Wednesday, April 1, 2009

Factors in determining enablement--the Wands factors

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The Basis for the Enablement Requirement

The enablement requirement arises from the first paragraph of 35 U.S.C. § 112, which states in relevant part:

[t]he specification shall contain a written description of the invention, and the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same . . .

The purpose of the enablement requirement is to ensure that patented inventions are communicated to the public in a meaningful way.

Fundamentals of the Enablement Requirement

1. The USPTO’s guidelines for examination of patent applications for compliance with the enablement requirement are found in Section 2164 of the MPEP. This should be an Applicant’s primary resource for authority when articulating responses to enablement rejections.

2. All questions of enablement are evaluated against claimed subject matter. (MPEP 2164.08).

3. The test for enablement is whether one of ordinary skill would need to engage in undue experimentation to practice the claimed invention. (MPEP 2164.01).

4. Whether experimentation is “undue” is determined based on the following eight Wands factors:

1. Breadth of the claims;
2. Nature of the invention;
3. State of the prior art;
4. Level of ordinary skill in the art;
5. Predictability of the art;
6. Amount of direction provided in the specification;
7. Any working examples; and
8. Quantity of experimentation needed relative to the disclosure.

(MPEP 2164.01(a), citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)).

5. A proper analysis of whether any experimentation is undue requires an analysis of all of the Wands factors. (MPEP 2164.01(a)). It is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring one or more of the others. (Id.).

6. The amount of guidance or direction needed to satisfy the enablement requirement is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. (MPEP 2164.03). Thus, the question of enablement is one of predictability in view of what is known in the art.

Additional Points

1. The fact that experimentation may be complex does not necessarily make it undue, if the art typically engages in such experimentation. (MPEP 2164.01).

2. A patent need not teach, and preferably omits, what is well known in the art. (MPEP 2164.01). Further, an Applicant need not “enable one of ordinary skill in the art to make and use a perfected, commercially viable embodiment absent a claim limitation to that effect.” (MPEP 2164).

3. Any part of the specification can support an enabling disclosure, even a background section that discusses, or even disparages, the subject matter disclosed therein. (MPEP 2164.01, citing Callicrate v. Wadsworth Mfg., Inc., 427 F.3d 1361, 77 USPQ2d 1041 (Fed. Cir. 2005)(discussion of problems with a prior art feature does not mean that one of ordinary skill in the art would not know how to make and use this feature)).

4. The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without undue experimentation. (MPEP 2164.02).

5. As long as the specification discloses at least one method for making and using the claimed invention that bears a reasonable correlation to the entire scope of the claim, then the enablement requirement of 35 U.S.C. 112 is satisfied. (MPEP 2164.01(b)).

6. Claims must be enabled as of their filing date. (MPEP 2164.05(a)).

7. Enablement is judged from the perspective of an ordinarily skilled artisan. (MPEP 2164.05(b)).

The Office’s Burden

1. It is always incumbent on an Examiner to fully develop the reasons for a technical rejection (enablement, written description, etc.).

Section 706.03 of the MPEP warns Examiners that “[w]here a major technical rejection is proper (e.g., lack of proper disclosure, undue breadth, utility, etc.) such rejection should be stated with a full development of the reasons rather than by a mere conclusion coupled with some stereotyped expression.” Thus, mere conclusory statements are insufficient to support a rejection under Section 112. Consequently, the Office must arguably provide a reasonable basis to reject a claim for failing to satisfy the enablement requirement, and this requires “a full development” of the reasons for the rejection.

This obligation to establish a prima facie case is affirmed by the MPEP in its discussions of each requirement of the first paragraph of 35 U.S.C. § 112. (See, e.g., MPEP § 2163 (III)(A) (written description); MPEP § 2164.04 (enablement)). A prima facie case requires a reasonable basis to challenge the adequacy of the written description. (MPEP § 2164.04).

In accordance with the principles of compact prosecution, if an enablement rejection is appropriate, the first Office action on the merits should present the best case with all the relevant reasons, issues, and evidence so that all such rejections can be withdrawn if applicant provides appropriate convincing arguments and/or evidence in rebuttal. The principles of compact prosecution also dictate that if an enablement rejection is appropriate and the examiner recognizes limitations that would render the claims enabled, the examiner should note such limitations to applicant as early in the prosecution as possible. (MPEP 2164.04).

2. An Examiner should always look for enabled, allowable subject matter and communicate to applicant what that subject matter is at the earliest point possible in the prosecution of the application. (MPEP 2164.04). Thus, if a rejection is made based on the view that the enablement is not commensurate in scope with the claim, the examiner should identify the subject matter that is considered to be enabled. (MPEP 2164.08).

3. The 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. (MPEP 2164.01(a)).

4. Only after the Examiner has weighed all the evidence and established a reasonable basis to question the enablement provided for the claimed invention, does the burden fall on applicant to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would be able to make and use the claimed invention using the application as a guide. (MPEP 2164.05). The evidence provided by applicant need not be conclusive but merely convincing to one skilled in the art. (Id.).

5. The MPEP instructs Examiners that they must assume compliance with the enablement requirement when an application includes a teaching of how to make and use invention “in terms which correspond in scope to the claims.” This mandate may be only ignored when there is a basis to doubt the objective truth of the teaching. (MPEP 2164.04).

So, unless a rejection articulates “evidence or some technical reasoning” that either (i) an enabling teaching does not correspond to the claims or (ii) a reason to doubt the objective truth of such a teaching, the mere presence of a teaching requires that the Office assume that this requirement is satisfied.

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