Three Easy Solutions to the McKesson Problem

24 June 2010 PharmaPatents Blog
Authors: Courtenay C. Brinckerhoff

Federal Circuit decisions such as McKesson Information Solutions, Inc. v. Bridge Medical, Inc., 487 F.3d 897 (Fed. Cir. 2007), indicate that there can be a duty to disclose information from co-pendng U.S. applications, including Office Actions and cited references. However, the USPTO’s current IDS rules do not provide an efficient framework for citing information from a co-pending U.S. application that is undergoing parallel examination. As a result, applicants are forced to submit copies of documents already in the hands of the USPTO and to undertake the costly and time-consuming process of filing Requests for Continued Examination (RCEs) in order to comply with the current IDS rules.

Now that it has been three years since the McKesson decision was issued, the time for the USPTO to relieve the burden of these decisions is long overdue. Here are three simple solutions that the USPTO could adopt:

(1) Extend MPEP 2001.06(b) to Co-Pending U.S. Applications

MPEP 2001.06(b) provides that if an application is filed as a CON, DIV or CIP of an earlier application, the examiner will consider the prior art cited in the earlier application without the applicant having to cite to same art in the later application. The USPTO should extend this provision to co-pending U.S. applications that are identified by the applicant.

Thus, once an applicant identifies a co-pending U.S. application (such as in an initial IDS), the examiner—not the applicant—would be obligated to periodically check the co-pending application file for new information that may be material to patentability. The examiner could do this, for example, prior to issuing each Office Action or a Notice of Allowance. This extra step could actually reduce examiner workload, because examiners could quickly assess whether any new information is relevant to patentability instead of having to review and process an IDS submitted by the applicant.

(2) Extend 37 C.F.R. 1.97 to Co-Pending Applications

The timing requirements of the current IDS rules include several exceptions for information first cited in a counterpart foreign application. The USPTO should extend these provisions to co-pending U.S. patent applications.

Thus, applicants could submit information newly cited in a co-pending U.S. application without having to pay a fee (after a first Office Action) or file an RCE (after a final Office Action). There is no reason the USPTO should make it more difficult for applicants to obtain consideration of information produced in a co-pending U.S. application as compared to a foreign application.

(3) Extend 37 C.F.R. 1.98 to Co-Pending U.S. Applications 

The documentation requirements of the current IDS rules require applicants to submit copies of all references (other than U.S. patent documents) unless the references already were cited in an earlier U.S. parent application. The USPTO should extend this exception to co-pending U.S. applications.

Under current practice, if an Office Action is issued in a co-pending U.S. application that is not a parent application, applicants must file copies of the Office Action and cited references to comply with the IDS rules for the other application. In essence, an applicant must copy and re-file at the USPTO the same documents that the USPTO just copied and mailed to the applicant. This can amount to a tremendous administrative burden (not to mention a colossal waste of paper) as stacks of references may need to copied or scanned. This can be a particular problem in chemical and biotech applications, where the cited references may include long PCT applications or applications with lengthy Sequence Listings.

An examiner can access information of record in the co-pending application electronically, and nearly as easily as information of record in the application at hand. Thus, there is no justification for imposing this burden on applicants. Indeed, this rule stems from the days of paper patent files, and now is obsolete in view of the USPTO’s electronic file system

The USPTO Should Act Now

Any one of these changes would go a long way towards addressing the burdens of the duty to disclose information produced in a co-pending U.S. application. The USPTO should act now to adopt these solutions and realize improved examination efficiency and immediate cost savings for both applicants and the USPTO itself.

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