`EXAMINING PROCEDURE
`
`Original Ninth Edition, March 2014
`Latest Revision November 2015
`[R-07.2015]
`
`
`
`U.S. DEPARTMENT OF
`COMMERCE
`
`United States Patent and
`Trademark Office
`
`Rev. 07.2015, November 2015
`
`Page 1 of 10
`
`IP Bridge Exhibit 2012
`TSMC v. IP Bridge
`IPR2016-01264
`
`
`
`
`AVAILABILITY
`
`The paperbound format of the Manual was discontinued by the Government Publishing Office ef fective December
`13, 2012. The Manual is available electronically in html and PDF renderings on the USPTO website at
`www.uspto.gov/web/offices/pac/mpep/ . The Office also pro vides a search engine for searching the full text
`of the Manual at http://mpep.uspto.gov/RDMS.
`
`Most hyperlinks from the Manual to internal and external websites are active. For particularly long website
`addresses (URLs), an extra space has been added to the rendered text for readability (especially in the PDF
`rendering). Clicking on a hyperlink will direct the user to the referenced website because the reference link data
`in the source document includes the URL without the extra space; however, copying text that includes the extra
`space and thereafter pasting it in a browser will result in an error.
`
`Previous editions and revisions of the Manual are available from the MPEP Archives page on the USPTO
`website at www.uspto.gov/web/offices/pac/mpep/old/index.htm .
`
`EXPLANATION OF NOTATIONS
`
`Revision Date Indicator. Each section within an MPEP Chapter includes a revision date indicator, e.g.,
`[R-07.2015]. The numbers within the bracket indicate the date the revision cycle for that section was completed,
`which would be July 2015 in the example above. Note that the publication date of the Manual as indicated on
`the title page and on the bottom of the PDF renderings may be later than the date the revision cycle was completed
`because of the time required for clearance processes.
`
`"Pre-AIA." Where the phrase "pre-AIA" is associated with a law or rule, it means that version which was in
`force before the date of the change necessitated by the Leahy-Smith America Invents Act (AIA), Public Law
`112-29, 125 Stat. 284.
`
`"Pre-PLT" or pre-PLT (AIA)." Where the phrase "pre-PLT" or "pre-PLT (AIA)" is associated with a law or
`rule, it means that version which was in force before the date of the change necessitated by the Patent Law
`Treaties Implementation Act of 2012, Title II (Patent Law Treaty Implementation (PLT)), Public Law 112-211,
`126 Stat. 1527 (Dec. 18, 2012). Note that the "pre-PLT (AIA)" designation is used when there is also a "pre-AIA"
`version of the law or rule that still has applicability in limited circumstances.
`
`Five Asterisks. The use of fiv e asterisks in the body of the laws, rules, treaties, and administrative instructions
`indicates a portion of the law, rule, treaty, or administrative instruction which was not reproduced.
`
`First Edition, November 1949
`Second Edition, November 1953
`Third Edition, November 1961
`Fourth Edition, June 1979
`Fifth Edition, August 1983
`Sixth Edition, January 1995
`Seventh Edition, July 1998
`Eighth Edition, August 2001
` Final Re vision, August 2012
`Ninth Edition, March 2014 [R-11.2013]
` Re vised, October 2015 [R-07.2015]
` Re vised, November 2015 [R-07.2015]
`
`Rev. 07.2015, November 2015
`
`Page 2 of 10
`
`
`
`
`
`
`
`
`
`Chapter 2100 Patentability
`
`2101
`-2102
`2103
`2104
`2105
`
`2106
`2106.01
`2107
`
`2107.01
`
`2107.02
`
`2107.03
`
`2108
`-2110
`2111
`
`2111.01
`2111.02
`2111.03
`2111.04
`
`2111.05
`
`2112
`
`2112.01
`
`2112.02
`2113
`2114
`
`2115
`
`2116
`2116.01
`
`2117
`-2120
`2121
`
`2121.01
`
`2121.02
`
`[Reserved]
`
`Patent Examination Process
`Patentable Subject Matter
`Patentable Subject Matter — Living
`Subject Matter
`Patent Subject Matter Eligibility
`[Reserved]
`Guidelines for Examination of
`Applications for Compliance with the
`Utility Requirement
