subject matter eligibility Archives

subject matter eligibility

New Patent Eligibility Bill May Impact What Subject Matter Is Patentable

by Brian J. Malkin | Aug 18, 2022 | Uncategorized

On August 2, 2022, Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act of 2022. Senator Tillis’s bill addresses patent subject matter eligibility by modifying 35 U.S.C. § 101 to mitigate areas in which it has been considered problematic in view of recent judicial decisions/exceptions construing it while retaining its core features. For some in the biotechnology space, “problematic” Supreme Court decisions have included May Collaborative Services (2012), Myriad Genetics (2013), Alice Corp. (2014) and their Federal Circuit progeny.

The core features for eligibility will remain in the statute as: “[w]hoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefore.”

The bill provides express exceptions, including:

A mathematical formula, apart from useful invention or discovery
An unmodified human gene, as that gene exists in the human body
An unmodified natural material, as that material exists in nature.

However, the bill further states that genes or natural material that are “purified, enriched, or otherwise altered by human activity, or otherwise employed in a useful invention or discovery,” would not be considered unmodified and would be eligible for patents. One of the goals of the bill is to override case law that has made it difficult to receive patents on diagnostics inventions and otherwise blurred the line between what inventions are considered abstract.

Processes that are excluded from eligibility under the bill include:

Nontechnological economic, financial, business, social, cultural or artistic processes
Mental processes performed solely in the human mind
Processes occurring in nature wholly independent of, and prior to, any human activity.

Under current law, the question of what constitutes a technological solution that would render an otherwise abstract idea patent eligible is a hotly contested one often determined on a case-by-case basis. The European Patent Convention’s eligibility exclusions include presentations of information and mathematical methods. However, if there is a technical use applied to those types of inventions, they are patent eligible.

The bill was reportedly drafted following three years of work by Senator Tillis’ team, including a series of US Senate hearings in 2019 with Senator Chris Coons (D-DE) and meetings with an array of industries. Updates will be posted to the IP Update blog as legislative developments warrant.

Practice Note: Readers are encouraged to check out the IP Update report that discusses a recent presentation by the PTO that shares recommendations for dealing with § 101 rejections during prosecution, which can be found here.

PTO Presentation Seeks to Clarify Subject Matter Eligibility Requirements

by Amol Parikh | Aug 18, 2022 | Patents

On August 9, 2022, the US Patent & Trademark Office (PTO) gave a public presentation, “Subject Matter Eligibility Under 35 U.S.C. § 101: USPTO Guidance and Policy.” During the presentation, the PTO indicated that its goal is to identify eligible subject matter and not reject patent applications under 35 U.S.C. § 101 where possible. However, subject matter eligibility must be determined in accordance with Supreme Court precedent as set forth in Bilski v. Kappos (2010); Mayo Collaborative Servs. v. Prometheus Labs, Inc. (2012); Association for Molecular Pathology v. Myriad Genetics, Inc. (2013); and Alice Corp. v. CLS Bank International (2014). The PTO presented several biotech examples demonstrating how subject matter ineligible claims could be redrafted to encompass eligible subject matter.

The PTO presented a detailed explanation of the two-step subject matter eligibility flowchart in MPEP § 2106 and emphasized the differences between the two prongs of Step 2A. The first prong is to evaluate whether the claim recites a judicially recognized exception to eligibility. If the claims do not recite an exception, they qualify as eligible subject matter. If the claims do recite a judicial exception, the analysis proceeds to the second prong of Step 2A, which is to evaluate whether the claims recite additional elements that integrate the exception into a practical application of the exception. If the claims do recite additional elements integrating the exception into a practical application of the exception, they qualify as eligible subject matter. If the claims do not do so, the analysis proceeds to Step 2B to determine whether the claims recite additional elements that amount to significantly more than the judicial exception.

While there is significant overlap between Step 2A prong two and Step 2B, the PTO noted that under Step 2A prong two, the additional elements may be well understood, routine, conventional activity, unlike in Step 2B. For example, if conventional steps were used to affect a particular treatment or prophylaxis for a disease or medical condition, or if conventional material was used in an unconventional application, the claims would be subject matter eligible.

