Posts Tagged: "patentable subject matter"

Rethinking the Way We Patent Diagnostics

The 2012 Supreme Court decision in Mayo Collaborative Servs. v. Prometheus Labs changed the landscape for patenting diagnostic inventions in the United States. Patent eligibility/ineligibility in the United States stems from two sources: (1) 35 U.S.C. § 101, and (2) judicially-created exclusions, including laws of nature, natural phenomena, abstract ideas, and mental processes. In Mayo, the Supreme Court struck down method of treatment claims for being directed to a law of nature. While Mayo did not create this exclusion, it significantly expanded its applicability to diagnostic-based inventions. This paper explores Federal Circuit case law on patent eligibility of diagnostic-based inventions since the Mayo decision, as well as provides practical guidance on drafting diagnostic patent claims in light of these decisions.

Strong Roots: Comparative Analysis of Patent Protection for Plants and Animals

Much has been written about the uncertainty in U.S. patent law concerning laws of nature, natural phenomena, and abstract ideas following the Supreme Court’s decisions in Mayo v. Prometheus and Alice Corp Pty Ltd v. CLS Bank Int’l. A recent decision from the Enlarged Board of Appeal at the European Patent Office (the Enlarged Board), however, demonstrates that the United States is not alone in grappling with issues surrounding patent eligibility. In the case of genetically modified plants and animals, questions arise on where to draw the line between human invention and biological processes. Earlier this year, the Enlarged Board reversed a 2015 decision that had held that product-by-process patents could be sought for genetically modified plants and animals despite a patent exclusion for “essentially biological processes.” 

Illumina v. Ariosa: En Banc Rehearing Denied, Illumina Patents Again Upheld on Rehearing

On August 3, the United States Court of Appeals for the Federal Circuit (CAFC) denied a petition for rehearing en banc and issued a modified opinion, following a petition for rehearing filed by Ariosa in Illumina, Inc. v. Ariosa Diagnostics, Inc. Sticking closely to the reasoning of its March opinion, the CAFC reversed a decision by the United States District Court for the Northern District of California that claims of U.S. Patent Nos. 9,580,751 (the ’751 patent) and 9,738,931 (the ’931 patent) belonging to Sequenom and Illumina (Illumina) were invalid under 35 U.S.C. § 101 as being directed to an ineligible natural phenomenon.

CAFC Evenly Splits on En Banc Rehearing of American Axle’s Driveshaft Patent Case

On Friday, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued Orders granting a request for panel rehearing and denying a request for rehearing en banc in response to a joint petition filed by American Axle & Manufacturing (AAM). The CAFC also issued a precedential modified opinion of its October 3, 2019 opinion in American Axle & Manufacturing v. Neapco Holdings. In the Order Denying Rehearing En Banc, Judges Newman, Moore, O’Malley, Reyna, Lourie and Stoll dissented from the denial of rehearing en banc. Each of Dyk, Chen, Newman, Stoll and O’Malley wrote separately.

Federal Circuit Affirms District Court’s Eligibility Analysis, Reyna Dissents

On July 14, the United States Court of Appeals for the Federal Circuit, with Judge Lourie writing for the majority, affirmed-in-part and vacated-in-part a decision of the United States District Court for the Eastern District of Texas in Packet Intelligence, LLC v. NetScout Systems, Inc. The CAFC affirmed the district court’s judgments on the issues of infringement, invalidity, and willfulness, but reversed with respect to pre-suit damages. Judge Reyna wrote separately, dissenting on the issue of patent eligibility under Section 101.

CAFC Decision in CardioNet Should Make More Accurate Diagnostics Patentable

A strategy for the COVID-19 pandemic is testing for antibodies to determine possible immunity. Such diagnostic tests may suffer from a high false positive rate. Improving accuracy is therefore desirable. However, the U.S. Patent and Trademark Office (USPTO) is generally not receptive to diagnostic claims that improve accuracy. The recent case of CardioNet v. Infobionic, makes patenting more accurate diagnostics easier. CardioNet considered whether a more accurate cardiac monitoring device was eligible. Claim 1 recites a device that detects abnormal heart rhythms (atrial fibrillation or atrial flutter) in a patient. The district court held that the claims were directed to an abstract idea of identifying atrial fibrillation or atrial flutter “by looking at the variability in time between heartbeats and taking into account ventricular beats.” The Federal Circuit reversed and held an improved cardiac monitoring device was not an abstract idea.

