Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 55

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 55
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 and licensed patents. Patent reform legislation in the U.S. and other
countries, including the Leahy-Smith America Invents Act (the “Leahy-Smith Act”), signed into law on September 16, 2011, could
increase those uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued
patents. The Leahy-Smith Act included a number of significant changes to U.S. patent law. These include provisions that affect the way
patent applications are prosecuted, redefine prior art, and provide more efficient and cost-effective avenues for competitors to challenge
the validity of patents. These include allowing third-party submission of prior art to the USPTO during patent prosecution and additional
procedures to attack the validity of a patent by USPTO-administered post-grant proceedings, including post-grant review, inter partes
review, and derivation proceedings. Further, because of a lower evidentiary standard in these USPTO post-grant proceedings compared to
the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence
in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate
the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate
our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action.
Thus, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent
applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business,
financial condition, results of operations, and prospects.

After March 2013, under the Leahy-Smith Act, the U.S.
transitioned to a “first inventor to file” system in which, assuming that the other statutory requirements are met, the first
inventor to file a patent application will be titled to the patent on an invention regardless of whether a third party was the first to
invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before we file an application
covering the same invention, could therefore be awarded a patent covering an invention of ours even if we had made the invention before
it was made by such third party. This will require us to be cogn