`General Principles Governing Utility
`Rejections
`Procedural Considerations Related to
`Rejections for Lack of Utility
`Special Considerations for Asserted
`Therapeutic or Pharmacological
`Utilities
`[Reserved]
`
`Claim Interpretation; Broadest
`Reasonable Interpretation
`Plain Meaning
`Effect of Preamble
`Transitional Phrases
`“Adapted to,” “Adapted for,”
`“Wherein,” and “Whereby” Clauses
`Functional and Nonfunctional
`Descriptive Material
`Requirements of Rejection Based on
`Inherency; Burden of Proof
`Composition, Product, and Apparatus
`Claims
`Process Claims
`Product-by-Process Claims
`Apparatus and Article Claims —
`Functional Language
`Material or Article Worked Upon by
`Apparatus
`[Reserved]
`Novel, Unobvious Starting Material
`or End Product
`[Reserved]
`
`Prior Art; General Level of Operability
`Required to Make a Prima Facie Case
`Use of Prior Art in Rejections Where
`Operability is in Question
`Compounds and Compositions —
`What Constitutes Enabling Prior Art
`
`2121.03
`
`2121.04
`
`2122
`2123
`
`2124
`
`2124.01
`
`2125
`2126
`
`2126.01
`
`2126.02
`
`2127
`
`2128
`2128.01
`
`2128.02
`
`2129
`2130
`2131
`
`2131.01
`
`2131.02
`2131.03
`2131.04
`2131.05
`
`2132
`2132.01
`
`2133
`2133.01
`
`2133.02
`
`Plant Genetics — What Constitutes
`Enabling Prior Art
`Apparatus and Articles — What
`Constitutes Enabling Prior Art
`Discussion of Utility in the Prior Art
`Rejection Over Prior Art’s Broad
`Disclosure Instead of Preferred
`Embodiments
`Exception to the Rule That the Critical
`Reference Date Must Precede the Filing
`Date
`Tax Strategies Deemed Within the
`Prior Art
`Drawings as Prior Art
`Availability of a Document as a
`“Patent” for Purposes of Rejection
`Under 35 U.S.C. 102(a) or Pre-AIA 35
`U.S.C. 102(a), (b), and (d)
`Date of Availability of a Patent as a
`Reference
`Scope of Reference’s Disclosure
`Which Can Be Used to Reject Claims
`When the Reference Is a “Patent” but
`Not a “Publication”
`Domestic and Foreign Patent
`Applications as Prior Art
`“Printed Publications” as Prior Art
`Level of Public Accessibility
`Required
`Date Publication Is Available as a
`Reference
`Admissions as Prior Art
`[Reserved]
`Anticipation — Application of 35 U.S.C.
`102
`
`Multiple Reference 35 U.S.C. 102
`Rejections
`Genus-Species Situations
`Anticipation of Ranges
`Secondary Considerations
`Nonanalogous or Disparaging Prior
`Art
`Pre-AIA 35 U.S.C. 102(a)
`Publications as Pre-AIA 35 U.S.C.
`102(a) Prior Art
`Pre-AIA 35 U.S.C. 102(b)
`Rejections of Continuation-In-Part
`(CIP) Applications
`Rejections Based on Publications and
`Patents
`
`2100-1
`
`Rev. 07.2015, November 2015
`
`Page 3 of 10
`
`
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`2133.03
`
`2133.03(a)
`2133.03(b)
`2133.03(c)
`2133.03(d)
`2133.03(e)
`
`Rejections Based on “Public Use” or
`“On Sale”
`“Public Use”
`“On Sale”
`The “Invention”
`“In This Country”
`Permitted Activity; Experimental
`Use
`
`2133.03(e)(1)
`2133.03(e)(2)
`2133.03(e)(3)
`
`2133.03(e)(4)
`
`2133.03(e)(5)
`
`2133.03(e)(6)
`
`2133.03(e)(7)
`
`2134
`2135
`2135.01
`
`2136
`2136.01
`
`2136.02
`
`2136.03
`2136.04
`
`2136.05
`
`2137
`2137.01
`2137.02
`
`2138
`2138.01
`2138.02
`
`2138.03
`
`2138.04
`2138.05
`2138.06
`2139
`-2140
`
`Commercial Exploitation
`Intent
`“Completeness” of the
`Invention
`Factors Indicative of an
`Experimental Purpose
`Experimentation and Degree
`of Supervision and Control
`Permitted Experimental
`Activity and Testing
`Activity of an Independent
`Third Party Inventor
`Pre-AIA 35 U.S.C. 102(c)
`Pre-AIA 35 U.S.C. 102(d)
`The Four Requirements of Pre-AIA
`35 U.S.C. 102(d)
`Pre-AIA 35 U.S.C. 102(e)
`Status of U.S. Application as a
`Reference
`Content of the Prior Art Available
`Against the Claims
`Critical Reference Date
`Different Inventive Entity; Meaning
`of “By Another”
`Overcoming a Rejection Under
`Pre-AIA 35 U.S.C. 102(e)
`Pre-AIA 35 U.S.C. 102(f)
`Inventorship
`Applicability of Pre-AIA 35 U.S.C.
