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
`
`IPR2017-00042
`Bayer Ex. 2009
`
`

`

`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
`
`IPR2017-00042
`Bayer Ex. 2009
`
`

`

`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 Affidavits 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 Affidavit or
`Declaration Under 37 CFR 1.130
`Situations in Which an Affidavit 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
`
`IPR2017-00042
`Bayer Ex. 2009
`
`

`

`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
`
`[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
`2164
`The Enablement Requirement
`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
`
`2163.07(a)
`
`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
`
`IPR2017-00042
`Bayer Ex. 2009
`
`

`

`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 invention. 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
`
`IPR2017-00042
`Bayer Ex. 2009
`
`

`

`§ 2103
`
`MANUAL OF PATENT EXAMINING PROCEDURE
`
`that represents nothing more than an idea or concept,
`or is simply a starting point for future investigation
`or research (Brenner v. Manson, 383 U.S. 519,
`528-36, 148 USPQ 689, 693-96 (1966); In re Fisher,
`421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005);
` In re Ziegler, 992 F.2d 1197, 1200-03, 26 USPQ2d
`1600, 1603-06 (Fed. Cir. 1993)).
`
`USPTO personnel should review the application to
`identify any asserted utility. The applicant is in the
`best position to explain why an invention is believed
`useful. Accordingly, a complete disclosure should
`contain some indication of the practical application
`for the claimed invention, i.e., why the applicant
`believes the claimed invention is useful. Such a
`statement will usually explain the purpose of the
`invention or how the invention may be used (e.g., a
`compound is believed to be useful in the treatment
`of a particular disorder). Regardless of the form of
`statement of utility, it must enable one ordinarily
`skilled in the art to understand why the applicant
`believes the claimed invention is useful. See MPEP
`§ 2107 for utility examination guidelines. An
`applicant may assert more than one utility and
`practical application, but only one is necessary.
`Alternatively, an applicant may rely on
`the
`contemporaneous art to provide that the claimed
`invention has a well-established utility.
`
`B. Review the Detailed Disclosure and Specific
`Embodiments of the Invention To Understand What the
`Applicant Has Invented
`
`The written description will provide the clearest
`explanation of
`the applicant’s
`invention, by
`exemplifying the invention, explaining how it relates
`to the prior art and explaining the relative
`significance of various features of the invention.
`Accordingly, USPTO personnel should continue
`their evaluation by
`
` (A) determining the function of the invention,
`that is, what the invention does when used as
`disclosed (e.g., the functionality of a programmed
`computer); and
` (B) determining the features necessary to
`accomplish at least one asserted practical application.
`
`Patent applicants can assist the USPTO by preparing
`applications that clearly set forth these aspects of an
`invention.
`
`C. Review the Claims
`
`The claims define the property rights provided by a
`patent, and thus require careful scrutiny. The goal
`of claim analysis is to identify the boundaries of the
`protection sought by the applicant and to understand
`how the claims relate to and define what the
`applicant has indicated is the invention. USPTO
`personnel must first determine the scope of a claim
`by thoroughly analyzing the language of the claim
`before determining if the claim complies with each
`statutory requirement for patentability. See In re
`Hiniker Co., 150 F.3d 1362, 1369, 47 USPQ2d 1523,
`1529 (Fed. Cir. 1998) (“[T]he name of the game is
`the claim.”).
`
`USPTO personnel should begin claim analysis by
`identifying and evaluating each claim limitation. For
`processes, the claim limitations will define steps or
`acts to be performed. For products, the claim
`limitations will define discrete physical structures
`or materials. Product claims are claims that are
`directed to either machines, manufactures or
`compositions of matter.
`
`USPTO personnel are to correlate each claim
`limitation to all portions of the disclosure that
`describe the claim limitation. This is to be done in
`all cases, regardless of whether the claimed invention
`is defined using means- (or step-) plus- function
`language. The correlation step will ensure that
`USPTO personnel correctly interpret each claim
`limitation.
`
