Overcoming Restrictions of Method of Treatment Claims

Inventions covering method of treatments, such as treating cancer with a particular antibody, have had a rough go of late. They are under attack by the PTAB under section 101 as discussed in one of the pharma blogs (PTAB Puts Method Of Treatment Patents Under The 101 Knife), but seem to have received a lifeline from the Federal Circuit in Vanda.

Another way in which the USPTO curtails method of treatment inventions is to issue complex restrictions meant to give the applicant a form of death by a thousand cuts. However, there are ways to push back against such restrictions and application S/N 13/282,065 illustrates some of the tools available.

The case relates to a method of treating cancer in a human by administering an anti-activin receptor-like kinase-1 (ALK-1) antibody or antigen-binding portion thereof, where the antibody comprises the heavy chain CDR1-3 and the light chain CDR1-3 found in certain amino acid sequences. The pending claims included not only method of treatment claims, but also methods for inhibiting angiogenesis, including methods specifying that the antibody comprises certain sequences encoded by the nucleotide sequence of the plasmid insert found in a certain E.Coli clone and methods for treating hepatobiliary cancer.

The Examiner required a restriction among three groups, as well as an election of various species. The Applicant here rightly traversed by pointing out that all three groups were categorized in the same field of search (i.e., the same class and subclass), and that therefore there could be no serious search burden. While one would think that this simple point would be sufficient for the Examiner to simply withdraw the restriction, the Examiner nonetheless maintained their position forcing the application to go through the expense and delay of a petition.

Further, the Examiner attempted to stick the applicant with some admissions (which would have been very damaging in the prosecution history) that the claims were admitted to be "co-extensive." Of course the applicant did not makes such statements, and rightly pointed this out in the petition. While not the focus of this post, it should be appreciated that one must be vigilant and acutely on-guard to ensure the Examiner does not improperly stick the applicant with what could be a devastating admission. 

Turning back to the Petition, the applicant pointed out the lack of search burden and the Office of Petitions agreed.


So, if you are prosecuting treatment methods and encounter restriction roadblocks, consider whether the Office has properly established all of the requirements for restriction, including that there would be a serious search burden in examining all of the claims together, especially if they are all in the same class and subclass.