`103(c)
`Pre-AIA 35 U.S.C. 102(g)
`Interference Practice
`“The Invention Was Made in This
`Country”
`“By Another Who Has Not
`Abandoned, Suppressed, or
`Concealed It”
`“Conception”
`“Reduction to Practice”
`“Reasonable Diligence”
`[Reserved]
`
`2141
`
`2141.01
`2141.01(a)
`2141.02
`
`2141.03
`2142
`
`2143
`
`2143.01
`
`2143.02
`
`2143.03
`
`2144
`
`2144.01
`2144.02
`2144.03
`
`2144.04
`
`2144.05
`
`2144.06
`
`2144.07
`
`2144.08
`
`2144.09
`
`2145
`
`2146
`2147
`-2149
`2150
`
`2151
`
`2152
`
`Examination Guidelines for
`Determining Obviousness Under 35
`U.S.C. 103
`Scope and Content of the Prior Art
`Analogous and Nonanalogous Art
`Differences Between Prior Art and
`Claimed Invention
`Level of Ordinary Skill in the Art
`Legal Concept of Prima Facie
`Obviousness
`Examples of Basic Requirements of a
`Prima Facie Case of Obviousness
`Suggestion or Motivation To Modify
`the References
`Reasonable Expectation of Success
`Is Required
`All Claim Limitations Must Be
`Considered
`Supporting a Rejection Under 35 U.S.C.
`103
`
`Implicit Disclosure
`Reliance on Scientific Theory
`Reliance on Common Knowledge in
`the Art or “Well Known” Prior Art
`Legal Precedent as Source of
`Supporting Rationale
`Obviousness of Similar and
`Overlapping Ranges, Amounts, and
`Proportions
`Art Recognized Equivalence for the
`Same Purpose
`Art Recognized Suitability for an
`Intended Purpose
`Obviousness of Species When Prior
`Art Teaches Genus
`Close Structural Similarity Between
`Chemical Compounds (Homologs,
`Analogues, Isomers)
`Consideration of Applicant’s Rebuttal
`Arguments
`Pre-AIA 35 U.S.C. 103(c)
`[Reserved]
`
`Examination Guidelines for 35 U.S.C.
`102 and 103 as Amended by the First
`Inventor To File Provisions of the
`Leahy-Smith America Invents Act
`Overview of the Changes to 35 U.S.C.
`102 and 103 in the AIA
`Detailed Discussion of AIA 35 U.S.C.
`102(a) and (b)
`
`Rev. 07.2015, November 2015
`
`2100-2
`
`Page 4 of 10
`
`
`
`PATENTABILITY
`
`2152.01
`
`2152.02
`
`2152.02(a)
`2152.02(b)
`2152.02(c)
`2152.02(d)
`2152.02(e)
`2152.02(f)
`2152.03
`2152.04
`2153
`
`2153.01
`
`2153.01(a)
`
`2153.01(b)
`
`2153.02
`
`2154
`
`2154.01
`
`2154.01(a)
`2154.01(b)
`
`2154.01(c)
`
`2154.02
`
`2154.02(a)
`
`Effective Filing Date of the Claimed
`Invention
`Prior Art Under AIA 35 U.S.C.
`102(a)(1) (Patented, Described in a
`Printed Publication, or in Public Use,
`on Sale, or Otherwise Available to the
`Public)
`Patented
`Described in a Printed Publication
`In Public Use
`On Sale
`Otherwise Available to the Public
`No Requirement of "By Others"
`Admissions
`The Meaning of "Disclosure"
`Prior Art Exceptions Under 35 U.S.C.
`102(b)(1) to AIA 35 U.S.C. 102(a)(1)
`Prior Art Exception Under AIA 35
`U.S.C. 102(b)(1)(A) To AIA 35
`U.S.C. 102(a)(1) (Grace Period
`Inventor Or Inventor-Originated
`Disclosure Exception)
`Grace Period Inventor Disclosure
`Exception
`Grace Period Inventor-Originated
`Disclosure Exception
`Prior Art Exception Under AIA 35
`U.S.C. 102(b)(1)(B) to AIA 35 U.S.C.
`102(a)(1) (Inventor Or
`Inventor-Originated Prior Public
`Disclosure Exception)
`Provisions Pertaining to Subject Matter
`in a U.S. Patent or Application
`Effectively Filed Before the Effective
`Filing Date of the Claimed Invention
`Prior Art Under AIA 35 U.S.C.
`102(a)(2) “U.S. Patent Documents”
`WIPO Published Applications
`Determining When Subject
`Matter Was Effectively Filed
`Under AIA 35 U.S.C. 102(d)
`Requirement Of “Names Another
`Inventor”
`Prior Art Exceptions Under 35 U.S.C.
