You are here:  Ed9 10.2019 Guidebook  » Appendix V: 35 U.S.C. 112

2164 The Enablement Requirement

MPEP SECTION SUMMARY This section covers the enablement requirement of the first paragraph or paragraph (a) of 35 U.S.C. 112. The specification must be enabling to a person “skilled in the art to which it pertains, or with which it is most nearly connected”. People have to be able to use the invention. The inventor has to know how it works and the specification must clearly convey how to make and use the invention without undue experimentation. The topic of undue experimentation is covers in further details. Essentially, the information contained in the disclosure of an application must be sufficient enough to inform those skilled in the relevant art how to both make and use the claimed invention. 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.

The enablement requirement refers to the requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph that the specification describe how to make and how to use the invention.

• The invention that one skilled in the art must be enabled to make and use is that defined by the claim(s) of the particular application or patent.

The enablement requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, is separate and distinct from the written description requirement.

When the limitation is not described in the specification portion of the application as filed but is in the claims, the limitation in and of itself may enable one skilled in the art to make and use the claimed invention.

MPEP SECTION SUMMARY Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention. In addition, the fact that experimentation may be complex does not necessarily make it undue, if the art typically engages in such experimentation.

  Section Frequency Chart

Key	2 4 6 8 10
2164.01	(a)

MPEP SECTION SUMMARY There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” The specific factors are covered here. In addition, a conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.

The factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is 'undue' include, but are not limited to:

• The breadth of the claims;
  
• The nature of the invention;
  
• The state of the prior art;
  
• The level of one of ordinary skill;
  
• The level of predictability in the art;
  
• The amount of direction provided by the inventor;
  
• The existence of working examples; and
  
• The quantity of experimentation needed to make or use the invention based on the content of the disclosure.

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.

• 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 SECTION SUMMARY 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. Further details on the topic of how to make the claimed invention are covered here.

Failure to disclose other methods by which the claimed invention may be made does not render a claim invalid under 35 U.S.C. 112.

For unstable and transitory chemical intermediates, the “how to make” requirement does not require that the applicant teach how to make the claimed product in stable, permanent or isolatable form.

A key issue that can arise when determining whether the specification is enabling is whether the starting materials or apparatus necessary to make the invention are available.

MPEP SECTION SUMMARY If a statement of utility in the specification contains within it a connotation of how to use, and/or the art recognizes that standard modes of administration are known and contemplated, 35 U.S.C. 112 is satisfied. Further details on expressing how to use the claimed invention are covered here.

It is not necessary to specify the dosage or method of use if it is known to one skilled in the art that such information could be obtained without undue experimentation.

• If one skilled in the art, based on knowledge of compounds having similar physiological or biological activity, would be able to discern an appropriate dosage or method of use without undue experimentation, this would be sufficient to satisfy 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

MPEP SECTION SUMMARY Compliance with the enablement requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, does not turn on whether an example is disclosed. An example may be “working” or “prophetic.” A working example is based on work actually performed. A prophetic example describes an embodiment of the invention based on predicted results rather than work actually conducted or results actually achieved. Further details on the working example are discussed here.

Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.

• But because only an enabling disclosure is required, applicant need not describe all actual embodiments.

I. NONE OR ONE WORKING EXAMPLE

When considering the factors relating to a determination of non-enablement, if all the other factors point toward enablement, then the absence of working examples will not by itself render the invention non-enabled.

• In other words, lack of working examples or lack of evidence that the claimed invention works as described should never be the sole reason for rejecting the claimed invention on the grounds of lack of enablement.
• A single working example in the specification for a claimed invention is enough to preclude a rejection which states that nothing is enabled since at least that embodiment would be enabled.
• However, a rejection stating that enablement is limited to a particular scope may be appropriate.

The presence of only one working example should never be the sole reason for rejecting claims as being broader than the enabling disclosure, even though it is a factor to be considered along with all the other factors.

II. CORRELATION: IN VITRO/IN VIVO

The issue of “correlation” is related to the issue of the presence or absence of working examples.

