Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 121

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 121
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 secrets, and operate without infringing valid and enforceable intellectual property rights of others.

The patent positions for biotechnology companies like ours are generally uncertain and can involve complex legal, scientific, and factual issues. In addition, the coverage claimed in a patent application can be significantly reduced before a patent is issued, and its scope can be reinterpreted and even challenged after issuance. As a result, we cannot guarantee that any of our product candidates will be protectable or remain protected by enforceable patents. We cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Any patents that we hold may be challenged, circumvented, or invalidated by third parties.

As of December 31, 2024, we and our OncoSelect ®subsidiary have a patent estate that includes 17 issued U.S. and foreign counterpart patents including two U.S. patents and 15 foreign counterpart patents in Australia, Canada, China, France, Germany, Hong Kong, India, Italy, Mexico, Japan, Spain, Sweden, and the United Kingdom. We and OncoSelect ®own all patents and trademarks in our intellectual property portfolio. One U.S. patent and nine counterpart foreign patents directed at diagnostic applications expire in 2030 and one foreign patent directed at a diagnostic application expires in 2039. One U.S. patent and five counterpart foreign patents directed at therapeutic applications expire in 2037.

With regard to our diagnostic patent portfolio, we have one issued U.S. patent and nine foreign counterpart patents in Canada, China, France, Germany, Hong Kong, Italy, Spain, Sweden, and the United Kingdom with another recently awarded diagnostic patent in Japan. Our diagnostic patent applications, fall into one of two families: one directed at diagnosing lung health using flow cytometry and the other directed at proprietary compensation beads used in analysis by flow cytometry. The diagnostic family of pending patent applications is directed at diagnosing lung health and includes three pending non-provisional U.S. patent applications and 18 foreign counterpart patent applications in Australia, Canada, China, European Patent Office, Hong Kong, Japan, Mexico, and Singapore filed in 2019 and 2024, one non-provisional U.S. patent application directed to compensation beads for flow cytometry and one International Patent Application filed in 2023 directed to diagnosing lung health.

With regard to our therapeutic product candidates, we have one issued U.S. patent, five issued foreign