35 U.S.C. 35 U.S.C. § 112, § 112, First ParagraphFirst Paragraph

By:By:Sheetal S. PatelSheetal S. Patel

35 U.S.C. 35 U.S.C. § 112, 1§ 112, 1stst Paragraph Paragraph

General Rule:General Rule:

The specification shall contain a The specification shall contain a written descriptionwritten description of the of the invention, and of the manner and process of making and using it, invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to in such full, clear, concise, and exact terms as to enableenable any any person skilled in the art to which it pertains, or with which it is 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 most nearly connected, to make and use the same, and shall set forth the forth the best modebest mode contemplated by the inventor of carrying out contemplated by the inventor of carrying out his invention.his invention.

Requirements for 35 U.S.C. Requirements for 35 U.S.C. § 112, 1§ 112, 1stst ParagraphParagraph

Two Basic Requirements under the 1Two Basic Requirements under the 1st st Paragraph of 35 U.S.C. Paragraph of 35 U.S.C. § § 112:112:

Written Description RequirementWritten Description Requirement

Enablement RequirementEnablement Requirement

Best Mode RequirementBest Mode Requirement

Policy Underlying 35 U.S.C. Policy Underlying 35 U.S.C. § § 112, 1112, 1stst ParagraphParagraph

To obtain a valid patent, a patent application must be filed that To obtain a valid patent, a patent application must be filed that contains a full and clear disclosure of the invention in the manner contains a full and clear disclosure of the invention in the manner prescribed by 35 U.S.C. prescribed by 35 U.S.C. § § 112, first paragraph. (See MPEP 112, first paragraph. (See MPEP § § 2162).2162).

The requirement for an adequate disclosure ensures that the public The requirement for an adequate disclosure ensures that the public

receives something in return for the exclusionary rights that are receives something in return for the exclusionary rights that are granted to the inventor by a patent. granted to the inventor by a patent.

In exchange for the patent rights granted, 35 U.S.C. In exchange for the patent rights granted, 35 U.S.C. § § 112, first 112, first paragraph, sets forth the minimum requirements for the quality and paragraph, sets forth the minimum requirements for the quality and quantity of information that must be contained in the patent to justify quantity of information that must be contained in the patent to justify the grant. the grant.

General Principles for Written Description General Principles for Written Description RequirementRequirement

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

General Principles (continued)General Principles (continued)

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

General Principle Original ClaimsGeneral Principle Original Claims

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

Requirements to Reject Original ClaimsRequirements to Reject Original Claims

Office’s Burden under MPEP § 2163(III)(A):Office’s Burden under MPEP § 2163(III)(A): The Examiner must have a The Examiner must have a reasonable basisreasonable basis to challenge the to challenge the

adequacy of the written description. The Examiner has the initial adequacy of the written description. The Examiner has the initial burden of presenting by burden of presenting by a preponderance of evidencea preponderance of evidence why a why a person skilled in the art would not recognize in an applicant's person skilled in the art would not recognize in an applicant's disclosure a description of the invention defined by the claims. disclosure a description of the invention defined by the claims. WertheimWertheim, 541 F.2d at 263, 191 USPQ at 97. , 541 F.2d at 263, 191 USPQ at 97.

Requirements to Reject Original ClaimsRequirements to Reject Original Claims

Office’s Burden (Continued):Office’s Burden (Continued):

In rejecting a claim, the examiner must set forth In rejecting a claim, the examiner must set forth express findings of fact express findings of fact regarding the above analysis which support the lack of written regarding the above analysis which support the lack of written description conclusion. These findings should:description conclusion. These findings should:

IdentifyIdentify the claim limitation at issue; and the claim limitation at issue; and

Establish a Establish a prima facieprima facie case by case by providing reasonsproviding reasons why a person why a person skilled in the art at the time the application was filed would not have 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 recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed. claimed in view of the disclosure of the application as filed.

Important NoteImportant Note: A general allegation of "unpredictability in the art" is : A general allegation of "unpredictability in the art" is not a sufficient reason to support a rejection for lack of adequate written not a sufficient reason to support a rejection for lack of adequate written description.description.

Recap for Rejecting Original Claims for Recap for Rejecting Original Claims for Lack of Written DescriptionLack of Written Description

Determine whether Examiner has:Determine whether Examiner has:

Identified the limitation at issue; andIdentified the limitation at issue; and

Provided reasons why a person skilled in the art at the time Provided reasons why a person skilled in the art at the time the application was filed would not have recognized that the the application was filed would not have recognized that the inventor was in possession of the invention as claimed in inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.view of the disclosure of the application as filed.