“Correlation” as used herein refers to the relationship between in vitro or in vivo animal model assays and a disclosed or a claimed method of use. An in vitro or in vivo animal model example in the specification, in effect, constitutes a “working example” if that example “correlates” with a disclosed or claimed method invention.

• If there is no correlation, then the examples do not constitute “working examples.”

III. WORKING EXAMPLES AND A CLAIMED GENUS

For a claimed genus, representative examples together with a statement applicable to the genus as a whole will ordinarily be sufficient if one skilled in the art (in view of level of skill, state of the art and the information in the specification) would expect the claimed genus could be used in that manner without undue experimentation.

MPEP SECTION SUMMARY The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. This section covers further details on the relationship of predictability in the art and the enablement requirement.

The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention.

The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required.

A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements.

MPEP SECTION SUMMARY Before any analysis of enablement can occur, it is necessary for the examiner to construe the claims. For terms that are not well-known in the art, or for terms that could have more than one meaning, it is necessary that the examiner select the definition that he/she intends to use when examining the application, based on his/her understanding of what the applicant intends it to mean, and explicitly sets forth the meaning of the term and the scope of the claim when writing an Office action. Further details on enablement requirements of the examiner are covered here.

  Section Frequency Chart

Key	2 4 6 8 10
2164.04

The minimal requirement is for the examiner to give reasons explaining the uncertainty of the enablement.

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.

MPEP SECTION SUMMARY This section covers the determination of enablement based on evidence as a whole. Once the examiner has weighed all the evidence and established a reasonable basis to question the enablement provided for the claimed invention, the burden falls 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. Further details on overcoming a prima facie case of lack of enablement are briefly discussed here.

  Section Frequency Chart

Key	2 4 6 8 10
2164.05	(a) (b)

The evidence provided to overcome an enablement rejection need not be absolute, but applicant must present argument and/or evidence that the disclosure would have enabled one of ordinary skill in the art to make and use the claimed invention at the time of filing.

 

MPEP SECTION SUMMARY Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The initial inquiry is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains. The nature of the invention becomes the backdrop to determine the state of the art and the level of skill possessed by one skilled in the art.

Information published for the first time after the filing date generally cannot be used to show what was known at the time of filing, and that if a publication demonstrates that those of ordinary skill in the art would find that a particular invention was not enabled years after the filing date, the publication would be evidence that the claimed invention was not possible at the time of filing.

MPEP SECTION SUMMARY The relative skill of those in the art refers to the skill level of those in the art in the technological field to which the claimed invention pertains. Where different arts are involved in the invention, the specification is enabling if it enables persons skilled in each art to carry out the aspect of the invention applicable to their specialty.

MPEP SECTION SUMMARY The quantity of experimentation needed to be performed by one skilled in the art is only one factor involved in determining whether “undue experimentation” is required to make and use the invention. “[A]n extended period of experimentation may not be undue if the skilled artisan is given sufficient direction or guidance.” This section further covers examples of both reasonable and unreasonable experimentation.

  Section Frequency Chart

Key	2 4 6 8 10
2164.06

I. EXAMPLE OF REASONABLE EXPERIMENTATION

In United States v. Telectronics, Inc., the court reversed the findings of the district court for lack of clear and convincing proof that undue experimentation was needed. The court ruled that since one embodiment (stainless steel electrodes) and the method to determine dose/response was set forth in the specification, the specification was enabling. The question of time and expense of such studies, approximately $50,000 and 6-12 months standing alone, failed to show undue experimentation.

II. EXAMPLE OF UNREASONABLE EXPERIMENTATION

In In re Ghiron, functional “block diagrams” were insufficient to enable a person skilled in the art to practice the claimed invention with only a reasonable degree of experimentation because the claimed invention required a “modification to prior art overlap computers,” and because “many of the components which appellants illustrate as rectangles in their drawing necessarily are themselves complex assemblages . . . . It is common knowledge that many months or years elapse from the announcement of a new computer by a manufacturer before the first prototype is available. This does not bespeak of a routine operation but of extensive experimentation and development work. . . .”