`102(b)(2) to AIA 35 U.S.C. 102(a)(2)
`Prior Art Exception Under AIA
`35 U.S.C. 102(b)(2)(A) to AIA
`35 U.S.C. 102(a)(2)
`(Inventor-Originated Disclosure
`Exception)
`
`2154.02(b)
`
`2154.02(c)
`
`2155
`
`2155.01
`
`2155.02
`
`2155.03
`
`2155.04
`2155.05
`
`2155.06
`
`2156
`2157
`2158
`2159
`
`2159.01
`
`2159.02
`
`2159.03
`
`2159.04
`
`Prior Art Exception Under AIA
`35 U.S.C. 102(b)(2)(B) to AIA
`35 U.S.C. 102(a)(2) (Inventor or
`Inventor-Originated Prior Public
`Disclosure Exception)
`Prior Art Exception Under AIA
`35 U.S.C. 102(b)(2)(C) to AIA
`35 U.S.C. 102(a)(2) (Common
`Ownership or Obligation of
`Assignment)
`Use of Affida vits or Declarations Under
`37 CFR 1.130 To Overcome Prior Art
`Rejections
`Showing That the Disclosure Was
`Made by the Inventor or a Joint
`Inventor
`Showing That the Subject Matter
`Disclosed Had Been Previously
`Publicly Disclosed by the Inventor or
`a Joint Inventor
`Showing That the Disclosure was
`Made, or That Subject Matter had
`Been Previously Publicly Disclosed,
`by Another Who Obtained the Subject
`Matter Disclosed Directly or
`Indirectly From the Inventor or a Joint
`Inventor
`Enablement
`Who May File an Affida vit or
`Declaration Under 37 CFR 1.130
`Situations in Which an Affida vit or
`Declaration Is Not Available
`Joint Research Agreements
`Improper Naming of Inventors
`AIA 35 U.S.C. 103
`Applicability Date Provisions and
`Determining Whether an Application
`Is Subject to the First Inventor To File
`Provisions of the AIA
`Applications Filed Before March 16,
`2013
`Applications Filed on or After March
`16, 2013
`Applications Subject to the AIA but
`Also Containing a Claimed Invention
`Having an Effective Filing Date
`Before March 16, 2013
`Applicant Statement in Transition
`Applications Containing a Claimed
`Invention Having an Effective Filing
`Date on or After March 16, 2013
`
`2100-3
`
`Rev. 07.2015, November 2015
`
`Page 5 of 10
`
`
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`2160
`2161
`
`2161.01
`
`2162
`
`2163
`
`2163.01
`
`2163.02
`
`2163.03
`
`2163.04
`
`2163.05
`2163.06
`
`2163.07
`
`2163.07(a)
`
`[Reserved]
`Three Separate Requirements for
`Specification Under 35 U .S.C. 112(a) or
`Pre-AIA 35 U.S.C. 112, First Paragraph
`Computer Programming and 35
`U.S.C. 112(a) or Pre-AIA 35 U.S.C.
`112, First Paragraph
`Policy Underlying 35 U.S.C. 112(a) or
`Pre-AIA 35 U.S.C. 112, First Paragraph
`Guidelines for the Examination of
`Patent Applications Under the 35
`U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112,
`para. 1, “Written Description”
`Requirement
`Support for the Claimed Subject
`Matter in Disclosure
`Standard for Determining Compliance
`With the Written Description
`Requirement
`Typical Circumstances Where
`Adequate Written Description Issue
`Arises
`Burden on the Examiner with Regard
`to the Written Description
`Requirement
`Changes to the Scope of Claims
`Relationship of Written Description
`Requirement to New Matter
`Amendments to Application Which
`Are Supported in the Original
`Description
`Inherent Function, Theory, or
`Advantage
`2163.07(b)
`Incorporation by Reference
`The Enablement Requirement
`2164
`2164.01
`Test of Enablement
`2164.01(a)
`Undue Experimentation Factors
`2164.01(b)
`How to Make the Claimed
`Invention
`How to Use the Claimed
`Invention
`Working Example
`Relationship of Predictability of the
`Art and the Enablement Requirement
`Burden on the Examiner Under the
`Enablement Requirement
`Determination of Enablement Based
`on Evidence as a Whole
`Specification Must Be Enabling
`as of the Filing Date
`
`2164.01(c)
`
`2164.02
`2164.03
`
`2164.04
`
`2164.05
`
`2164.05(a)
`
`2164.05(b)
`
`2164.06
`2164.06(a)
`
`2164.06(b)
`
`2164.06(c)
`
`2164.07
`
`2164.08
`
`Specification Must Be Enabling
`to Persons Skilled in the Art
`Quantity of Experimentation
`Examples of Enablement
`Issues-Missing Information
`Examples of Enablement Issues
`— Chemical Cases
`Examples of Enablement Issues
`– Computer Programming Cases
`Relationship of Enablement
`Requirement to Utility Requirement
`of 35 U.S.C. 101
`Enablement Commensurate in Scope
`With the Claims
`2164.08(a)
`Single Means Claim
`2164.08(b)
