I believe that MPEP § 2164.04 is internally inconsistent, not an accurate statement of the law, and confusing. Examiners routinely cite MPEP § 2164.04 for the proposition that they do not have to provide any actual reasoning when rejecting a claim under § 112(a) as lacking enablement. This is not an accurate statement of the law; therefore, I suggest deleting this section. Alternatively, this section could be amended to make it clear that a prima facie case of a lack of enablement is not satisfied until the Wands factors are fully analyzed.
My biggest issue with this section is that it states that "it is not necessary to discuss each factor in the enablement rejection.”
First, I would note that the MPEP lacks a citation to any authority for this statement.
Second, this statement is inconsistent with MPEP § 2164.01(a), which states that “[t]he examiner’s analysis must consider all the evidence related to each of these factors, and any conclusion of nonenablement must be based on the evidence as a whole.” There are two possible interpretations of the interplay between these two sections, wherein one requires the examiner to consider evidence with respect to “each” factor and the other states that an examiner does not need to discuss each factor. The first possibility is that the statements in the two sections are simply wholly at odds with each other. The second possibility is that the MPEP is attempting to draw a distinction between when an examiner needs to “consider” factors of a legal test and when those considerations need to actually be “discuss[ed]” in writing. In other words, MPEP § 2164.04 could be read as countenancing the act of examiners making factual and/or legal determinations and not actually placing those determinations on the record. If this interpretation is what is intended by the USPTO, then I believe that it is a grave misstatement of the law. If an examiner considers factors of a test, but does not actually put those determinations in writing, then it robs the applicant of the ability to respond to those determinations. It is incredibly important for applicants to know whether the examiner actually did consider all of the Wands factors, what factors the examiner did not consider to be pertinent, and why the examiner did not consider those factors to be pertinent. Failing to do that in writing, the rejection would be “arbitrary and capricious” under the Administrative Procedure Act, a standard to which all Actions by the USPTO must adhere under Dickenson v. Zurko, as the applicant would have absolutely no ability to rebut the examiner’s findings since the applicant was never even put on notice as to the fact that the findings had ever even been made by the examiner.
Third, the statement is internally inconsistent within its own section. MPEP § 2164.04 later states in an example that “the examiner should specifically identify what information is missing and why one skilled in the art could not supply the information without undue experimentation.” The term “undue experimentation” is defined by the factors that make up its legal test; how can the examiner explain how a PHOSITA “could not supply the information without undue experimentation” without actually going through the factors that make up the definition of undue experimentation?
I would next note that the case that this section cites for establishing the minimal standards with which examiners are required to comply, In re Bowen, was decided 14 years prior to In re Wands. In re Bowen simply reiterates the fact that the USPTO cannot make rejections without providing any reasoning for the rejection. I do not think that is a controversial statement. However, it is misleading when it is implied that that is the sole test by which enablement rejections are measured. The Federal Circuit stated in In re Wands that although “[t]he term ‘undue experimentation’ does not appear in the statute… it is well established that enablement requires that the specification teach those in the art to make and use the invention without undue experimentation.” In other words, undue experimentation is inextricably intertwined with the concept of enablement and thus a decision on whether claims are enabled cannot be reached without in turn determining whether undue experimentation is required. MPEP § 2164.04 appears to directly contravene this statement by implying that examiners are not actually required to consider the Wands factors.
I believe that § 2164.04 would be less confusing and more accurate if it simply stated that In re Wands is the controlling law on the subject of enablement and to make a proper rejection for lack of enablement, the examiner is required to weigh all of the Wands factors (and any other facts deemed relevant by the examiner) in writing.