PTAB Provides Guidance on Rule 132 Declaration Sufficiency
The United States Patent and Trademark Office (USPTO) has recently provided additional guidance to Examiners on the consideration of factual evidence provided in the form of a Declaration under 37 C.F.R. § 1.132 (“Rule 132 declaration”). Understanding these guidelines and the overall utility of Rule 132 declarations is an important tool for practitioners to rebut a prima facie case of obviousness. A Rule 132 declaration is recommended for the introduction of evidence to the record when the evidence to be provided is “on a basis not otherwise provided for” in the application.[1] In these practitioners’ views, Rule 132 declarations should be considered in many, if not a majority, of chemical-related cases. Historically, many practitioners have argued against the use of Rule 132 declarations because of litigation worries (such as inequitable conduct findings for inaccurate / misleading declarations). However, so long as reasonable due diligence is done when obtaining the Rule 132 declaration, in our view the benefits, as discussed below, far outweigh the risks.
A recent Patent Trial and Appeal Board (PTAB) decision in Ex parte Eidschun[2] highlights important considerations for practitioners in avoiding declaration missteps that may lead to unnecessary further Office Actions. In Eidschun, the PTAB considered an appeal of the rejection for obviousness of a claimed anodizing process exemplified by claim 1 of U.S. Appln. No. 17/161,133.
The process required an anodizing solution comprising about 10% w/v to about 20% w/v of at least one acid selected from a group of eight acids, and about 0.01% w/v to about 0.05% w/v of at least one oxidizing agent selected from a group of five oxidizing agents. The claim was rejected by the Examiner as being obvious over Windsor-Bowen, which disclosed an anodizing process using an anodizing solution containing sulfuric acid and crystallized sodium sulfate in addition to optionally containing less than 1% of an oxidizing agent that can be sodium nitrate or potassium nitrate, in view of Haga, which disclosed an anodizing process using an anodizing solution comprising about 5–35 wt% sulfuric acid and an oxidizing agent.
In upholding the rejection, the PTAB provided commentary on the sufficiency of a Rule 132 Declaration that was submitted in rebuttal of the prima facie case of obviousness to provide evidence of unexpectedly superior results. While not a comprehensive discussion of all practical tips surrounding Rule 132 declarations, the decision in Eidschun provides some important advice for practitioners to follow, in hopes of increasing the likelihood of success, when using Rule 132 declarations to overcome an Examiner’s finding of obviousness.
The PTAB raised several issues with the Rule 132 declaration submitted in Eidschun. The first issue relates to the declaration’s failure to compare results to the closest prior art, which is a primary requirement for a demonstration of the presence of unexpected results as evidence of non-obviousness. The Rule 132 declaration in Eidschun focused only on a comparison with the Examiner’s primary reference for the rejection, Windsor-Bowen; however, the PTAB found that the Examiner’s secondary reference, Haga, was actually the closest prior art and set forth a new ground for rejection over Haga in view of Windsor-Bowen. Because the PTAB changed the rejection to be based upon a secondary reference from the record, the declaration focusing on the Windsor-Bowen reference was no longer a comparison to the closest prior art. As such, statements comparing the provided data with each of Windsor-Bowen, Haga, and the combination of references may have provided the PTAB a basis for finding the results were compared to the closest prior art, even when such new grounds of rejection were issued.
The second issue was the failure of the Rule 132 declaration to establish that a person having ordinary skill in the art (PHOSITA) would have recognized the results as unexpected, and not merely different. The Rule 132 declaration provided no support or reasoning for why the demonstrated result would not have been expected in view of the cited art. To persuade an Examiner that the provided results are truly unexpected, and not merely different, practitioners should use a Rule 132 declaration to support statements that explicitly and unambiguously describe the reason(s) that the results would have been unexpected to a PHOSITA. If possible, such statements should also address what the expected results should have been in view of the cited art raised by the Examiner and in view of common knowledge in the art. It is not sufficient to simply state that any obtained results which are different from the cited art are unexpected.
The third issue with the Rule 132 declaration was the failure of the results to cover a scope commensurate with the claims. The results presented in the Rule 132 declaration included an example of only one acid and one oxidizing agent, while the claims encompassed eight possible acids and five oxidizing agents. Table 3, provided in the Rule 132 declaration, included only the concentration ranges of the single acid and single oxidizing agent from the claims and no specific examples with concentrations comprised within the claimed ranges, i.e. the example did not provide the specific concentration used for either of the compounds. Therefore, the declaration did not actually include specific data points indicating any particular trend or given result; it recited ranges from the claims leaving a fact finder without the necessary information to judge whether a stated result occurs at any particular point within, much less over the entirety of, the claimed range. When demonstrating the criticality of a range, it is particularly important to provide, at a minimum, experimental data for examples according to the invention that are near the endpoints of the claimed range, thus supporting each extreme of the range, in addition to data points outside of the claimed range, which demonstrate the unexpected result is not achieved outside of the claimed range. For broader ranges it will be particularly helpful to provide at least a further example near the middle of the claimed range. For claim elements limited by Markush groups, i.e. ranges or groups of items or compounds, it is important to provide examples using as many of the individual options from the grouping as possible. If it is not possible to provide exemplary data for each of the components represented in the claims, an explanation of why the results would be expected for all the claimed components should be provided. However, such an explanation should be accompanied by a robust technical discussion, and preferably evidence to convince an Examiner that the results would be expected for the entire scope of the claims.
Eidschun highlights the importance of appropriate use of a Rule 132 declaration to provide factual evidence and a basis for supporting such arguments to establish non-obviousness. Providing a complete set of data to support clear and targeted arguments will put Applicants in the best position to persuade an Examiner of an invention’s non-obviousness. Rule 132 declarations that do not contain robust data may not be worth the trouble of submitting, as they are unlikely to convince an Examiner or withstand an Appeal.