`Inoperative Subject Matter
`2164.08(c)
`Critical Feature Not Claimed
`2165
`The Best Mode Requirement
`2165.01
`Considerations Relevant to Best Mode
`2165.02
`Best Mode Requirement Compared
`to Enablement Requirement
`Requirements for Rejection for Lack
`of Best Mode
`Examples of Evidence of
`Concealment
`[Reserved]
`
`2165.03
`
`2165.04
`
`2166
`-2170
`2171
`
`2172
`
`2172.01
`2173
`
`2173.01
`2173.02
`
`2173.03
`
`2173.04
`2173.05
`
`Two Separate Requirements for Claims
`Under 35 U.S.C. 112 (b) or Pre-AIA 35
`U.S.C. 112, Second Paragraph
`Subject Matter Which the Inventor or
`a Joint Inventor Regards as The
`Invention
`Unclaimed Essential Matter
`Claims Must Particularly Point Out
`and Distinctly Claim the Invention
`Interpreting the Claims
`Determining Whether Claim
`Language is Definite
`Correspondence Between
`Specification and Claims
`Breadth Is Not Indefiniteness
`Specific Topics Related to Issues
`Under 35 U.S.C. 112(b) or Pre-AIA
`35 U.S.C. 112, Second Paragraph
`New Terminology
`Relative Terminology
`Numerical Ranges and Amounts
`Limitations
`Exemplary Claim Language (“for
`example,” “such as”)
`
`2173.05(a)
`2173.05(b)
`2173.05(c)
`
`2173.05(d)
`
`Rev. 07.2015, November 2015
`
`2100-4
`
`Page 6 of 10
`
`
`
`PATENTABILITY
`
`§ 2103
`
`2173.05(e)
`2173.05(f)
`
`2173.05(g)
`2173.05(h)
`2173.05(i)
`2173.05(j)
`2173.05(k)
`2173.05(l)
`2173.05(m)
`2173.05(n)
`2173.05(o)
`2173.05(p)
`
`2173.05(q)
`2173.05(r)
`2173.05(s)
`2173.05(t)
`2173.05(u)
`
`2173.05(v)
`2173.06
`2174
`
`Lack of Antecedent Basis
`Reference to Limitations in
`Another Claim
`Functional Limitations
`Alternative Limitations
`Negative Limitations
`Old Combination
`Aggregation
`[Reserved]
`Prolix
`Multiplicity
`Double Inclusion
`Claim Directed to Product-By-
`Process or Product and Process
`“Use” Claims
`Omnibus Claim
`Reference to Figures or Tables
`Chemical Formula
`Trademarks or Trade Names in a
`Claim
`Mere Function of Machine
`Practice Compact Prosecution
`Relationship Between the Requirements
`of 35 U.S.C. 112(a) and (b) or Pre-AIA
`35 U.S.C. 112, First and Second
`Paragraphs
`[Reserved]
`
`2175
`-2180
`2181
`
`2182
`
`2183
`
`2184
`
`2185
`
`2186
`
`2187
`-2189
`2190
`
`2101
`
`Identifying and Interpreting a 35 U.S.C.
`112(f) or Pre-AIA 35 U.S.C. 112, Sixth
`Paragraph Limitation
`Search and Identification of the Prior
`Art
`Making a Prima Facie Case of
`Equivalence
`Determining Whether an Applicant Has
`Met the Burden of Proving
`Nonequivalence After a Prima Facie
`Case Is Made
`Related Issues Under 35 U.S.C. 112(a)
`or (b) and Pre-AIA 35 U.S.C. 112, First
`or Second Paragraphs
`Relationship to the Doctrine of
`Equivalents
`[Reserved]
`
`Prosecution Laches
`
`-2102 [Reserved]
`
`2103 Patent Examination Process
`[R-07.2015]
`
`I. DETERMINE WHAT APPLICANT HAS
`INVENTED AND IS SEEKING TO PATENT
`
`It is essential that patent applicants obtain a prompt
`yet complete examination of their applications.
`Under the principles of compact prosecution, each
`claim should be reviewed for compliance with every
`statutory requirement for patentability in the initial
`review of the application, even if one or more claims
`are found to be deficient with respect to some
`statutory requirement. Thus, USPTO personnel
`should state all reasons and bases for rejecting claims
`in the first Office action. Deficiencies should be
`explained clearly, particularly when they serve as a
`basis for a rejection. Whenever practicable, USPTO
`personnel should indicate how rejections may be
`overcome and how problems may be resolved. A
`failure to follow this approach can lead to
`unnecessary delays in the prosecution of the
`application.
`
`Prior to focusing on specific statutory requirements,
`USPTO personnel must begin examination by
`determining what, precisely, the applicant has
`invented and is seeking to patent, and how the claims
`relate to and define that in vention. USPTO personnel
`will review the complete specification, including the
`detailed description of the invention, any specific
`embodiments that have been disclosed, the claims
`and any specific, substantial, and credible utilities
`that have been asserted for the invention.
