Wave Neuroscience alleged that Brain Frequency infringed four patents in this case. The vast majority of claims asserted in this litigation against Brain Frequency are method claims that relate to the performance of a medical procedure by medical practitioners on patients. Defendants claimed that Brain Frequency is immune because it is a “related health care entity” that merely facilitates the performance of those accused medical activities by medical practitioners.
Section 287(c) of the Patent Act, known as the Physician’s Immunity Statute, mandates an exception to infringement claims asserted under Section 271 (a) and (b) of the Patent Act. In cases where infringement allegations involve medical practitioners or physicians performing medical procedures on patients in violation of an asserted method claim, these parties are immune from all remedies associated with the alleged infringement.
The Plaintiffs contended that Brain Frequency is neither a medical provider nor a facility where medical providers practice medicine.
Wave filed a motion to strike Brain’s expert report of Dr. Jared Dempsey under Federal Rule of Evidence 702. The Court granted Wave’s motion “without prejudice to the extent Brain can cure the deficiencies with Dempsey’s qualifications.” Two weeks later—on October 17, 2024—Brain filed a “Notice of Cure.” This included a revised declaration by Dempsey which, among other things, detailed his involvement in the Study. Brain also filed, under seal, the study itself. Brain contended that this information cured the deficiencies.
Psychology Expert Witness
Jared P. Dempsey, Ph.D. serves as Chief Scientist at Trac9 Informatics. Dempsey is actively involved in neurological and physiological research in addiction.
Recent publications include preliminary evidence for a biological marker of addiction recovery, non-conscious emotional response to drug stimuli, and the influence of social anxiety on addiction treatment.
Dempsey has also served as an expert reviewer for the Journal of Motivation and Emotion, Psychopharmacology, Journal of Psychopathology and Behavioral Assessment, American Journal on Addictions, Addiction, Psychiatry Research, European Psychiatry, Nicotine and Tobacco Research, and the Journal of Studies on Alcohol and Drugs.
Dempsey was also actively involved in the development of a comprehensive symptom tracking and outcome data collection tool for addiction treatment, Trac9.
Discussion by the Court
Initially, the Court held that Dempsey did not have the proper qualifications because there was insufficient evidence to demonstrate he had “advanced training or experience” in Transcranial Magnetic Stimulation (“TMS”). The Court found that the reference to a single research project related to TMS from May 2022–April 2024 (the “Study”) on Dempsey’s curriculum vitae, without further information, did not establish that he had a “hands-on or technology-facing” role.
However, Dempsey attests that he directly participated in the treatment of subjects using TMS and EEG technology, that he outlined the precise treatment protocols used in the study, and that he participated in the actual application of TMS using EEG and certain software to gauge the effects. This appeared to be a “forward-facing role.” Dempsey further states he has worked on the Study since 2022 for over 1,000 hours, along with months of preparatory work.
Wave’s Objections
The Court held that Wave’s two objections are unavailing. First, Wave maintained that Dempsey is not qualified to opine as a person of ordinary skill in the art (“POSITA”). Its primary qualm is that Dempsey does not explain “the nature of actual TMS treatments provided.” But the Study itself explains the nature of the treatments. And the Court does not see how the “nature of the treatments,” or what the TMS treatments were targeted to, would affect whether Dempsey is a POSITA. Wave’s own proposed definition of a POSITA is not cabined to a specific type of TMS treatment.
Second, Wave also claims that it will suffer undue prejudice if Brain is granted relief. The Court does not see how Dempsey’s testimony, if any, would prejudice Wave. Wave has been on notice of Dempsey’s testimony since at least May 2024 when Brain filed its opening claim construction brief. The October 2, 2024 status conference proceeded under the assumption that Dempsey would testify at the Markman hearing. The Court explicitly granted Brain an opportunity to cure the deficiencies in its designation. The Court added that any assumption on Wave’s part that Dempsey’s conclusions or testimony would be permanently excluded was unwarranted.
Because Brain has cured the deficiencies in Dempsey’s designation as a POSITA, the Court vacated the order granting Wave’s motion to strike. Wave may, of course, seek appropriate discovery, including an abbreviated deposition of Dempsey, to inquire into issues that impact the credibility and weight of his testimony (e.g., his background, experience, and any other appropriate matters). Such discovery will be sufficient to cure any “prejudice” that Wave has suffered in the past three weeks.
Held
The Court held that the that the order granting motion to strike Brain Frequency’s expert Jared Dempsey is vacated, and Wave’s motion to strike Dempsey is denied.
Key Takeaway:
Initially, the Court held that Dempsey did not have the proper qualifications because there was insufficient evidence to demonstrate he had “advanced training or experience” in Transcranial Magnetic Stimulation (“TMS”). Two weeks later, Dempsey submitted a revised declaration which, among other things, detailed his involvement in the Study. The Court found that Dempsey directly participated in the treatment of subjects using TMS and EEG technology, that he outlined the precise treatment protocols used in the study, and that he participated in the actual application of TMS using EEG and certain software to gauge the effects.
Case Details:
| Case Caption: | Wave Neuroscience, Inc. V. Brain Frequency Llc Et Al |
| Docket Number: | 5:23cv626 |
| Court: | United States District Court, Texas Western |
| Order Date: | October 22, 2024 |
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