Michael Stein

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Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part III

Legislative Exclusions of Software (21st Century Cures Act) The 21st Century Cures Act (Cures Act), signed into law on Dec. 13, 2016, was designed to accelerate medical product development and bring new innovations faster and more efficiently to patients who need them. Interesting aspects of the Cures Act include that it streamlines FDA procedures to … Continue Reading

CAFC: Patents Enjoy a Presumption of Subject Matter Eligibility

In Cellspin Soft, Inc. v. Fitbit, Inc.,[1] the Court of Appeals for the Federal Circuit (CAFC) rendered an important decision declaring that the presumption of validity under § 282 includes the presumption that claims are patent eligible under § 101. Claimed Invention and Procedural Posture Cellspin sued several companies for infringing various claims of four … Continue Reading

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part II

The Promise of Digital Therapeutics According to Wikipedia, digital therapeutics can be defined as a treatment or therapy that utilizes digital health technologies to spur changes in patient behavior. The first mention of the term in a peer-reviewed research publication was in 2015, in which Dr. Sepah et al. defined “digital therapeutics” as “evidence-based behavioral … Continue Reading

Risks and Rewards of Digital Therapeutics in Treating Mental Disorders – Part I

Introduction More Americans than ever before are suffering from mental and emotional distress. In the United States, the mental health problem is exacerbated by issues across infrastructure, government and culture. However, because the resources for those living with mental health issues are constrained,[1] startups could have a big impact. In particular, we believe that digital … Continue Reading

The ‘Integrated Into a Practical Application’ Test of the 2019 Revised Patent Subject Matter Eligibility Guidance

On Jan. 4, 2019, the USPTO announced revised guidance relevant to Section 101 rejections (“2019 Revised Patent Subject Matter Eligibility Guidance”). The 2019 Revised Patent Subject Matter Eligibility Guidance explains that a claim that recites a judicial exception is not “directed to” the judicial exception if the judicial exception is “integrated into a practical application” … Continue Reading

Finjan v. Blue Coat Systems: Attaching Security Profile to a Downloadable Is Patent Eligible

In Finjan v. Blue Coat Systems, the Court of Appeals for the Federal Circuit rendered a decision containing interesting rulings on patentable subject matter (affirming the District Court determination that certain claims were patent eligible) and reasonable royalty damages (vacating part of a jury verdict for failure to adequately apportion the royalty base). This article … Continue Reading

Visual Memory v. NVIDIA: The Importance of a Robust Written Description

Introduction In Visual Memory v. NVIDIA (Fed. Cir. 2017), the Federal Circuit reversed the district court’s holding that Visual Memory’s U.S. Patent No. 5,953,740 is drawn to patent-ineligible subject matter. Instead, the court ruled that the ’740 patent claims an improvement to computer memory systems and is not directed to an abstract idea. The ’740 Patent … Continue Reading

USPTO Report on Patent Eligible Subject Matter

  On July 25, the USPTO published a new report titled “Patent Eligible Subject Matter: Report on Views and Recommendations From the Public.” The report attempts to synthesize public comments on the appropriate boundaries of patent eligible subject matter. The report includes a section reviewing the historical development of patent subject matter eligibility in the … Continue Reading

Patent Exhaustion Case Could Have Enormous Impact on Multinational Businesses

Earlier this year, the Federal Circuit ruled en banc in Lexmark v. Impression,[1] the most significant exhaustion ruling since the Supreme Court’s Quanta decision.[2] In response to Impression’s cert. petition, the Supreme Court called for the views of the Solicitor General. The U.S. has now filed its brief, recommending cert. be granted on both questions. … Continue Reading

CAFC Hands Down Significant § 101 Decision in Bascom Global Internet

In Bascom Global Internet v. AT&T Mobility LLC, Bascom Global sued for infringement of US Patent No. 5,987,606, titled “Method And System For Content Filtering Information Retrieved From An Internet Computer Network,” November 16, 1999 (the ’606 patent). The defendant moved to dismiss the complaint under Rule 12(b)(6), and the motion for dismissal was granted … Continue Reading

