35 USC. 112, 1st paragraph (written description, enablement and best mode requirements) – “The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such a full clear, concise, and exact terms so to enable any person skilled in the art to which it pertains…to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.”
1) Written Description
The written description requirement is intended to make clear what the applicant invented and who actually created the invention. Ask yourself, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claims?”
No New Matter: “New matter” cannot be added by amendment to an applicant’s disclosure after its filing [35 USC §§ 132, 251]. The issue of new matter will arise if the claims, specification or drawings of an application are amended and the content of the amendment is not described in the application (i.e. is new matter not already contained in the claims, specification or drawings). Rewording, making inherent function explicit, making explicit material incorporated by reference not new matter.
- Amendment Affecting a Claim – Additional material introduced to an application as 1) an amendment (e.g., to the specification or claims) or 2) a new claim must be supported by the written description as filed. No new matter. An amendment to correct an obvious error does not constitute new matter where one skilled in the art would not only recognize the existence of the error, but also recognize the appropriate correction.
- Reliance on Filing Date of Patent – For claims to be entitled to the filing date of an earlier application, the description of their subject matter must meet §112, paragraph 1 requirements.
- Reliance on Priority – Claims are entitled to the foreign priority date of filing date of a provisional application if the foreign or provisional application supports the claims as required by § 112, paragraph 1.
- Changes to the Scope of the Claim – Broadening or narrowing the breadth of the claim limitations or altering a numerical range limitation after the application has been filed often results in failure to meet the written description requirement. (This is often tested as ranges given in the original specification. For example, the original specification includes ranges of 25%-75% with examples of 40% and 50%. A new claim with “at least 30% is not supported by the original claim.)
The specification must describe to one skilled in the art how to make and use the invention as of the filing date. Enablement may not be met and the application may face a §112, paragraph 1 (lack of enablement) rejection if any of the following conditions (A-C) are met.
A. Requires Undue Experimentation – The test for adequate enablement (determined by the Supreme Court) has been a question of whether a person skilled in the art would have to conduct undue experimentation to make and use the invention.
Actual reduction to practice is not a necessary requirement for filing an application so long as the specification enables one of ordinary skill in the art to make and use the invention without undue experimentation.
Complex experimentation does not necessarily make it undue if the art typically engages in like experimentation. Routine or reasonable experimentation may not be undue. Often enablement will not be met because information (that could not be discovered without undue experimentation) is missing about critical parts of an invention, how to obtain those parts, or the relationship between them.
The following factors are among those to be used for determining whether necessary experimentation is “undue:”
1) The breadth of the claims;
2) The nature of the invention;
3) The state of the prior art; and
4) The level of one of ordinary skill.
B. Claims are Overly Broad – If the specification clearly recites a feature of the invention that is critical to the invention performing its intended operation, and the feature is not recited in the claims, (“purposely” making the claims broader than the enabling disclosure) a rejection based on lack of enablement will be made.
C. Fails the Utility Requirement – Relationship of enablement to the utility requirement: If a claim is not useful or inoperative (i.e., fails to meet the utility requirement) it necessarily fails to meet how-to-use requirement of enablement because the specification cannot show how to use a useless invention.
3) Best Mode
The best mode requirement is intended to ensure that the inventor does not disclose less than the most desirable form of his invention. The examiner should assume that the best mode is in fact disclosed, unless evidence arises to the contrary. In determining the adequacy of a best mode disclosure only evidence of concealment is relevant. Concealment need not be intentional. For example, the quality of the applicant’s best mode may be so poor as to effectively result in concealment.
Disclosure of less than the best mode does not invalidate a parent as long as the inventor as the time of the application did not know of the better method or did not recognize its superiority.
- A specific example is not required to fulfill the requirement – a preferred range of conditions, for instance, may be adequate;
- The disclosure need not point out which of the embodiments is considered best, as long as it is included among those disclosed;
- There is no need to update the believed best mode if priority or the filing date of a previous application is relied upon;
- The failure to disclose the best mode in the original application cannot be rectified with an amendment to the application.