Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 209

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 209
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 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.

 40 

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 governmental fees on patents and/or patent applications are due to
be paid to the USPTO and foreign patent agencies in several stages over the lifetime of the patent and/or patent application. The USPTO
and various foreign governmental patent agencies also require compliance with a number of procedural, documentary, fee payment, and other
similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late
fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment
or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Non-compliance
events that could result in abandonment or lapse