Things to Do When Examiner failed to Things to Do When Examiner failed to meet Burdenmeet Burden

What to do, if not met:What to do, if not met:

Submit arguments requesting the Examiner to meet his/her Submit arguments requesting the Examiner to meet his/her burden by pointing out why the Examiner has failed to meet burden by pointing out why the Examiner has failed to meet his/her burden.his/her burden.

Request a new Action because the Examiner’s failure to provide Request a new Action because the Examiner’s failure to provide a prima facie case resulted in an incomplete Office Action under a prima facie case resulted in an incomplete Office Action under 37 C.F.R. 37 C.F.R. § § 1.104(b), which states that “the examiner’s action 1.104(b), which states that “the examiner’s action must be complete as to all matters…”.must be complete as to all matters…”.

General Rule:General Rule:

While there is no While there is no in haec verbain haec verba requirement, newly added claim requirement, newly added claim limitations must be limitations must be supportedsupported in the specification through in the specification through expressexpress, , implicitimplicit, or , or inherentinherent disclosure. (MPEP  disclosure. (MPEP § 2163(I)(B)).§ 2163(I)(B)).

General Rule for New/Amended ClaimsGeneral Rule for New/Amended Claims

Office’s Burden under MPEP Office’s Burden under MPEP § 2163.04(I):§ 2163.04(I):

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

Requirements to Reject New/Amended Requirements to Reject New/Amended ClaimsClaims

Requirements to Reject New/Amended Requirements to Reject New/Amended Claims (Continued)Claims (Continued)

Office’s Burden (continued):Office’s Burden (continued):

If Applicant amends the claims and does not point out where and/or how If Applicant amends the claims and does not point out where and/or how the originally filed disclosure supports the amendment(s), the Examiner the originally filed disclosure supports the amendment(s), the Examiner can reject the claim by using a simple statement (see below)can reject the claim by using a simple statement (see below). (MPEP . (MPEP § § 2163.04(I)(B), citing 2163.04(I)(B), citing Hyatt v. DudasHyatt v. Dudas, 492 F.3d 1365, 1370, 83 USPQ2d , 492 F.3d 1365, 1370, 83 USPQ2d 1373, 1376 (Fed. Cir. 2007)).1373, 1376 (Fed. Cir. 2007)).

Sample Statement:Sample Statement:

Applicant has not pointed out where the new (or amended) claim is Applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the supported, nor does there appear to be a written description of the claim limitation ‘___' in the application as filed."claim limitation ‘___' in the application as filed."

General Principle to ApplyGeneral Principle to Apply

Whenever adding a new claim or limitation, the Applicant should Whenever adding a new claim or limitation, the Applicant should point out where in the application support is found for the newly point out where in the application support is found for the newly added claim or limitation.added claim or limitation.

By citing where support is found, the Examiner, when attempting to By citing where support is found, the Examiner, when attempting to set forth a rejection under first paragraph of 35 U.S.C. set forth a rejection under first paragraph of 35 U.S.C. § § 112, has 112, has the burden to prove lack of support for the newly added feature.the burden to prove lack of support for the newly added feature.

Also, by citing where support is found, the Examiner may less likely 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. set forth a rejection under the first paragraph of 35 U.S.C. § 112.§ 112.

Traversing Lack of Adequate Description Traversing Lack of Adequate Description RequirementRequirement

When traversing the written description requirement, keep in mind that:When traversing the written description requirement, keep in mind that:

The Applicant can argue that the disclosure either expressly, implicitly, The Applicant can argue that the disclosure either expressly, implicitly, or inherently support the subject matter of the claim, at issue.or inherently support the subject matter of the claim, at issue.

If the Examiner finds that the record still does not demonstrate that the 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 written description is adequate to support the claim(s), the Examiner is required to:required to:

repeat the rejection under 35 U.S.C. repeat the rejection under 35 U.S.C. § § 112, 1112, 1stst paragraph, paragraph, fully respond to Applicant's rebuttal arguments, and fully respond to Applicant's rebuttal arguments, and properly treat any further showings submitted by Applicant in the properly treat any further showings submitted by Applicant in the

reply. (MPEP reply. (MPEP § 2163(III)(B)).§ 2163(III)(B)).

If Examiner does not fully respond to Applicant’s rebuttal arguments in 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 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.matters under 37 C.F.R. § 1.104(b) and a new Action can be requested.