`
`After obtaining an understanding of what applicant
`invented, the examiner will conduct a search of the
`prior art and determine whether the invention as
`claimed complies with all statutory requirements.
`
`A. Identify and Understand Any Utility for the
`Invention
`
`The claimed invention as a whole must be useful.
`The purpose of this requirement is to limit patent
`protection to inventions that possess a certain level
`of “real world” value, as opposed to subject matter
`
`2100-5
`
`Rev. 07.2015, November 2015
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`Page 7 of 10
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`
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`PATENTABILITY
`
`§ 2111.03
`
`referring to “punching and connecting” function of
`invention did not constitute “clear reliance” on the
`preamble needed to make the preamble a limitation).
`
`2111.03 Transitional Phrases [R-08.2012]
`
`The transitional phrases “comprising”, “consisting
`essentially of” and “consisting of” define the scope
`of a claim with respect to what unrecited additional
`components or steps, if any, are excluded from the
`scope of the claim. The determination of what is or
`is not excluded by a transitional phrase must be made
`on a case-by-case basis in light of the facts of each
`case.
`
`The transitional term “comprising”, which is
`synonymous with “including,” “containing,” or
`“characterized by,” is inclusive or open-ended and
`does not exclude additional, unrecited elements or
`method steps. See, e.g., Mars Inc. v. H.J. Heinz Co.,
`377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed.
`Cir. 2004) (“[L]ike the term ‘comprising,’ the terms
`‘containing’ and ‘mixture’ are open-ended.”).
` Invitrogen Corp. v. Biocrest Manufacturing, L.P.,
`327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed.
`Cir. 2003) (“The transition ‘comprising’ in a method
`claim indicates that the claim is open-ended and
`allows for additional steps.”); Genentech, Inc. v.
`Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608,
`1613 (Fed. Cir. 1997) (“Comprising” is a term of art
`used in claim language which means that the named
`elements are essential, but other elements may be
`added and still form a construct within the scope of
`the claim.); Moleculon Research Corp. v. CBS, Inc.,
`793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In
`re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803
`(CCPA 1981); Ex parte Davis, 80 USPQ 448, 450
`(Bd. App. 1948) (“comprising” leaves “the claim
`open for the inclusion of unspecified ingredients
`even in major amounts”). In Gillette Co. v.
`Energizer Holdings Inc., 405 F.3d 1367, 1371-73,
`74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the
`court held that a claim to “a safety razor blade unit
`comprising a guard, a cap, and a group of first,
`second, and third blades” encompasses razors with
`more than three blades because the transitional
`phrase “comprising” in the preamble and the phrase
`“group of” are presumptively open-ended. “The word
`‘comprising’ transitioning from the preamble to the
`body signals that the entire claim is presumptively
`
`open-ended.” Id. In contrast, the court noted the
`phrase “group consisting of” is a closed term, which
`is often used in claim drafting to signal a “Markush
`group” that is by its nature closed. Id. The court also
`emphasized that reference to “first, ” “second,” and
`“third” blades in the claim was not used to show a
`serial or numerical limitation but instead was used
`to distinguish or identify the various members of the
`group. Id.
`
`The transitional phrase “consisting of” excludes any
`element, step, or ingredient not specified in the
`claim. In re Gray, 53 F.2d 520, 11 USPQ 255
`(CCPA 1931); Ex parte Davis, 80 USPQ 448, 450
`(Bd. App. 1948) (“consisting of” defined as “closing
`the claim to the inclusion of materials other than
`those recited except for impurities ordinarily
`associated therewith”). But see Norian Corp. v.
`Stryker Corp., 363 F.3d 1321, 1331-32, 70 USPQ2d
`1508, 1516 (Fed. Cir. 2004) (holding that a bone
`repair kit “consisting of” claimed chemicals was
`infringed by a bone repair kit including a spatula in
`addition to the claimed chemicals because the
`presence of the spatula was unrelated to the claimed
`invention). A claim which depends from a claim
`which “consists of” the recited elements or steps
`cannot add an element or step. When the phrase
`“consists of” appears in a clause of the body of a
`claim, rather than immediately following the
`preamble, it limits only the element set forth in that
`clause; other elements are not excluded from the
`claim as a whole.
` Mannesmann Demag
`Corp. v. Engineered Metal Products Co., 793 F.2d
`1279, 230 USPQ 45 (Fed. Cir. 1986). See also In
`re Crish, 393 F.3d 1253, 73 USPQ2d 1364 (Fed.