The PTO warned against claiming methods as a series of mental processes, mere data gathering or steps that merely apply the judicial exception.

As noted, the PTO highlighted techniques for transforming subject matter ineligible claims into subject matter eligible claims. These techniques include reciting properties that naturally occurring compositions do not possess, showing that the claimed composition possesses properties not found in naturally occurring compositions, using a conventional material or conventional method in an unconventional application and specifying a particular treatment.

Practice Note: Readers may be interested in an IP Update Legislative Alert reporting on a bill introduced by Senator Tillis to amend §101, which can be found here.

Diehr Alice, Yu are Superimposing Novelty onto Patent Eligibility. Love, Newman.

by A. Shane Nichols | Jun 24, 2021 | Patents

The US Court of Appeals for the Federal Circuit affirmed the district court’s grant of a Rule 12(b)(6) motion to dismiss on the basis that, under the two-step Alice analysis, the patent claims—directed to a digital camera—were directed to ineligible subject matter under 35 U.S.C. § 101. Yu, et al. v. Apple Inc., et al., Case Nos. 20-1760; -1803 (Fed. Cir. June 11, 2021) (Prost, J.) (Newman, J., dissenting)

The patent claim under consideration recited an “improved digital camera” that has two lenses, two image sensors, an analog-to-digital converter, a memory and a digital image processor for “producing a resultant digital image from said first digital image enhanced with said second digital image.” Yu conceded that “the idea and practice of using multiple pictures to enhance each other has been known by photographers for over a century” and that the components recited in the claim “are themselves generic and conventional.”

Applying the Supreme Court’s two-step Alice v. CLS Bank test for determining patent eligible subject matter, the Federal Circuit determined at step one that the claim was “directed to the abstract idea of taking two pictures . . . and using one picture to enhance the other in some way.” At step two, the Court held that the claim failed to otherwise define a patent eligible invention because the digital camera “is recited at a high level of generality and merely invokes well-understood, routine, conventional components to apply the abstract idea of [using one picture to enhance the other in some way].” The Court rejected Yu’s attempts to use portions of the patent’s specification to support eligibility, explaining that the eligibility analysis is limited to the literal recitations of the asserted claims.

Then, along came Judge Pauline Newman. With a chainsaw.

In dissent, Judge Newman argued that the majority was improperly enlarging the § 101 analysis to include other “substantive requirements of patentability.” Judge Newman emphasized (twice) that the claim literally recited an electromechanical camera, not an abstract idea. In her view, the camera recited in the claim met the requirements of § 101 as a new and useful machine, without regard to whether the claimed camera also met the novelty requirements of §§ 102 and 103. Referring to the Supreme Court’s 1981 holding in Diamond v. Diehr, Judge Newman wrote that “[i]n contravention of [Diehr‘s] explicit distinction between Section 101 and Section 102, the majority now holds that the [claimed] camera is an abstract idea because the camera’s components were well-known and conventional and perform only their basic functions.” Judge Newman further proclaimed that “the principle that the majority today invokes was long ago discarded.”

Judge Newman also admonished the majority for the destabilizing effects that similar holdings have already had on US patent policy. She noted that “[i]n the current state of Section 101 jurisprudence, inconsistency and unpredictability of adjudication have destabilized technologic development in important fields of commerce,” and that “[t]he fresh uncertainties engendered by the majority’s revision of Section 101 are contrary to the statute and [...]

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Targeted Advertising Still Patent Ineligible Subject Matter

by Paul Devinsky | May 20, 2021 | Patents

The US Court of Appeals for the Federal Circuit found that targeted advertising is still an abstract idea and that a system providing targeted advertising must utilize something more than generic features and routine functions to be eligible for patent protection. Free Stream Media Corp. v. Alphonso Inc., Case No. 19-1506 (Fed. Cir. May 11, 2021) (Reyna, J.)

