Transcript 35 U.S.C. 112 Requirements

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
 General Rule:
 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).