Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 56

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 56
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izant 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.

In addition, the patent positions of companies in
the development and commercialization of biologics and pharmaceuticals are particularly uncertain. The U.S. Supreme Court has ruled on
several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening
the rights of patent owners in certain situations. Depending on future actions by the U.S. Congress, the U.S. courts, the USPTO and the
relevant law-making bodies in other countries, the laws and regulations governing patents could change in unpredictable ways that would
weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. For example,
in the 2013 case Assoc. for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held that certain claims to DNA
molecules are not patentable. While we do not believe that any of the patents owned or licensed by us will be found invalid based on this
decision, we cannot predict how future decisions by the courts, Congress or the USPTO may impact the value of our patents.

Obtaining and maintaining patent protection depends on compliance with various procedural, document submissions, fee payment, and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

Periodic maintenance fees, renewal fees, annuities
fees, and various other