MPEP SECTION SUMMARY It is common that doubt arises about enablement because information is missing about one or more essential claim elements or relationships between elements which one skilled in the art could not develop without undue experimentation. In such a case, the examiner should specifically identify what information is missing and why the missing information is needed to provide enablement. This section covers examples of enablement in electrical and mechanical devices or processes and microorganisms.

I. ELECTRICAL AND MECHANICAL DEVICES OR PROCESSES

Enablement serves the dual function of ensuring adequate disclosure of the claimed invention and of preventing claims broader than the disclosed invention.

Broad claim language is used at the peril of losing any claim that cannot be enabled across its full scope.

• An adequate disclosure of a device may require details of how complex components are constructed and perform the desired function.

II. MICROORGANISMS

Patent applications involving living biological products, such as microorganisms, as critical elements in the process of making the invention, present a unique question with regard to availability.

• The issue was raised in a case involving claims drawn to a fermentative method of producing two novel antibiotics using a specific microorganism and claims to the novel antibiotics so produced.
  
  

MPEP SECTION SUMMARY This section covers examples of enablement issues in biological and chemical cases. Several specific examples are outlined here.

 

MPEP SECTION SUMMARY This section covers examples of enablement in computer programming cases. Several examples are covered here.

 

MPEP SECTION SUMMARY The requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph as to how to use the invention is different from the utility requirement of 35 U.S.C. 101. The requirement of 35 U.S.C. 101 is that some specific, substantial, and credible use be set forth for the invention. This section covers instances when the utility requirement is and is not satisfied.

I. WHEN UTILITY REQUIREMENT IS NOT SATISFIED

A. Not Useful or Operative

If a claim fails to meet the utility requirement of 35 U.S.C. 101 because it is shown to be nonuseful or inoperative, then it necessarily fails to meet the how-to-use aspect of the enablement requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

B. Burden on the Examiner

When the examiner concludes that an application claims an invention that is nonuseful, inoperative, or contradicts known scientific principles, the burden is on the examiner to provide a reasonable basis to support this conclusion.

C. Rebuttal by Applicant

If a rejection under 35 U.S.C. 101 has been properly imposed, along with a corresponding rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, the burden shifts to the applicant to rebut the prima facie showing.

II. WHEN UTILITY REQUIREMENT IS SATISFIED

In some instances, the utility of the claimed invention will be provided, but the skilled artisan will not know how to effect that use. In such a case, no rejection will be made under 35 U.S.C. 101, but a rejection will be made under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

MPEP SECTION SUMMARY All questions of enablement are evaluated against the claimed subject matter. The focus of the examination inquiry is whether everything within the scope of the claim is enabled. Accordingly, the first analytical step requires that the examiner determine exactly what subject matter is encompassed by the claims. The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” An enabling disclosure may be set forth by specific example or broad terminology; the exact form of disclosure is not dispositive. When analyzing the enabled scope of a claim, the teachings of the specification must not be ignored because claims are to be given their broadest reasonable interpretation that is consistent with the specification.

  Section Frequency Chart

Key	2 4 6 8 10
2164.08	(c)

 

MPEP SECTION SUMMARY A single means claim, i.e., where a means recitation does not appear in combination with another recited element of means, is subject to an enablement rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.

MPEP SECTION SUMMARY The presence of inoperative embodiments within the scope of a claim does not necessarily render a claim nonenabled. The standard is whether a skilled person could determine which embodiments that were conceived, but not yet made, would be inoperative or operative with expenditure of no more effort than is normally required in the art. Although, typically, inoperative embodiments are excluded by language in a claim (e.g., preamble), the scope of the claim may still not be enabled where undue experimentation is involved in determining those embodiments that are operable.

MPEP SECTION SUMMARY A feature which is taught as critical in a specification and is not recited in the claims should result in a rejection of such claim under the enablement provision section of 35 U.S.C. 112. In determining whether an unclaimed feature is critical, the entire disclosure must be considered. Features which are merely preferred are not to be considered critical.

 

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