Free Sample Chapter: Introductory Guide to Intellectual Property for Medical Devices
BY EDITOR, FEBRUARY 24, 2006
February 2010 update: This report is no longer available for purchase. Learn more here.
The U.S. Patent Office Examination Process for Medical Devices
This is a sample chapter from our "Introductory Guide to Intellectual Property for Medical Devices" report, available via immediate download here for $295. (The full table of contents is also available at this page.
The Examination Process
When an applicant files a patent application with the United Stated Patent and Trademark Office ("USPTO"), the Examiner assigned to the case reviews the application to determine whether the claimed invention is patentable. This includes an assessment of whether the claimed invention meets the novelty and non-obviousness requirements. The analysis is performed on a claim by claim basis. The Examiner first performs a search to identify prior art in the relevant field, and then makes a determination as to whether any of the relevant prior art discloses each and every element of the claim. If a single prior art reference discloses each and every element of a claim, that claim is not novel and the claim is said to be "anticipated" by the prior art.
However, even if no single piece of prior art discloses each and every element of the claim, the claim can still be rejected as being obvious if two or more prior art references, taken together, disclose each and every element of the claim (provided the prior art references are from the same or related fields and one of ordinary skill in the art would have been motivated to combine the references). Thus, while the Examiner must identify a single prior art reference that discloses all of the elements of a claim in order to reject the claim for lack of novelty, the Examiner can combine multiple prior art references to reject a claim as being obvious. In making an obviousness rejection, the Examiner considers the level of skill in the art, any secondary considerations, and the other criteria discussed above.
If the Examiner rejects any of the patent claims, whether for failure to meet the novelty, non-obviousness, or any other requirement to patentability, the applicant has two choices of how to proceed. First, the applicant can file a response containing legal arguments as to why the rejection was improper. Alternatively, the applicant can elect to amend (usually narrow) the claim to overcome the Examiner's reasons for rejection. If the Examiner agrees with the applicant, the Examiner may allow one or more of the claims to issue; if not, the Examiner can maintain the rejection or raise other grounds of rejection. This back-and-forth between the applicant and the Examiner can continue until the claims are in condition for allowance or the application is abandoned. Assuming the device meets all of the requirements for patentability, it typically takes between 24-40 months from filing for a patent to issue.
Once the application is on file, the invention, if it is being marketed by the applicant, may be marketed with the notice "patent pending." Such marking serves to put potential infringers on notice of the applicants' potential rights, which notice can be important in determining the damages period if the patent ultimately issues. However, the right to prohibit use of the invention by others does not mature unless and until the patent is ultimately granted. It is only upon grant of the patent that the applicant has any enforceable rights.
After a patent issues, it is presumed valid under the patent statute. However, a party charged with infringement may contest the validity of any claim by showing noncompliance with the conditions of patentability. A party challenging the validity of an issued patent must prove invalidity by clear and convincing evidence.