USPTO Memo re Enfish v. Microsoft

This is an update to my recent article about the Federal Circuit’s decision in Enfish v. Microsoft. In a memo to the Patent Examining Corps dated May 19, 2016, Deputy Commissioner Robert Bahr said that the Enfish decision provides “additional information and clarification on the inquiry for identifying abstract ideas.” The gist of the memo … Continue Reading

Major 101 Decision – Enfish v. Microsoft

Today in Enfish v. Microsoft, the Federal Circuit held software claims patent eligible, reversing the district court’s grant of summary judgment on 101. This is a major decision because it is only the second since Alice where the Federal Circuit has held patent claims eligible (DDR being the first). Further, the case heavily emphasizes that … Continue Reading

USPTO Releases Next Iteration of Examiner Guidance on Patent Subject Matter Eligibility

On May 5, 2016, the USPTO released an update to its examiner guidance on patent subject matter eligibility. The update includes a new set of life science examples, a memorandum to the patent examining corps with instructions on formulating subject matter eligibility rejections and responding to applicants’ replies, an index of eligibility examples, and an … Continue Reading

Patent Drafting Post-Alice: Broadly Define the Problem, and Narrowly Claim the Solutions

The notion of strategic claim drafting, which experienced patent practitioners understand, is all about writing specific, narrowly defined claims to cover the strategically important “choke points” in a value chain.[1] The rationale is that the narrowness of the claim makes it less vulnerable to a validity attack on prior art grounds. In the discussion below, … Continue Reading

In Re Smith: A Raw Deal for Inventors?

The recent decision in In re Smith (Fed. Cir. 2016), in which the Federal Circuit affirmed the rejection of claims 1-18 as being ineligible for patent under 35 USC § 101, represents another example of the shrinking scope of patent-eligibility since the Supreme Court’s Alice decision.[1] As discussed below, this case concerned the patent-eligibility of … Continue Reading

USPTO Updates Guidance on Subject Matter Eligibility

[For background, see our prior posts on July 2, 2014, August 5, 2014, December 18, 2014, and March 23, 2015.] On July 30, 2015, the United States Patent & Trademark Office (USPTO) published an update to its 2014 Interim Guidance on Subject Matter Eligibility (2014 IEG) published on December 16, 2014.[1] Comments to the 2014 … Continue Reading

USPTO Urged to Revise Interim §101 Guidance to Require Examiners to Present a Proper Prima Facie Case Supported by Factual Evidence

As previously reported, on December 15, 2014, the U.S. Patent and Trademark Office (USPTO) published a document titled “2014 Interim Guidance on Patent Subject Matter Eligibility” (Interim Guidance). This Interim Guidance was published as a notice for comments with the possibility of being revised, depending on public feedback. On March 16, 2015, two of the … Continue Reading

USPTO Issues “2014 Interim Guidance on Patent Subject Matter Eligibility”

On December 15, 2014, the USPTO published a document titled “2014 Interim Guidance on Patent Subject Matter Eligibility” (Interim Guidance). The new Interim Guidance follows the previous preliminary examination instructions issued on June 25, 2014, in view of CLS v. Alice (2014), and was published as a notice for comments and may therefore be updated … Continue Reading

Public Comments to USPTO’s Preliminary Examination Instructions in View of Supreme Court Decision in Alice Case

As reported here last month, the USPTO recently issued a memorandum to the Examination Corps, entitled “Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.” The memorandum provides preliminary instructions to the Patent Examining Corps relating to subject matter eligibility of claims involving … Continue Reading

USPTO Issues “Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.”

On June 25, 2014, the USPTO issued a memorandum to the Examination Corps, entitled “Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.” This memorandum provides preliminary instructions, effective June 25, 2014, to the Patent Examining Corps relating to subject matter eligibility of … Continue Reading
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