. A few months later, the Board issued a final written decision in the Apple IPR upholding the patentability of all challenged claims. The Board’s decision in the first Facebook IPR found that Facebook was estopped under § 315(e)(1) as to claims also challenged in Apple’s IPR, but not other claims since § 315(e)(1)’s estoppel provisions apply only to grounds that the petitioner raised or reasonably could have raised “with respect to that claim.”

In its final [...]

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Method for Determining Haplotype Phase Found Subject Matter Ineligible

by | Mar 17, 2021 |

In an appeal from a final rejection of a pending application, the US Court of Appeals for the Federal Circuit held that claims directed to methods for determining “haplotype phase” were correctly rejected under 35 USC § 101 as subject matter ineligible. In Re Board of Trustees of The Leland Stanford Junior University, Case No. 20-1012 (Fed. Cir. Mar. 11, 2021) (Reyna, J.)

Haplotype phase is a scientific way of describing the methodology of determining from which parent a particular allele (or gene) is inherited. The representative claim involved (i) receiving allele data, (ii) receiving pedigree data, (iii) determining an inheritance state based on the allele data, (iv) receiving transition probability data; (v) receiving linkage disequilibrium data and then- determining a haplotype phase based on the pedigree data, the inheritance state for the information described in the allele data, the transition probability data and the population linkage disequilibrium data; and storing the haplotype phase in a computer system and providing the stored haplotype phase in response to a request.

Steps (i) through (iii) were known in the art for determining haplotype phase. The crux of the improved process depended on steps (iv) and (v). The additional data provided as “linkage disequilibrium data” and “transition probability data” allegedly enable haplotype phase to be inferred in regions of the gene where “inheritance state” may be uninformative. The additional data in the claimed method resulted in an increase in the number of haplotype phase predictions made.

The examiner, and then the Patent Trial & Appeal Board, found that the claimed process was directed toward patent eligible subject matter—a mathematical algorithm. Stanford appealed.

Applying the two-step framework established by the 2014 Supreme Court decision in Alice Corp. v. CLS Bank, the Federal Circuit first determined that the claims were directed to an abstract mathematical calculation under Alice step one.

Under step two of the Alice inquiry, the Federal Circuit found that the claims did not include additional limitations that, taken as a whole, provide an inventive concept that transforms the abstract idea into patent eligible subject matter. The Court reasoned that the representative claim “recites no steps that practically apply the claimed mathematical algorithm; instead [the claim] ends at storing the haplotype phase and ‘providing’ it ‘in response to a request.'” These steps alone were not enough to transform the abstract idea into patent eligible subject matter.

Stanford argued that the claimed process was directed to patent eligible subject matter and represented an improvement on a technological process—namely, an improvement in the number of haplotype phase predictions that this mathematical algorithm could yield. The Federal Circuit was unpersuaded that the pending claims did anything other than “merely enhance[] an ineligible concept.”

The Federal Circuit concluded that the claims only recited the conventional haplotype phase algorithm and then instruct: “apply it,” similar to the claimed subject matter prohibited by the Supreme Court in Alice. Accordingly, the Court affirmed the Board’s decision.



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Corresponding Structure Necessary to Support ‘Module’ Claim Element

by | Mar 11, 2021 |

In determining whether a claim element invoked 35 USC § 112, ¶ 6, the US Court of Appeals for the Federal Circuit concluded that “module” was a nonce term and required sufficient corresponding structure in the patent specification to avoid indefiniteness under 35 USC § 112, ¶ 2. Rain Computing, Inc. v. Samsung Electronics Co., Ltd., Case Nos. 20-1646, -1656 (Fed. Cir. Mar. 2, 2021) (Moore, J.)

Rain sued Samsung for infringement of a patent directed to a method for delivering software application packages to user terminals over a network. The claims at issue included an element that recited a “user identification module configured to control access [to] software application packages.” The district court determined that the “user identification module” was a means-plus-function term subject to 35 USC § 112, ¶ 6, but that the specification disclosed sufficient corresponding structure such that the term was not indefinite. Rain appealed the judgment of non-infringement.

Reviewing de novo, the Federal Circuit first addressed whether the claim language invoked § 112, ¶ 6. While there is a rebuttable presumption that ¶ 6 does not apply to claims lacking “means” language, the Court noted that “module” does not provide any indication of structure and is a well-known substitute for “means.” No other claim language, including the “user identification” prefix, imparted any structure onto the term. For purposes of claim construction, the specification also did not impart any structure to the claimed user identification module. Rain argued that amendments and examiner arguments during prosecution were proof of sufficient structure, and that, as the examiner noted, a means-plus-function term cannot be nested within a method claim. The Federal Circuit disagreed, noting that the examiner’s statement that a means-plus-function claim element cannot be nested within a method step was simply incorrect as a matter of law. Thus the Court found that “user identification module” was a means-plus-function claim term.

Citing to its 2015 en banc ruling in Williamson v. Citrix Online, the Court turned to the term’s construction under §112, ¶ 6, applying the same two-step process it used just a few weeks earlier in Synchronoss Technologies v. Dropbox. In the first step, the Court simply used the district court’s undisputed finding that the function was “to control access to . . . software packages to which the user has a subscription.” In the second step, the Court attempted to identify corresponding structure in the specification. Here the Court noted that structure in a specification corresponds only if there is a clear link or association, and that the specification must also disclose an actual algorithm when the function is performed by a general-purpose computer.

The Federal Circuit concluded that the district court erred in finding that the disclosure of a storage device provided sufficient structure, explaining that such devices are nothing more than general purpose computers not capable of performing the access control function without specialized software—an algorithm. Rain’s patent specification disclosed no such algorithm, without which the “user identification module” lacked sufficient structure. Thus [...]

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