35 U.S.C. § 112, First Paragraph By: Sheetal S. Patel

35 U.S.C. § 112, 1st Paragraph General Rule: The specification shall contain a written description of the invention, and of 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, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Requirements for 35 U.S.C. § 112, 1st Paragraph Two Basic Requirements under the 1st Paragraph of 35 U.S.C. § 112: Written Description Requirement Enablement Requirement Best Mode Requirement

Policy Underlying 35 U.S.C. § 112, 1st Paragraph To obtain a valid patent, a patent application must be filed that contains a full and clear disclosure of the invention in the manner prescribed by 35 U.S.C. § 112, first paragraph. (See MPEP § 2162). The requirement for an adequate disclosure ensures that the public receives something in return for the exclusionary rights that are granted to the inventor by a patent. In exchange for the patent rights granted, 35 U.S.C. § 112, first paragraph, sets forth the minimum requirements for the quality and quantity of information that must be contained in the patent to justify the grant.

General Principles for Written Description Requirement To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. (MPEP § 2163(I), citing Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116).

General Principles (continued) An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. (MPEP § 2163(I), citing Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)).

General Principle Original Claims There is a strong presumption that an adequate written description of the claimed invention is present when the application is filed. (MPEP § 2163(I), citing In re Wertheim, 541 F.2d 257, 263, 191 USPQ 90, 97 (CCPA 1976) ("we are of the opinion that the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims")).

Requirements to Reject Original Claims Office’s Burden under MPEP § 2163(III)(A): The Examiner must have a reasonable basis to challenge the adequacy of the written description. The Examiner has the initial burden of presenting by a preponderance of evidence why a person skilled in the art would not recognize in an applicant's disclosure a description of the invention defined by the claims. Wertheim, 541 F.2d at 263, 191 USPQ at 97.

Requirements to Reject Original Claims Office’s Burden (Continued): In rejecting a claim, the examiner must set forth express findings of fact regarding the above analysis which support the lack of written description conclusion. These findings should: Identify the claim limitation at issue; and Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. Important Note: A general allegation of "unpredictability in the art" is not a sufficient reason to support a rejection for lack of adequate written description.

Recap for Rejecting Original Claims for Lack of Written Description Determine whether Examiner has: Identified the limitation at issue; and Provided reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.

Things to Do When Examiner failed to meet Burden What to do, if not met: Submit arguments requesting the Examiner to meet his/her burden by pointing out why the Examiner has failed to meet his/her burden. Request a new Action because the Examiner’s failure to provide a prima facie case resulted in an incomplete Office Action under 37 C.F.R. § 1.104(b), which states that “the examiner’s action must be complete as to all matters…”.

General Rule for New/Amended Claims While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure. (MPEP § 2163(I)(B)).

Requirements to Reject New/Amended Claims Office’s Burden under MPEP § 2163.04(I): If applicant amends the claims and points out where and/or how the originally filed disclosure supports the amendment(s), and the Examiner finds that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of the filing of the application, the Examiner has the initial burden of presenting evidence or reasoning to explain why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims. (MPEP § 2163(II)(A)).

Requirements to Reject New/Amended Claims (Continued) Office’s Burden (continued): If Applicant amends the claims and does not point out where and/or how the originally filed disclosure supports the amendment(s), the Examiner can reject the claim by using a simple statement (see below). (MPEP § 2163.04(I)(B), citing Hyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007)). Sample Statement: Applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___' in the application as filed."

General Principle to Apply Whenever adding a new claim or limitation, the Applicant should point out where in the application support is found for the newly added claim or limitation. By citing where support is found, the Examiner, when attempting to set forth a rejection under first paragraph of 35 U.S.C. § 112, has the burden to prove lack of support for the newly added feature. Also, by citing where support is found, the Examiner may less likely set forth a rejection under the first paragraph of 35 U.S.C. § 112.

Traversing Lack of Adequate Description Requirement When traversing the written description requirement, keep in mind that: The Applicant can argue that the disclosure either expressly, implicitly, or inherently support the subject matter of the claim, at issue. If the Examiner finds that the record still does not demonstrate that the written description is adequate to support the claim(s), the Examiner is required to: repeat the rejection under 35 U.S.C. § 112, 1st paragraph, fully respond to Applicant's rebuttal arguments, and properly treat any further showings submitted by Applicant in the reply. (MPEP § 2163(III)(B)). If Examiner does not fully respond to Applicant’s rebuttal arguments in the next Action, then the next Action will not be complete as to all matters under 37 C.F.R. § 1.104(b) and a new Action can be requested.

Enablement General Guidelines The enablement requirement refers to the requirement of 35 U.S.C. § 112, first paragraph, that the specification describe how to make and how to use the invention. (See MPEP § 2164). The purpose of the requirement that the specification describe the invention in such terms that one skilled in the art can make and use the claimed invention is to ensure that the invention is communicated to the interested public in a meaningful way.

Enablement (continued) Important Note: The enablement requirement of 35 U.S.C. § 112, first paragraph, is separate and distinct from the description requirement. (See MPEP § 2164). The fact that an additional limitation to a claim may lack descriptive support in the disclosure as originally filed does not necessarily mean that the limitation is also not enabled.

Enablement Rejections General Guidelines for Enablement Rejections: 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).

Enablement Rejection (continued) General Guidelines (Continued) 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” (MPEP § 2164.01(a)). These factors were laid out in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)): Breadth of the claims; Nature of the invention; State of the prior art; Level of ordinary skill in the art; Predictability of the art; Amount of direction provided in the specification; Any working examples; and Quantity of experimentation needed relative to the disclosure.

Enablement Rejection (Continued) General Guidelines (continued): 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.).

Traversing Enablement Rejection When traversing enablement rejection: Make sure to indicate whether the Office has met its burden to establish lack of enablement. For example: Determine whether a proper analysis was made of all of the Wands factors, as required by the MPEP.  Further advance prosecution of the application, by stating reasons why the enablement requirement is met under the first paragraph of 35 U.S.C. § 112. Caveat: May create prosecution history estoppel.

Best Mode General Guidelines The “Best Mode” requirement is a safeguard against the desire on the part of some to obtain patent protection without making a full disclosure as required by the statute. (See MPEP § 2165; see also In re Nelson, 280 F.2d 172, 126 USPQ 242 (CCPA 1960)). In other words, the best mode requirement prevents inventors from disclosing only what they know to be an inferior embodiment, while retaining the best embodiment for themselves.

No Requirement to Explicitly Identify the Best Mode While it is required that the best mode contemplated by the inventor(s) must be present in the specification, there is no requirement that the best mode be explicitly designated as such. In other words, it is sufficient that the best mode is merely present.

Conclusion The first paragraph of 35 U.S.C. § 112 requires that the specification provide: An adequate written description of the invention; Enable a person skilled in the art to make and use the invention; and Provide the best mode for practicing the invention that was contemplated by the inventor(s).