EnablementEnablement General GuidelinesGeneral Guidelines

The enablement requirement refers to the requirement of 35 The enablement requirement refers to the requirement of 35 U.S.C. U.S.C. § § 112, first paragraph, that the specification describe how 112, first paragraph, that the specification describe how to make and how to use the invention. (See MPEP to make and how to use the invention. (See MPEP § § 2164).2164).

The purpose of the requirement that the specification describe The purpose of the requirement that the specification describe the invention in such terms that one skilled in the art can make 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 and use the claimed invention is to ensure that the invention is communicated to the interested public in a meaningful way. communicated to the interested public in a meaningful way.

Enablement (continued)Enablement (continued) Important Note:Important Note:

The enablement requirement of 35 U.S.C. The enablement requirement of 35 U.S.C. § § 112, first paragraph, 112, first paragraph, is separate and distinct from the description requirement. (See is separate and distinct from the description requirement. (See MPEP MPEP §§ 2164). 2164).

The fact that an additional limitation to a claim may lack The fact that an additional limitation to a claim may lack descriptive support in the disclosure as originally filed does not descriptive support in the disclosure as originally filed does not necessarily mean that the limitation is also not enabled. necessarily mean that the limitation is also not enabled.

Enablement RejectionsEnablement Rejections General Guidelines for Enablement Rejections:General Guidelines for Enablement Rejections:

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

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

There are many factors to be considered when determining whether there is There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is the enablement requirement and whether any necessary experimentation is “undue” (MPEP “undue” (MPEP § 2164.01(a)). § 2164.01(a)).

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

Enablement Rejection (Continued)Enablement Rejection (Continued)

General Guidelines (continued):General Guidelines (continued):

A proper analysis of whether any experimentation is undue A proper analysis of whether any experimentation is undue requires an analysis of requires an analysis of allall of the of the WandsWands factors.  (MPEP factors.  (MPEP § § 2164.01(a)).  2164.01(a)). 

It is improper to conclude that a disclosure is not enabling based It is improper to conclude that a disclosure is not enabling based on an analysis of only one of the above factors while ignoring on an analysis of only one of the above factors while ignoring one or more of the others.  (one or more of the others.  (IdId.). .).

Traversing Enablement RejectionTraversing Enablement Rejection

When traversing enablement rejection: When traversing enablement rejection:

Make sure to indicate whether the Office has met its burden to establish Make sure to indicate whether the Office has met its burden to establish lack of enablement.lack of enablement.

For example: Determine whether a proper analysis was made of For example: Determine whether a proper analysis was made of allall of the of the WandsWands factors, as required by the MPEP.  factors, as required by the MPEP. 

Further advance prosecution of the application, by stating reasons why Further advance prosecution of the application, by stating reasons why the enablement requirement is met under the first paragraph of 35 the enablement requirement is met under the first paragraph of 35 U.S.C. U.S.C. § 112.§ 112.

Caveat: May create prosecution history estoppel.Caveat: May create prosecution history estoppel.

Best ModeBest Mode General GuidelinesGeneral Guidelines

The “Best Mode” requirementThe “Best Mode” requirement is a safeguard against the desire is a safeguard against the desire on the part of some to obtain patent protection without making a on the part of some to obtain patent protection without making a full disclosure as required by the statute. (See MPEP full disclosure as required by the statute. (See MPEP § 2165; § 2165; see alsosee also In re NelsonIn re Nelson, 280 F.2d 172, 126 USPQ 242 (CCPA , 280 F.2d 172, 126 USPQ 242 (CCPA 1960)).1960)).

In other words, the best mode requirement prevents inventors In other words, the best mode requirement prevents inventors from disclosing only what they know to be an inferior from disclosing only what they know to be an inferior embodiment, while retaining the best embodiment for embodiment, while retaining the best embodiment for themselves.themselves.

No Requirement to Explicitly No Requirement to Explicitly Identify the Best ModeIdentify the Best Mode

While it is required that the best mode contemplated by the While it is required that the best mode contemplated by the inventor(s) must be present in the specification, there is no inventor(s) must be present in the specification, there is no requirement that the best mode be explicitly designated as such.requirement that the best mode be explicitly designated as such.

In other words, it is sufficient that the best mode is merely present.In other words, it is sufficient that the best mode is merely present.

ConclusionConclusion The first paragraph of 35 U.S.C. The first paragraph of 35 U.S.C. § 112 requires that the specification § 112 requires that the specification

provide:provide:

An adequate written description of the invention;An adequate written description of the invention;

Enable a person skilled in the art to make and use the invention; Enable a person skilled in the art to make and use the invention; andand

Provide the best mode for practicing the invention that was Provide the best mode for practicing the invention that was contemplated by the inventor(s).contemplated by the inventor(s).