`The subject matter of a properly construed claim is
`defined by the terms that limit its scope. It is this
`subject matter that must be examined. As a general
`matter, the grammar and intended meaning of terms
`used in a claim will dictate whether the language
`limits the claim scope. Language that suggests or
`makes optional but does not require steps to be
`performed or does not limit a claim to a particular
`structure does not limit the scope of a claim or claim
`limitation. The following are examples of language
`that may raise a question as to the limiting effect of
`the language in a claim:
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` (A) statements of intended use or field of use,
` (B) “adapted to” or “adapted for” clauses,
` (C) "wherein" clauses, or
` (D) “whereby” clauses.
`
`This list of examples is not intended to be
`exhaustive. The determination of whether particular
`language is a limitation in a claim depends on the
`specific facts of the case. See, e.g., Griffin v.
`Bertina, 285 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”).
`See also MPEP §§ 2111.02 and 2111.04.
`
`USPTO personnel are to give claims their broadest
`reasonable interpretation in light of the supporting
`disclosure. See MPEP § 2111. Disclosure may be
`express, implicit, or inherent. USPTO personnel are
`to give the claimed means- (or step-) plus- function
`limitations their broadest reasonable interpretation
`consistent with all corresponding structures or
`materials described in the specification and their
`equivalents including the manner in which the
`claimed functions are performed. See Kemco Sales,
`Inc. v. Control Papers Company, Inc., 208 F.3d
`1352, 54 USPQ2d 1308 (Fed. Cir. 2000). Further
`guidance in interpreting the scope of equivalents is
`provided in MPEP § 2181 through MPEP § 2186.
`
`While it is appropriate to use the specification to
`determine what applicant intends a term to mean, a
`positive limitation from the specification cannot be
`read into a claim that does not itself impose that
`limitation. A broad interpretation of a claim by
`USPTO personnel will reduce the possibility that
`the claim, when issued, will be interpreted more
`broadly than is justified or intended. An applicant
`can always amend a claim during prosecution to
`better reflect the intended scope of the claim.
`
`Finally, when evaluating the scope of a claim, every
`limitation in the claim must be considered. USPTO
`personnel may not dissect a claimed invention into
`discrete elements and then evaluate the elements in
`isolation. Instead, the claim as a whole must be
`considered. See, e.g., Diamond v. Diehr, 450 U.S.
`175, 188-89, 209 USPQ 1, 9 (1981) (“In determining
`the eligibility of respondents’ claimed process for
`
`patent protection under § 101, their claims must be
`considered as a whole. It is inappropriate to dissect
`the claims into old and new elements and then to
`ignore the presence of the old elements in the
`analysis. This is particularly true in a process claim
`because a new combination of steps in a process may
`be patentable even though all the constituents of the
`combination were well known and in common use
`before the combination was made.”).
`
`II. CONDUCT A THOROUGH SEARCH OF THE
`PRIOR ART
`
`Prior to evaluating the claimed invention under 35
`U.S.C. 101, USPTO personnel are expected to
`conduct a thorough search of the prior art. Generally,
`a thorough search involves reviewing both U.S. and
`foreign patents and nonpatent literature. In many
`cases, the result of such a search will contribute to
`USPTO personnel’s understanding of the invention.
`Both claimed and unclaimed aspects of the invention
`described in the specification should be searched if
`there is a reasonable expectation that the unclaimed
`aspects may be later claimed. A search must take
`into account any structure or material described in
`the specification and
`its equivalents which
`correspond to the claimed means- (or step-) plus-
`function limitation, in accordance with 35 U.S.C.
`112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph
`and MPEP § 2181 through MPEP § 2186.
`
`III. DETERMINE WHETHER THE CLAIMED
`INVENTION COMPLIES WITH 35 U.S.C. 101
`
`A. Consider the Breadth of 35 U.S.C. 101 Under
`Controlling Law
`
`Section 101 of title 35, United States Code, provides:
`
`Whoever invents or discovers any new and
`useful process, machine, manufacture, or
`composition of matter, or any new and useful
`improvement thereof, may obtain a patent
`therefor, subject to the conditions and
`requirements of this title.
`
`35 U.S.C. 101 defines four categories of inventions
