The Petitioner proposes to establish a U.S. business developing an AI-driven digital platform to recruit underrepresented ethnic minorities into clinical drug trials, working with contract research organizations, biopharmaceutical companies, and academic health systems to improve diversity and equity in the U.S. drug development process.

Prong 1 — national importancenot established · dispositive

“The Petitioner has not sufficiently explained his particular endeavor's impact beyond his business, its employees, and its customers.”

“The record does not establish that his proposed seven-person business could recruit enough minorities into the U.S. drug development process to have national health or economic implications.”

“he has not established that his proposed clinical research platform represents an advancement over current clinical trial recruitment tools in the field.”

“recruiting minorities to participate in clinical drug trials would further a national goal of eliminating healthcare disparities. But - unless the recruitment tool itself represents an advancement in the field - such recruitment for a limited number of clinical trials would not likely have national implications.”

“The record lacks independent documentary evidence substantiating counsel's assertions that the Petitioner's proposed clinical trial recruitment tool would advance his field.”

AAO decision text

How the evidence was treated

• other · discounted

  “reliance on background information and statistics concerning various topics is generally not probative”

  AAO decision text
• recommendation letter · discounted

  “do not discuss his proposed platform or its claimed significance in detail. The letters do not explain how his proposed system would represent an advancement over existing clinical trial recruitment tools.”

  AAO decision text
• business plan · discounted

  “counsel made these statements, and thus they are not evidence”

  AAO decision text
• other · credited

Where this case turned

• Business plan speculative · p1 — projections without a documented basis or steps
• Employer-specific benefit · p1 — "work furthers my company's product" — value accrues to one firm
• Field importance conflated with endeavor · p1 — argues the field matters, not the specific endeavor
• Local, not national scope · p1 — impact confined to clients / a region

Notable

The AAO explicitly distinguished this case from Dhanasar itself, noting that Dhanasar's endeavor involved publishing research broadly available to the field, whereas this petitioner's platform would be shared only with co-workers and paying customers. The AAO also cited a footnote referencing a third-party list of at least 75 competing clinical trial recruitment technology companies to undercut the novelty argument. The AAO agreed with the petitioner's legal argument that supporting evidence need not explicitly reference the specific endeavor, but still found the evidence insufficient to show the specific endeavor's broad implications.

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