Mueting Raasch Group wishes you a Happy New Year!
To assist you in kicking off a productive 2024, we have identified some recent court decisions affecting U.S. patent law, along with takeaways regarding how these decisions might affect U.S. practice.
Problem-solution and non-analogous art:
Takeaway: consider including problem-solution statements in U.S. applications or retaining problem-solution statements when editing an existing application (e.g., an EP application) for filing in the U.S. Instruct your U.S. associates to always consider non-analogous art arguments when applicable, as such arguments have been strengthened with the below court decision.
Summary of Decision: a problem-solution statement in an application can potentially limit whether a prior art reference is reasonably pertinent to the particular problem at issue in the application. Thus, in the U.S., if a reference is cited against your application but (1) it is not in the same field of endeavor and (2) it is not reasonably pertinent to the particular problem at issue, it can be argued to be non-analogous art and unusable in a rejection. See Netflix, Inc. v. DivX, LLC, 2022-1138 (Fed. Cir. Sept. 11, 2023).
Prosecution history and motivation to combine:
Takeaway: don’t leave arguments on the table – consider including arguments that cited references would not be combined because they are not relevant to one another and to the claimed invention. Consider briefly reviewing art cited by the USPTO that is not substantively argued, and distinguishing any art that you think is not relevant to the claimed invention.
Summary of Decision: if multiple references directed to non-analogous or irrelevant art are cited by the USPTO as being obvious to combine and the applicant fails to argue that one of ordinary skill would not be motivated to combine the cited references, the USPTO may conclude that the references are, in fact, relevant to one another and may thus be combined to obviate the claims (even when those references appear to be very different and no motivation to combine them has been asserted by the PTO). See Elekta Limited v. Zap Surgical Systems, Inc., No. 21-1985 (Fed. Cir. Sept. 21, 2023).
Enablement:
Takeaway: consider disclosure and claiming strategies early during development. Identify a common characteristic of the claimed genus that is helpful to identifying working species. Additionally, consider including narrower species claims as backup to broader genus claims. This applies to all technical arts, not just biotech.
Summary of Decision: the U.S. Supreme Court recently held that the number of species claimed needs to correlate to the number of enabled species. In other words, the more you claim the more you must enable. In this case, two patent applications purporting to cover all antibodies that bind and block the PCSK9 receptor involved in LDL cholesterol metabolism failed to satisfy the Patent Act’s enablement clause under 35 U.S.C. § 112(a). The applications included 26 exemplary antibodies, and various methods (e.g., a roadmap) to test other antibodies. However, the court cited that there may be millions of antibodies. Further in this instance, the methods to test other antibodies were not sufficiently detailed and did not identify a common thread between all possible antibodies, and thus the court held the methods were akin to a “hunting license” which would require “painstaking experimentation.” See Amgen, Inc. v. Sanofi, 598 U.S. 594 (2023).
Obviousness-type double patenting and terminal disclaimers:
Takeaway: carefully review all claims in a patent family and analyze possible obviousness-type double patenting (ODP) risks before filing a new application. If you think the risk warrants a terminal disclaimer filed before an ODP rejection is made, make sure to file the terminal disclaimer before the parent application expires. If you think the risk does not warrant a terminal disclaimer filed before an ODP rejection is made, make sure to continue to analyze possible ODP risks over time and return to this analysis before the parent application expires.
Summary of Decision: in the U.S., if a claim of one application (or the resulting patent) is not patentably distinct from a claim of another patent in the same “family tree,” the claim may be invalid under obviousness-type double patenting (ODP). A terminal disclaimer may be filed to overcome an ODP rejection, but only if the earlier-expiring patent referenced in the rejection is still in force (i.e., the earlier-expiring patent has not yet expired). Be aware: if an ODP rejection is never made during prosecution of a “child” application and thus no terminal disclaimer is filed, the “child” patent is granted, and then the “parent” patent eventually expires, patent owners are not yet fully protected. For example, if a reexamination proceeding is opened under the assertion that the “child” patent was actually unpatentable based on ODP, even though no ODP rejection was made during prosecution, the “child” patent may still be rejected, and it will be too late to file a terminal disclaimer to the expired “parent” patent. See In re Cellect, LLC, 81 F.4th 1216 (Fed. Cir. 2023).
We hope the above information will provide you with additional tools as you continue your practice. If you have any follow-up questions, please feel free to contact us.
Have a wonderful 2024!