Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 79

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 79
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 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 cognizant going
forward of the time from invention to filing of a patent application, but circumstances could prevent us from promptly filing patent
applications on our inventions. Since patent applications in the U.S. and most other countries are confidential for a period of time
after filing or until issuance, we cannot be certain that we or our licensors were the first to either (1) file any patent application
related to our diagnostic tests and therapeutic product candidates and other proprietary technologies we may develop or (2) invent any
of the inventions claimed in our or our licensor’s patents or patent applications. Even where we have a valid and enforceable patent,
we may not be able to exclude others from practicing the claimed invention where the other party can show that they used the invention
in commerce before our filing date. 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.

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