Company: PFSA
Filing Date: 2025-10-29
Form Type: 424B3
Source: 0001213900-25-103174
Chunk: 89

Company: Profusa, Inc.
Filing Date: 2025-10-29
Form: 424B3
Chunk 89
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 prosecution of the patent
withheld relevant information from the USPTO, or made a misleading statement during prosecution. Third parties may also raise similar
claims before the USPTO even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability
is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art of
which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or
unenforceability, we would lose at least part, and perhaps all, of the challenged patent. Such a loss of patent protection would have
a material adverse impact on our business.

Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products.

The America Invents Act, or
AIA, introduced changes that limit where a patent holder may file a patent infringement suit and providing additional opportunities for
third parties to challenge any issued patent in the USPTO. This applies to all of our owned and in-licensed U.S. patents, even
those issued before March 16, 2013 (the effective date of the AIA). Because of a lower evidentiary standard in USPTO 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. The AIA 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.

Additionally, the U.S. Supreme
Court has ruled on several patent cases in recent years, such as Impression Products, Inc. v. Lexmark International, Inc., Association for Molecular Pathology v. Myriad Genetics, Inc., Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corporation Pty. Ltd. v. CLS Bank International, either narrowing the scope of patent protection available in certain circumstances
or weakening the rights of patent owners in certain situations. In addition to