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Ex Parte Reexamination Best Practices
by Peter Bernstein

In an Ex parte reexamination, either a challenger or patent holder may seek reexamination of a patent based on patents or printed publications. The asserted prior art must qualify as prior art under 35 USC 102 (anticipatory) or 103 (obvious) only-i.e. an ex parte reexamination cannot be founded on lack of written description, lack of enablement or lack of antecedent basis-so-called "112 grounds." The requester files the request for reexamination and within three months, the PTO determines whether a substantial new question ("SNQ") of patentability exists. If so, the PTO orders reexamination of the patent.

The process as outlined above is seemingly quite simple. Gather some formidable prior art (preferably prior art that was not previously considered), tell the PTO how it pertains to the claims you want to have reexamined and the PTO makes its "SNQ" determination within 3 months. Nowadays, however, the PTO is quite stringent in its requirements for establishing a SNQ requiring Requesters to shoulder a heavy burden before their request is granted. While not explicitly stated in the MPEP, requesters are advised to make their request as Examiner-friendly as possible by thoroughly and carefully applying the prior art to each claim using a claim chart. Each claim term must be shown to have been disclosed or at least suggested by one or more pieces of prior art. This showing should be represented on a line by line comparative basis as illustrated below.

U.S. Patent No. 1,234,567-Claim 1
1. A composition comprising x, y and z and a pharmaceutically acceptable salt thereof.

Prior Art-Smith et al.
Smith et al. at page 45, col 2, paragraph 4 describes a composition comprising x, y and z and pharmaceutically acceptable salts thereof.

Then the table should be separately explained in detail to establish that a SNQ is present for Claim 1. The actual content requirements for an ex parte reexamination request are found in 37 CFR 1.510. 35 USC 301 requires that the requester explain "the pertinency and manner of applying such prior art to at least one claim of the patent[.]" . This requirement should be carefully adhered to by providing the detailed claim charts as illustrated above. The requester should also copy and annotate figures from the prior art publication into the request. Reliance on quotations and figures from the prior art should be literal to avoid any potential misinterpretation or mischaracterization. In addition, the requester should provide alternative arguments of invalidity. For example, a requester can assert that each claim limitation is met under 35 USC 102 by reference A, and in the alternative , each claim limitation is met under 35 USC 103 by reference A in combination with reference B. The requester should consider including expert declarations to support issues such as explaining the contents of the prior art; supporting a publication date of a reference; addressing motivation(s) to combine references; and rebutting any potential assertions of secondary considerations such as commercial success. Finally, requesters are advised to limit the number of prior art references as much as possible. This strategy will necessarily make the Examiner's job simpler and should serve as an advantage in an environment increasingly focused on making the Examiner's task easier. In addition, the requester must make a statement pointing out the SNQ for each claim sought for reexamination. In current practice, that statement should be quite detailed.

If the PTO orders reexamination, the patent holder is given the opportunity to file a statement concerning the new question of patentability, including amendments or new claims they want to propose (provided, however, that the claims may not be broadened). If the patent holder files such a statement, the statement must be served on the person requesting reexamination, and the requester is given two months to file a reply to the patent owner's statement. From that point on, the claims are examined without participation by the non-patentee requester. Following the Ex parte reexamination, the PTO issues a certificate canceling any claim determined to be unpatentable, confirming any claim determined to be patentable and incorporating in the patent any new claim or amended claim determined to be patentable.







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