By Dennis Crouch

Over the past year I’ve been investigating various generative Artificial Intelligence (GenAI) tools for assisting patent attorneys in their practice.  I have a strong belief that these tools and their progeny are now fixtures in our legal environment and are being used to both improve efficient delivery of legal services and to also improve the quality of those services.  Of course the generative creativity of our LLMs go hand in hand with hidden false narratives or hallucinations. Vendors are stepping up to thread the needle here: providing valuable GenAI tools while limiting false story telling.  As we move forward some of the struggle will be a focus on how much the attorney needs to know about how the GenAI works in order to use it responsibly.

Enter the USPTO and its Wet Blanket: The USPTO has released new guidance on the use of AI tools in practice before the USPTO. (more…)

By Dennis Crouch

In a recent unpublished decision, the Georgia Court of Appeals affirmed summary judgment in favor of CPA Global Support Services, LLC (“CPA”) (now part of Clarivate) against a claim of negligent misrepresentation brought by inventor James C. Robinson, M.D. and his patent holding company (Spectrum Spine).  Robinson’s firm FisherBroyles had relied upon the dates erroneously entered by CPA and missed the national stage filing deadlines.  The parallel case against FisherBroyles is still pending in Georgia state court. Robinson v. CPA Global Support Services, LLC, No. A24A0405 (Ga. Ct. App. Apr. 8, 2024). CPA vs Robinson.

The case serves as an important reminder about the limitations on vendor liability for negligent misrepresentation claims in the absence of contractual privity — and how attorneys are often stuck in the middle.

What are your thoughts on how to avoid this situation? (more…)

by Dennis Crouch

In a non-precedential opinion, the Federal Circuit has affirmed the US International Trade Commission’s (ITC) final determination in the patent infringement dispute between Sonos and Google involving smart speaker technology. Sonos, Inc. v. Int’l Trade Comm’n, Nos. 2022-1421, 2022-1573 (Fed. Cir. Apr. 8, 2024).  The ITC had issued a split opinion – finding that Google infringed a number of Sonos speaker patents, but concluded that Google’s proposed work-around was non-infringing.  Both sides appealed and the Federal Circuit’s deferential standard of review resulted in a full affirmance. The outcome then (more…)

by Dennis Crouch

Although non-precedential, the Federal Circuit’s new decision in Sumitomo Pharma v. Vidal offers the important conclusion that a patentee has no standing to appeal an invalidity holding once the patent expires, absent some showing of likely infringement during the prior six years.  Sumitomo Pharma Co. v. Vidal, No. 22-2276 (Fed. Cir. April 5, 2024).  The case is not so bad for the patentee because (more…)

by Dennis Crouch

The United States Patent and Trademark Office (USPTO) recently proposed a new fee structure for fiscal year 2025, which includes significant increases in various patent fees. [Read the Notice of Proposed Rulemaking] While incremental fee adjustments are common, the proposed changes for FY2025 are particularly noteworthy due to their magnitude in certain targeted areas and potential impact on applicant behavior. Many filers will likely change their practices based on the new higher fees. The USPTO appears to be using these fee adjustments as a tool to shape patent prosecution strategies, encouraging more compact patent applications and smaller patent families.  However, the USPTO is also seeking ways to ensure that the agency remains financially solvent and able to perform its statutory duties in the face of inflation and the Unleashing American Innovators Act of 2022 which reduced patent fees for small and micro entity applicants. The USPTO’s proposed fee increases are largely unchanged from the plan announced last year.

One of the most striking changes in the proposed fee structure . . . (more…)

by Dennis Crouch

On January 23, 2024, the Federal Circuit granted the USPTO’s request for a remand in the case of In re Xencor, Inc. The appeal focused on two important issues concerning written description requirements for means-plus-function (MPF) and Jepson claims in the context of antibody patents. The USPTO had indicated that it wanted to reconsider its approach to these issues and convene its newly established Appeals Review Panel (ARP) to clarify its position. (ARP is the new POP). As part of its justification for remand, the Federal Circuit noted its expectation “that proceedings will be conducted expeditiously.”

However, more than two months after the remand order, there has been no visible progress in the case. The USPTO has not docketed the case with the ARP, and no public announcement has been made regarding the composition of the panel that will review the case. Furthermore, the prosecution history of the application in question (USPTO Application Number 16/803,690) does not reflect any updates or changes since the remand.

This lack of action is particularly concerning given the significance of the issues at stake. The PTAB previously made two controversial rulings that were on appeal: (1) that under 35 U.S.C. 112(f) equivalents require explicit written description support and (2) that non-limiting Jepson claim preambles also require such support, even if they do not limit claim scope.

