USPTO Offers Guidance on Supplemental Examination

31 December 2012 PharmaPatents Blog

The USPTO has published “Tips for Filing a Compliant Supplemental Examination Request” on its AIA Implementation Web page. According to the notice, the USPTO has received six requests for Supplemental Examination, but apparently not all of them complied with the USPTO’s rules. Luckily for patent owners, Wequests for Supplemental Examination are not made public unless and until they have been found to satisfy the filing date requirements. Thus, patent owners who file non-compliant requests have an opportunity to cure them before they are made public. The “tips” in the notice underscore the importance of following the rules to a “T,” and making it easy for the USPTO to determine why the “information” is being submitted and whether it is “relevant to the patent.”

The Statutory Requirements

The statute (35 USC § 257) provides that the USPTO can set the requirements for a request for Supplemental Examination:

(a) REQUEST FOR SUPPLEMENTAL EXAMINATION.—A patent owner may request supplemental examination of a patent in the Office to consider, reconsider, or correct information believed to be relevant to the patent, in accordance with such requirements as the Director may establish. Within 3 months after the date a request for supplemental examination meeting the requirements of this section is received, the Director shall conduct the supplemental examination and shall conclude such examination by issuing a certificate indicating whether the information presented in the request raises a substantial new question of patentability.

The Supplemental Examination Rules

The Supplemental Examination rules are set forth in 37 CFR § 1.601 - 1.625. The “tips” focus on 37 CFR § 1.610(b)(5), which requires a request for Supplemental Examination to include:

A separate, detailed explanation of the relevance and manner of applying each item of information to each claim of the patent for which supplemental examination is requested.

The “tips” also touch on 37 CFR § 1.610(c), which permits a request to also include:

(3) An explanation of how the claims patentably distinguish over the items of information; and

(4) An explanation of why each item of information submitted with the request does or does not raise a substantial new question of patentability.

USPTO Tips for the Detailed Explanation of Relevance 

According to the notice, “[t]he most common reason for non-compliance was the failure to provide a separate, detailed explanation of the relevance and manner of applying each item of information to each claim identified in the request,” as required by 37 CFR §1.610(b)(5). Thus, the USPTO offers “additional guidance” on this requirement:

A separate, detailed explanation required by 37 CFR 1.610(b)(5) must state how each item of information is applicable to each claim limitation. A general statement of relevance that is not tied to any particular claim limitation is not sufficient to meet the requirement. The explanation, however, does not need to positively state that an item of information “teaches” a limitation, but instead that it has teachings that a reasonable examiner might view as important to that limitation. The explanation should include citations to particular portions or figures in the item of information in which the relevant teachings are located. Patent owners are encouraged to be as comprehensive as possible in the explanation. This allows for the patent owner to frame the issues and assists the examiner in focusing on the pertinent issues to better determine whether a substantial new question of patentability (SNQ) is raised. Generally, the guidance provided in MPEP 2214 for the content of a request for ex parte reexamination is a good resource.

When multiple “items of information” are submitted and multiple claims are at issue, the request must provide detailed explanations for each reference and each claim:

  • The request must include ”separate, detailed explanations of how each [item] of information applies to [each claim].”
  • The request must include “a separate, detailed explanation … for each dependent claim,” unless the request explicitly states that the application of the item of information to the independent claim is being relied upon as the explanation for the dependent claim(s).

Requests that fail to provide detailed explanations for each reference and each claim will be deemed non-compliant, and will not receive a filing date.

The USPTO also emphasizes that “the explanation requirement is NOT met by incorporating by reference a paper in another proceeding or relying on a third party’s paper submitted with the request.” Rather, “[t]he explanation must be presented as the patent owner’s position.”

The detailed explanation in the request must stand on its own, and must reflect the opinion of the patent owner, and not that of a third party.

USPTO Tips for Any Discussion of Patentability 

As noted above, 37 CFR § 1.610 provides that a request may include a discussion of why the claims are patentable over the item(s) of information. However, the USPTO wants this “optional discussion” to be made “under a separate subheading” from the “detailed explanation,” such as under the subheading “Explanation under 37 CFR 1.610(c)(3).” Apparently, requests that combine the “detailed explanation” with the “optional discussion” focus too much “on why the claims are patentable” and provide “little to no explanation as to how the item of information is applicable to the claim limitations as required by 37 CFR 1.610(b)(5).” As noted above, if the request doesn’t make it easy for the USPTO to determine that the required detailed explanation has been provided, it is likely to be deemed non-compliant, and not be granted a filing date.

Further USPTO Guidance

The USPTO also has made a “Supplemental Examination best practices guide” available and has a Supplemental Examination Frequently Asked Questions page that is updated from time to time.

 Imposing More Requirements?

Comparing the Supplemental Examination rules to these tips and guidance documents, it is not surprising that some of the first requests were deemed to be non-compliant. For example, the final rules require a detailed explanation for each claim for which supplemental examination is sought, while the new guidance emphasizes the need for a detailed explanation for each claim limitation. This is particularly striking given that the only time that claim limitations are mentioned in the Federal Register Notice setting forth the final rules is where the commentary notes certain proposed requirements that were not adopted, including the proposed requirement to provide “an explanation of how each limitation of each claim … is met, or is not met, by each item of information.”

The requirement to provide a detailed explanation on a claim limitation-by-claim limitation basis may not be objectively unreasonable, but the scolding that “[a] general statement of relevance that is not tied to any particular claim limitation is not sufficient to meet the requirement,” seems inconsistent with the plain language of the final rules. Now that patent owners have been warned about this additional requirement, perhaps more requests will be deemed “complaint” as originally filed.

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