Free Stream Media, d.b.a. Samba, owns a patent directed to “a system providing a mobile phone user with targeted information (i.e., advertisements) that is deemed relevant to the user based on data gathered from the user’s television.” The system has three main components: (1) a networked device (e.g., a smart TV) that collects primary data, including program information, location, weather information or identification information; (2) a client device (e.g., a mobile device) on which applications run and advertisements may be shown; and (3) a relevancy-matching server that uses the primary data to select advertisement or other targeted data based on a relevancy factor associated with the user. Specifically, the relevancy-matching server “may also be configured to render the targeted data to the user through the networked device and/or the sandboxed application of the client device.”

Samba asserted infringement of the patent against Alphonso. In response, Alphonso filed a motion to dismiss on grounds that the asserted claims of the patent were directed to patent ineligible subject matter under 35 USC § 101. Alphonso subsequently filed a motion for summary judgment of non-infringement. The district court denied the § 101 motion but granted the summary judgment motion. Samba appealed the non-infringement finding, and Alphonso cross-appealed the § 101 finding.

The Federal Circuit started with the § 101 finding by first addressing Alice step 1 (abstract idea). The Court rejected the district court’s finding that the asserted claims were directed to “systems and methods for addressing barriers to certain types of information exchange between various technological devices . . . being used in the same place at the same time,” i.e., to bypass the security sandbox, and not an abstract idea of tailored advertising. To the contrary, the Court found that the asserted claims were directed precisely to the abstract idea of tailored advertising—specifically, gathering information about television users’ viewing habits, matching the information with other content and sending that content to a second device. Reiterating its prior holdings with respect to Alice step 1, the Court explained that the asserted claims only provided for the result of overcoming a security sandbox, and did not at all describe how that result is achieved. The Court also explained that even if the claims did recite a method for bypassing a security sandbox, Samba failed to demonstrate that this was anything more than a mere use of a computer as a tool, or that it somehow “improves the operability of these devices beyond providing a user with targeted content using generic processes and machinery.”

Turning to Alice step 2 (inventive concept), the Federal Circuit explained that the claimed abstract idea of providing targeted advertisements was not [...]

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

by Paul Devinsky | Apr 1, 2021 | Patents

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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New or Not, Object-Oriented Simulation Patent Ineligible Under § 101

by Paul Devinsky | Jan 14, 2021 | Patents

The US Court of Appeals for the Federal Circuit affirmed a district court’s pleadings-stage determination that patent claims directed to an object-oriented simulation were subject matter ineligible under 35 USC § 101. Simio, LLC v. FlexSim Software Prod., Inc., Case No. 20-1171 (Fed. Cir. Dec 29, 2020) (Prost, C.J.).

Simio filed suit against FlexSim for infringement of patent claims directed to object-oriented simulations in which one instance of an object may have behaviors assigned to it without changing the generic object’s definition. FlexSim moved to dismiss the complaint under Fed. R. of Civ. P.12(b)(6), arguing that the patent was invalid under 35 USC § 101. The district court granted FlexSim’s motion to dismiss, finding that the asserted claims were directed to the ineligible abstract idea of substituting text-based coding with graphical processing and that FlexSim properly showed there was no inventive concept or alteration sufficient to make the system patent-eligible. Simio appealed.

The Federal Circuit reviewed the dismissal order and its underlying patent eligibility conclusions de novo. Under the two-step Alice/Mayo framework, the Court affirmed. Considering the first step of the Alice/Mayo framework, the Court agreed that the asserted claims were “directed to the abstract idea of using graphics instead of programming to create object-oriented simulations.” The Court rejected Simio’s argument that the “executable process to add a new behavior to an object instance” improved the functionality of the computer on which it ran, concluding that no improvement was made to the computer and that the claim limitation did not change the claim’s “character as a whole.” As to step two of the Alice/Mayo framework, whether the claim limited the abstract idea to an inventive concept, the Federal Circuit concluded that, while the claim may be directed to a new idea, it is still an abstract one lacking any inventive concept or application of the idea. The Court affirmed the district court’s dismissal.

The Federal Circuit next addressed whether the district court erred in denying Simio’s motion for leave to amend its complaint. The Court concluded that, after disregarding conclusory statements, Simio’s amended complaint just repackaged the same assertions of non-abstractness as the original complaint. Citing its holding in ShoppersChoice.com (IP Update, May 2020), the Court also rejected Simio’s argument that the district court should have conducted claim construction before determining eligibility. In ShoppersChoice.com, the Court held that pleadings-stage patent eligibility decisions may be proper when the patentee does not explain how a term’s construction could affect the analysis.

