Top 10 Observations on US Restriction Requirements on Biotech/Pharma Cases

This is written from the perspective of a European Patent Attorney to assist European clients in understanding US restriction requirements that issue on biotech/pharma cases.

1.  US restriction requirements are often compared to lack of unity objections.  They are not, but lack of unity can contribute to the defining of the restriction groups identified by the Examiner.  It is an aspect of the US system that must be accepted, and often there does not seem to be a clear rationale for the groups that are identified.  In theory subject matter in different restriction groups is patentably distinct from each other, but this is not a straightforward concept.

2.  One way of trying to make sense of restriction groups is to see them as dividing the claimed subject matter based on ‘structural’ considerations, so for example proteins and the nucleic acids that encode them may be placed in different restriction groups.  Products and methods of making them can be placed in different restriction groups.

3.  On biotech/pharma cases it is not unusual for around 8 to 10 groups to be identified, and sometimes up to 20. 

4.  The option of arguing against the restriction finding is available.  This can be successful, and so should be considered.  However whether or not to argue is a complex decision because often it requires commenting on patentability before substantive examination has begun.  Clearly in cases where the Examiner has made assumptions which are not correct arguments are more likely to succeed.

5.  Reasons for not arguing against a restriction requirement include the short term given for responding to the restriction requirement, wanting to defer costs and wanting to defer filing complex arguments until substantive examination.

6.  Whether or not arguments will be filed in response to the restriction requirement a group must be elected.  It is important to carefully consider which group to elect.  Normally one chooses a group based on its commercial importance and how likely those claims are to be allowed.  Clearly this is an important decision given the potential loss of claim scope that could occur.

7. Once a group has been elected, one must assume that the claims cannot be amended in a way where they would fall into another identified restriction group.  That can sometimes cause problems in examination where for example conversion of a product claim to a method claim would be desirable to overcome objections, but which is not possible given the way the subject matter was divided into restriction groups.

8. As part of the restriction requirement there may also be a requirement to elect a species.  This is to assist in searching and focussing examination and does not result in loss of claim scope.  However there is a possibility that in examination restricting to the elected species may be suggested by the Examiner, and therefore careful thought should be given to which species are elected.

9.  Bear in mind the possibility of a rejoinder at the end of examination, where the Examiner may join to the allowed claims non-elected claims if they have the features which result in patentability.  Therefore non-elected claims should not be ignored during examination, and consideration should be given to amending them as examination proceeds to increase the possibility of rejoinder being considered.

10.  Divisional applications can be filed to unelected subject matter.  So in theory loss of claim scope can be avoided.  However in practice cost considerations will limit the number of divisional applications that can be filed.

You may also wish to see related articles Top 10 Tips for Inventive Step (Obviousness) Success and Top 10 Tips For Success In EPO Appeals on Biotech Cases