Meanwhile, the USPTO did recently issue examination guidance on examining means-plus-function claim limitations under 112(f).  The troubling aspect of the memo, however, is that it does not provide any guidance on the Xencor enablement issue.

Citations:
[1] https://patentlyo.com/patent/2023/12/motion-remand-xencor.html
[2] https://patentlyo.com/patent/2024/01/important-antibody-description.html
[3] https://cafc.uscourts.gov/01-23-2024-23-2048-in-re-xencor-inc-order-23-2048-order-1-23-2024_2257719/

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by Dennis Crouch

In Rady v. The Boston Consulting Group, Inc., No. 2022-2218 (Fed. Cir. Mar. 27, 2024), the Federal Circuit affirmed the dismissal of a patent infringement lawsuit, holding that the asserted claims of Rady’s US10469250 were ineligible under 35 U.S.C. § 101.  The patent, owned by Max Rady, patent describes scanning a physical item, determining its unique pattern of imperfections (i.e., “signature”), and recording that signature to a blockchain if not previously registered.

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by Dennis Crouch

In April 2024, the Federal Circuit issued a significant decision vacating a district court’s judgment that Janssen Pharmaceuticals’ dosing regimen patent claims were nonobvious. Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258 (Fed. Cir. Apr. 1, 2024). The case involved Janson’s U.S. Patent No. 9,439,906, which claims methods of treating schizophrenia by administering specific doses of the long-acting injectable antipsychotic paliperidone palmitate.

Teva filed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Janssen’s Invega Sustenna product, which embodies the claimed methods. In the ensuing Hatch-Waxman litigation, Teva stipulated to infringement but challenged the patent on obviousness and indefiniteness grounds. Following a bench trial Judge Cecchi (D.N.J.) rejected Teva’s invalidity defenses, and Teva appealed.

On appeal, Judge Prost authored a unanimous opinion affirming the district court’s indefiniteness determination but vacating and remanding on obviousness.  Overall, this is a bad case for pharmaceutical formulary patents.

This post focuses on the court’s obviousness holding and its potential implications for pharmaceutical method of treatment claims more broadly. I make three key claims. . .

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by Dennis Crouch

The Federal Circuit’s recent 2-1 decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. highlights tensions in the court’s interpretation of the patent infringement safe harbor under 35 U.S.C. § 271(e)(1). A forceful dissent by Judge Lourie argues that the majority’s approach, while following precedent, improperly reads the word “solely” out of the statute and unduly expands the safe harbor exemption.  Lourie ends his opinion with a call for en banc rehearing.

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by Dennis Crouch

The U.S. Supreme Court is weighing whether to grant certiorari in Vanda Pharmaceuticals v. Teva Pharmaceuticals. I have been closely watching this obviousness case that could have significant implications beyond the pharmaceutical industry.  The following essay provides an overview of the key legal issues at stake and introduces Teva’s recent briefing.

The case centers on the proper legal standard for determining when an invention is “obvious” and therefore unpatentable under 35 U.S.C. § 103.  In particular, Vanda argues that the Federal Circuit has unduly raised the non-obviousness hurdle — barring patents based upon a “mere reasonable expectation of success” or that certain experiments would have been obvious to try, even though the result was not known.

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This week USPTO Commissioner for Patents Vaishali Udupa issued a memorandum to all patent examiners entitled “Resources for Examining Means-Plus-Function and Step-Plus-Function Claim Limitations (35 U.S.C. 112(f)).” The purpose of the memo is to remind examiners of the resources and guidance available when examining claims under 35 U.S.C. 112(f), commonly referred to as “means-plus-function” or “step-plus-function” claims. The memo summarizes key points regarding:

1. Determining whether a claim limitation invokes 112(f)
2. Clearly communicating on the record when 112(f) has been invoked
3. Evaluating the adequacy of the supporting disclosure

The USPTO has also requested public feedback on the guidance (6/18/24 deadline).  Examiners will apparently undergo some training. Although not clear if this will be enforced, it may become more of a requirement for examiners to provide a claim construction section in their office action rejections.

Although the memo is generally helpful, there are two points of guidance that are lacking, and that I discuss below:

1. How is BRI applied at the initial stage of determining whether a claim is written in means-plus-function form?
2. How are means-plus-function limitations evaluated under the 112(a) written description and enablement requirements. Particular, must the “equivalents” covered by the claim be adequately supported by the specification?

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