`Cir. 2004) (The claims at issue “related to purified
`DNA molecules having promoter activity for the
`human involucrin gene (hINV).” Id., 73 USPQ2d
`at 1365. In determining the scope of applicant’s
`claims directed to “a purified oligonucleotide
`comprising at least a portion of the nucleotide
`sequence of SEQ ID NO:1 wherein said portion
`consists of the nucleotide sequence from … to 2473
`of SEQ ID NO:1, and wherein said portion of the
`nucleotide sequence of SEQ ID NO:1 has promoter
`activity,” the court stated that the use of “consists”
`in the body of the claims did not limit the
`open-ended “comprising” language in the claims
`(emphases added). Id. at 1257, 73 USPQ2d at 1367.
`The court held that the claimed promoter sequence
`
`2100-45
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`Rev. 07.2015, November 2015
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`Page 8 of 10
`
`
`
`§ 2111.03
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`designated as SEQ ID NO:1 was obtained by
`sequencing the same prior art plasmid and was
`therefore anticipated by the prior art plasmid which
`necessarily possessed the same DNA sequence as
`the claimed oligonucleotides. Id. at 1256 and 1259,
`73 USPQ2d at 1366 and 1369. The court affirmed
`the Board’s interpretation that the transition phrase
`“consists” did not limit the claims to only the recited
`numbered nucleotide sequences of SEQ ID NO:1
`and that “the transition language ‘comprising’
`allowed the claims to cover the entire involucrin
`gene plus other portions of the plasmid, as long as
`the gene contained the specific portions of SEQ ID
`NO:1 recited by the claim[s].” Id. at 1256, 73
`USPQ2d at 1366.).
`
`The transitional phrase “consisting essentially of”
`limits the scope of a claim to the specified materials
`or steps “and those that do not materially affect the
`basic and novel characteristic(s)” of the claimed
`invention. In re Herz, 537 F.2d 549, 551-52,
`190 USPQ 461, 463 (CCPA 1976) (emphasis in
`original) (Prior art hydraulic fluid required a
`dispersant which appellants argued was excluded
`from claims limited to a functional fluid “consisting
`essentially of” certain components. In finding the
`claims did not exclude the prior art dispersant, the
`court noted that appellants’ specification indicated
`the claimed composition can contain any well-known
`additive such as a dispersant, and there was no
`evidence that the presence of a dispersant would
`materially affect the basic and novel characteristic
`of the claimed invention. The prior art composition
`had the same basic and novel characteristic
`(increased oxidation resistance) as well as additional
`enhanced detergent and dispersant characteristics.).
`“A ‘consisting essentially of’ claim occupies a
`middle ground between closed claims that are written
`in a ‘consisting of’ format and fully open claims that
`are drafted in a ‘comprising’ format.” PPG
`Industries v. Guardian Industries, 156 F.3d 1351,
`1354, 48 USPQ2d 1351, 1353-54 (Fed. Cir. 1998).
`See also Atlas Powder v. E.I. duPont de Nemours
`& Co., 750 F.2d 1569, 224 USPQ 409 (Fed. Cir.
`1984); In re Janakirama-Rao, 317 F.2d 951,
`137 USPQ 893 (CCPA 1963); Water Technologies
`Corp. vs. Calco, Ltd., 850 F.2d 660, 7 USPQ2d 1097
`(Fed. Cir. 1988). For the purposes of searching for
`and applying prior art under 35 U.S.C. 102 and 103,
`absent a clear indication in the specification or
`
`claims of what the basic and novel characteristics
`actually are, “consisting essentially of” will be
`construed as equivalent to “comprising.” See, e.g.,
` PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 (“PPG
`could have defined the scope of the phrase
`‘consisting essentially of’ for purposes of its patent
`by making clear in its specification what it re garded
`as constituting a material change in the basic and
`novel characteristics of the invention.”). See also
` AK Steel Corp. v. Sollac, 344 F.3d 1234, 1240-41,
`68 USPQ2d 1280, 1283-84 (Fed. Cir. 2003)
`(Applicant’s statement in the specification that
`“silicon contents in the coating metal should not
`exceed about 0.5% by weight” along with a
`discussion of the deleterious effects of silicon
`provided basis to conclude that silicon in excess of
`0.5% by weight would materially alter the basic and
`novel properties of the invention. Thus, “consisting
`essentially of” as recited in the preamble was
`interpreted to permit no more than 0.5% by weight
`of silicon in the aluminum coating.); In re
`Janakirama-Rao, 317 F.2d 951, 954, 137 USPQ
`893, 895-96 (CCPA 1963). If an applicant contends
`that additional steps or materials in the prior art are
`excluded by the recitation of “consisting essentially
`of,” applicant has the burden of showing that the
`introduction of additional steps or components would
`materially change the characteristics of applicant’s
`invention. In re De Lajarte, 337 F.2d 870, 143
`USPQ 256 (CCPA 1964). See also Ex parte
`Hoffman, 12 USPQ2d 1061, 1063-64 (Bd. Pat. App.