Amici Implore Supreme Court to Take Up Chamberlain Petition

Two amicus briefs have now been filed in The Chamberlain Group’s bid to the Supreme Court for review of “whether the Federal Circuit improperly expanded § 101’s narrow implicit exceptions by failing to properly assess Chamberlain’s claims ‘as a whole.’” Former Federal Circuit Chief Judge Randall Rader has submitted a joint brief with Chargepoint, Inc.—which recently lost its own plea to the High Court to fix Section 101 law—and High 5 Games submitted a separate brief. Both are backing the petition and urging the Court to resolve the uncertainty around U.S. patent eligibility law once and for all, and sooner rather than later.

An Emerging Section 101 Expansion to Section 112(a) Enablement? The Federal Circuit Should Stop It Now

The most dominant, divisive issue in patent law over the last decade—Section101-eligibility and the Supreme Court’s Mayo-Alice framework—appears to have just become more divisive. Indeed, at least part of the reason for the controversy is that, with Mayo-Alice as the governing test, courts as a preliminary matter can decide Section101-eligibility based on considerations of an “inventive concept” and patentability—issues the Court once declared were “not relevant” to the separate eligibility provision of the Patent Act. Be that as it may, the Federal Circuit has recently issued certain decisions indicating that Section 101 now incorporates another vast area of invalidity; viz., the requirements for “enablement” under 35 U.S.C. §112(a). See, e.g., Customedia Technologies, LLC v. Dish Network Corp., 951 F.3d 1359, 1365-66 (Fed. Cir. March 6, 2020). In this article, we examine how this new requirement for Section 101 has emerged, the recent precedent on the issue, and the Patent Act’s requirements that undermine such Section 112(a) considerations for a Section 101-eligibilty test.

Lessons on Patent Subject Matter Eligibility from Dropbox v. Synchronoss

Since the Supreme Court decided Alice Corporation Pty. Ltd. v. CLS Bank International et al. on June 19, 2014, the number of patent application rejections by the U.S. Patent and Trademark Office (USPTO), the number of cases in the courts, and the uncertainty about whether an issued patent will hold up in court over an inquiry into patent subject matter eligibility under 35 U.S.C. §101 have all increased. Dropbox, Inc., Orcinus Holdings, LLC, v. Synchronoss Technologies, Inc., decided June 19, 2020, is a relevant recent (albeit nonprecedential) ruling by the United States Court of Appeals for the Federal Circuit that serves as a useful case study on what worked and went well and what didn’t for both plaintiff and defendant in a Section 101 case. At issue was the eligibility of Dropbox patents U.S. 6,178,505, U.S. 6,058,399 and U.S. 7,567,541.

District Court Finds Palomar’s ‘Pick and Place’ Patent Invalid Under 101

In a follow-up to a decision earlier this month blocking an attempt by Palomar Technologies, Inc. to bar new prior art references based on IPR estoppel, the U.S. District Court for the District of Massachusetts on May 28 has now granted a motion for summary judgment by MRSI Systems, LLC (MRSI), holding U.S. Patent No. 6,776,327 invalid under 35 U.S.C. § 101 as being directed to a patent-ineligible abstract idea. The district court concluded that the ’327 Patent was directed to the abstract idea of placing an item at an intermediate location before moving it to a final one in order to increase the accuracy of the final placement and is applicable to an ‘almost infinite breadth of applications.

Chamberlain Petitions SCOTUS to Review CAFC’s ‘Refusal to Assess Claims as a Whole’ in Garage Door Opener Case

On May 15, the Chamberlain Group Inc. filed a petition for a writ of certiorari asking the U.S. Supreme Court to review the U.S. Court of Appeals for the Federal Circuit’s (CAFC) decision reversing a district court’s holding that Chamberlain’s claims covering a “moveable barrier operator” were patent-eligible under Section 101. If the Supreme Court grants review, it will consider whether the Federal Circuit “improperly expanded § 101’s narrow implicit exceptions by failing to properly assess Chamberlain’s claims ‘as a whole,’ where the claims recite an improvement to a machine and leave ample room for other inventors to apply any underlying abstract principles in different ways.”