Finally, the Federal Circuit raised its own independent reasoning for denying Simio’s motion for leave to amend, explaining that it “may affirm on any grounds for which there is a record sufficient to permit conclusions of law, even grounds not relied upon by the district court.” The Court found that Simio failed to show good cause for seeking leave to amend after the scheduling order’s deadline. Namely, Simio’s amended complaint contained no facts that could not have been alleged before the deadline. Nor did Simio demonstrate any relevant [...]

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“Method of Preparation” Claims Still Patent Eligible Under § 101 in Modified Opinion

by Mandy H. Kim | Aug 13, 2020 | Patents

The US Court of Appeals for the Federal Circuit denied an accused infringer’s petition for rehearing en banc and issued a modified opinion with additional analysis maintaining its prior finding that patent claims directed to a method of preparation were patent eligible. Illumina, Inc. v. Ariosa Diagnostics, Inc., Case No. 19-1419 (Fed. Cir. Aug. 3, 2020) (Lourie, J.) (Reyna, J., dissenting).

In its original decision in Illumina v. Ariosa, the Federal Circuit found that claims directed to methods of preparing a fraction of cell-free DNA that is enriched in fetal DNA were not directed to a patent-ineligible natural phenomenon. In its modified opinion, the Court again concluded that the claims were patent eligible under § 101 because they were not directed to a natural phenomenon, but to an exploitation of that natural phenomenon, by inventing a method for preparing a mixture enriched in fetal DNA that selectively removed maternal DNA. In the modified opinion, the majority further explained that the claimed size thresholds were not dictated by any natural phenomenon, but were “human-engineered parameters that optimize the amount of maternal DNA that is removed from the mixture and the amount of fetal DNA that remains in the mixture in order to create an improved end product that is more useful for genetic testing than the original natural extracted blood sample.” The Court emphasized that the claimed methods achieve more than an observation or detection of a natural phenomenon because the claims include “physical process steps that change the composition of the mixture, resulting in a DNA fraction that is different from the naturally occurring fraction in the mother’s blood.” The Court distinguished Myriad by stating that the claims were ineligible in that case because they covered a gene that the inventors isolated but did not invent, whereas in this case, the inventors claimed an innovative method using human-engineered size parameters to perform the separation—not the separated DNA itself. The Court concluded that the claimed methods were patent eligible under § 101 because they “utilize the natural phenomenon that the inventors discovered by employing physical process steps and human-engineered size parameters to selectively remove larger fragments of cell-free DNA and thus enrich a mixture in cell-free fetal DNA.”

Judge Reyna again dissented, arguing that the claims were patent ineligible under § 101 because they were directed to an undisputed natural phenomenon (i.e., the “surprising” discovery of size discrepancy of cff-DNA in a mother’s blood), and the application of the natural phenomenon used routine steps and conventional procedures that are well known in the art. He explained that “[l]ike in Alice, the claims here are directed to a natural phenomenon because they involve a fundamental natural phenomenon, that cff-DNA tends to be shorter than cell-free maternal DNA in a mother’s blood, to produce a ‘mixture’ of naturally-occurring substances.” Judge Reyna argued that the majority ignored the Court’s “claimed advance precedent” by reasoning that the claims belong in a distinct category of “method of preparation” claims, but such characterization should be treated [...]

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Data Processing Software Checks Out as Patent Eligible

by Jodi Benassi | Jan 3, 2020 | Patents

PATENTS / SUBJECT MATTER ELIGIBILITY / ABSTRACT IDEA

Addressing an issue of software subject matter eligibility, the US Court of Appeals for the Federal Circuit reversed the district court’s judgment on the pleadings under 35 USC § 101, finding claims related to error checking patent eligible. Koninklijke KPN N.V. v. Gemalto M2M GMBH et al., Case Nos. 18-1862, -1864, -1865 (Fed. Cir. Nov. 15, 2019) (Chen, J).
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