`& Inter. 1989) (“Although ‘consisting essentially
`of’ is typically used and defined in the conte xt of
`compositions of matter, we find nothing intrinsically
`wrong with the use of such language as a modifier
`of method steps. . . [rendering] the claim open only
`for the inclusion of steps which do not materially
`affect the basic and novel characteristics of the
`claimed method. To determine the steps included
`versus excluded the claim must be read in light of
`the specification. . . . [I]t is an applicant’ s burden to
`establish that a step practiced in a prior art method
`is excluded from his claims by ‘consisting essentially
`of’ language.”).
`
`OTHER TRANSITIONAL PHRASES
`
`Transitional phrases such as “having” must be
`interpreted in light of the specification to determine
`whether open or closed claim language is intended.
`
`Rev. 07.2015, November 2015
`
`2100-46
`
`Page 9 of 10
`
`
`
`PATENTABILITY
`
`§ 2111.05
`
`See, e.g., Lampi Corp. v. American Power Products
`Inc., 228 F.3d 1365, 1376, 56 USPQ2d 1445, 1453
`(Fed. Cir. 2000) (interpreting the term “having” as
`open terminology, allowing the inclusion of other
`components in addition to those recited); Crystal
`Semiconductor Corp. v. TriTech Microelectronics
`Int’l Inc., 246 F.3d 1336, 1348, 57 USPQ2d 1953,
`1959 (Fed. Cir. 2001) (term “having” in transitional
`phrase “does not create a presumption that the body
`of the claim is open”); Regents of the Univ. of Cal.
`v. Eli Lilly & Co., 119 F.3d 1559, 1573, 43 USPQ2d
`1398, 1410 (Fed. Cir. 1997) (in the context of a
`cDNA having a sequence coding for human PI, the
`term “having” still permitted inclusion of other
`moieties). The transitional phrase “composed of”
`has been interpreted in the same manner as either
`“consisting of” or “consisting essentially of,”
`depending on the facts of the particular case. See
` AFG Industries, Inc. v. Cardinal IG Company, 239
`F.3d 1239, 1245, 57 USPQ2d 1776, 1780-81 (Fed.
`Cir. 2001) (based on specification and other
`evidence, “composed of” interpreted in same manner
`as “consisting essentially of”); In re Bertsch, 132
`F.2d 1014, 1019-20, 56 USPQ 379, 384 (CCPA
`1942) (“Composed of” interpreted in same manner
`as “consisting of”; however, the court further
`remarked that “the words ‘composed of’ may under
`certain circumstances be given, in patent law, a
`broader meaning than ‘consisting of.’”).
`
`2111.04 “Adapted to,” “Adapted for,”
`“Wherein,” and “Whereby” Clauses
`[R-07.2015]
`
`Claim scope is not limited by claim language that
`suggests or makes optional but does not require steps
`to be performed, or by claim language that does not
`limit a claim to a particular structure. However,
`examples of claim
`language, although not
`exhaustive, that may raise a question as to the
`limiting effect of the language in a claim are:
`
`(A) “adapted to” or “adapted for” clauses;
`(B) “wherein” clauses; and
`(C) “whereby” clauses.
`
`The determination of whether each of these clauses
`is a limitation in a claim depends on the specific
`facts of the case. See, e.g., Griffin v . Bertina, 283
`F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002)
`
`(finding that a “wherein” clause limited a process
`claim where the clause gave “meaning and purpose
`to the manipulative steps”). In In re Giannelli, 739
`F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed.
`Cir. 2014), the court found that an "adapted to"
`clause limited a machine claim where "the written
`description makes clear that 'adapted to,' as used in
`the [patent] application, has a narrower meaning,
`viz., that the claimed machine is designed or
`constructed to be used as a rowing machine whereby
`a pulling force is exerted on the handles." In Hoffer
`v. Microsoft Corp., 405 F.3d 1326, 1329, 74
`USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held
`that when a “‘whereby’ clause states a condition that
`is material to patentability, it cannot be ignored in
`order to change the substance of the invention.” Id.
`However, the court noted that a “‘whereby clause
`in a method claim is not given weight when it simply
`expresses the intended result of a process step
`positively recited.’” Id. (quoting Minton v. Nat’l
`Ass’n of Securities Dealers, Inc., 336 F.3d 1373,
`1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
`
`2111.05 Functional and Nonfunctional
`Descriptive Material [R-07.2015]
`
`USPTO personnel must consider all claim limitations
`when determining patentability of an invention over
`the prior art. In re Gulack, 703 F.2d 1381, 1385,
`217 USPQ 401, 403-04 (Fed. Cir. 1983). Since a
`claim must be read as a whole, USPTO personnel
`may not disregard claim limitation