Illumina v. Ariosa Diagnostics: A Closer Look

The Federal Circuit recently found that a method for preparing an extracellular DNA fraction from a pregnant human female and using it for analyzing a genetic locus involved in a fetal chromosomal aberration was not directed to a natural phenomenon, and thus eligible for patenting. Illumina, Inc. v. Ariosa Diagnostics, Inc., No. 2019-1419 (Fed. Cir. March 17, 2020) (“Illumina v. Ariosa”). The decision includes a dissent. Appreciation of the reasoning of both the Majority and the Dissent is essential to understanding the current state of the debate on subject matter eligibility of processes involving natural phenomenon. The all-important question in such cases centers on how to determine whether such an invention is directed to a judicial exception. Stated differently, when does an invention that uses a natural phenomenon turn into a patent-eligible process rather than being directed merely to the natural phenomenon?

Flaws in the Supreme Court’s §101 Precedent and Available Ways to Correct Them

Amid the crush of patent-eligibility case law, see 35 U.S.C. §101, patent lawyers and even courts can lose sight of the key principles and precedents that serve as the foundation of the eligibility analysis. Or they may not have appreciated in the first place the underlying bases for these §101 cases and whether, for example, those cases accord with precedents they cite from decades before. In any event, this article addresses these foundational Supreme Court precedents for §101 and the Mayo-Alice ineligibility regime that dominates the patent landscape today. In particular, we trace the Court’s precedents from nearly 50 years ago, with an emphasis on key cases separated by some 30 years but tied together by the Court’s representation that it has faithfully followed (and not overruled) any such precedent. After analyzing the precedent in this light, with due emphasis on the Supreme Court’s decisions in Diamond v. Diehr, 450 U.S. 175 (1981) and Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012), the article briefly examines the U.S. Patent and Trademark Office’s 2019 Patent Eligibility Guidance on §101—the Article II branch’s response to the §101 sea change wrought by the Article III courts. Finally, based on these authorities, the article offers a mix of points and observations for patent litigators and judges to consider as they continue to shape §101’s eligibility law.

The Long Reach of the Mathematics Patentability Exception is Overbroad and Absurd – Part 1

The mathematics exception for subject matter eligibility is overbroad because it was improperly justified under the premise that mathematics is like a law of nature. This is absurd because mathematics is everywhere, and excepting mathematics means excepting virtually everything. Recent court decisions declare that “[m]athematical calculations and formulas are not patent eligible,” SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161 (2018)(“SAP AM.”), based on older decisions, such as Parker v. Flook, 437 U.S. 584 (1978) (“Flook”) and Gottschalk v. Benson, 409 U.S. 63 (1972) (“Benson”).

The USPTO’s Update on Subject Matter Eligibility of October 2019 (“OCT2019 PEG”) states, “The 2019 PEG defines ‘mathematical concepts’ as mathematical relationships, mathematical formulas or equations, and mathematical calculations,” and “where a formula or equation is written in text format that should also be considered as falling within this grouping.” This means that one can have a mathematical concept without even writing any mathematics. The USPTO can assert this illogical and absurd statement because the justification for the underlying mathematical exception itself is also illogical and absurd.

Study Suggests Individuals and Startups More Likely to Face Invalidity Under Alice

To the surprise of Lemley and Zyontz, their study uncovered a striking disparate treatment in the way federal courts handle patent eligibility matters based on entity size, with startup companies doing poorly when it comes to Alice-related patent eligibility matters, and individual inventors doing even worse. Their abstract summarizes their findings thusly: “Most surprisingly we find that the entities most likely to lose their patents at this stage are not patent trolls but individual inventors and inventor-started companies,” Lemley and Zyontz write. “As biotech worries about deterrence of new innovation and software worries about patent trolls dominate the debates, we may be ignoring some of the most important effects of Alice.”