`that Congress deemed to be the appropriate subject
`matter of
`a patent: processes, machines,
`manufactures and compositions of matter. The latter
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`MANUAL OF PATENT EXAMINING PROCEDURE
`
`three categories define “things” or “products” while
`the first category defines “actions” (i.e., inventions
`that consist of a series of steps or acts to be
`performed). See 35 U.S.C. 100(b) (“The term
`‘process’ means process, art, or method, and includes
`a new use of a known process, machine,
`manufacture, composition of matter, or material.”).
`
`The subject matter which courts have found to be
`outside of, or exceptions to, the four statutory
`categories of invention is limited to abstract ideas,
`laws of nature and natural phenomena (i.e., the
`judicial exceptions). Alice Corp. Pty. Ltd. v. CLS
`Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2354, 110
`USPQ2d 1976, 1980 (2014) (citing Association for
`Molecular Pathology v. Myriad Genetics, Inc., 569
`U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972,
`1979 (2013)). See also Bilski v. Kappos, 561
`U.S.593, 601, 130 S. Ct. 3218, 3225, 95 USPQ2d
`1001, 1005-06 (2010) (citing
` Diamond v.
`Chakrabarty, 447 U.S. 303, 309, 206 USPQ 193,
`197 (1980)).
`
`The Supreme Court's concern that drives this
`"exclusionary principle" is pre-emption. Alice Corp.,
`134 S. Ct. at 2354, 110 USPQ2d at 1980 (citing
` Bilski, 561 U.S. at 611-612, 95 USPQ2d at 1010
`("upholding the patent 'would pre-empt use of this
`approach in all fields, and would effectively grant a
`monopoly over an abstract idea'"). The courts have
`held that a claim may not preempt abstract ideas,
`laws of nature, or natural phenomena, i.e., one may
`not patent every "substantial practical application"
`of an abstract idea, law of nature, or natural
`phenomenon. This is because such a patent would
`"in practical effect be a patent on the [abstract idea,
`law of nature or natural phenomenon] itself."
` Gottschalk v. Benson, 409 U.S. 63, 71, 72, 175
`USPQ 673, 676 (1972). The concern over
`preemption was expressed as early as 1852. See Le
`Roy v. Tatham, 55 U.S. 156, 175 (1852) (“A
`principle, in the abstract, is a fundamental truth; an
`original cause; a motive; these cannot be patented,
`as no one can claim in either of them an exclusive
`right.”).
`
`laws of nature, and natural
`ideas,
`Abstract
`phenomenon "are the basic tools of scientific and
`technological work." Mayo Collaborative Serv. v.
`Prometheus Labs., Inc., 566 U.S. _, 132 S. Ct. 1289,
`
`1293, 101 USPQ2d 1961, 1965 (2012) (citing
` Gottschalk v. Benson, 409 U.S. 63, 67, 97, 175
`USPQ 673, 675 (1972)). Thus, the courts have
`expressed concern that monopolizing these tools by
`granting patent rights may impede innovation rather
`than promote it. See Alice Corp., 134 S. Ct. at 2354,
`110 USPQ2d at 1980 (citing Mayo, 132 S. Ct. at
`1293, 101 USPQ2d at 1965). However, the courts
`have carefully construed this "exclusionary principle
`lest it swallow all of patent law" because "all
`inventions at some level embody, use, reflect, rest
`upon, or apply laws of nature, natural phenomenon,
`or abstract ideas." Alice, 134 S. Ct. at 2354, 110
`USPQ2d at 1980 (citing Mayo, 132 S. Ct. at 1293,
`101 USPQ2d at 1965). Therefore, an invention is
`not considered to be ineligible for patent simply
`because it involves a judicial exception. Alice, 134
`S. Ct. at 2354, 110 USPQ2d at 1980-81 (citing
` Diamond v. Diehr, 450 U.S. 174, 187 (1981)).
`
`The courts have held that an application of an
`abstract idea, law of nature or natural phenomenon
`"to a new and useful end" is eligible for patent
`protection. Alice, 134 S. Ct. at 2354, 110 USPQ2d
`at 1980 (citing Benson, 409 U.S. at 67, 175 USPQ
`at 675). However, to transform an abstract idea, law
`of nature or natural phenomenon
`into "a
`patent-eligible application", the claim must recite
`more than simply the judicial exception "while
`adding the words 'apply it.'" Mayo, 132 S. Ct. at
`1294, 101 USPQ2d at 1965. Further, patent
`eligibility under 35 U.S.C. section 101 must not
`depend simply on the draftsman's art. Alice, 134 S.
`Ct. at 2360, 110 USPQ2d at 1985 (citing Mayo 132
`S. Ct. at 1294, 101 USPQ2d at 1966).
`
`Determining whether an applicant is seeking to
`patent a judicial exception, namely an abstract idea,
`a law of nature or a natural phenomenon, or a
`patent-eligible application of the judicial exception
`has proven to be challenging. The Supreme Court
`in Mayo Collaborative Serv. v. Prometheus Labs.,
`Inc., 566 U.S. _, 132 S. Ct. 1289, 1301, 101 USPQ2d
`1961, 1966 (2013) laid out a framework for making
`this determination. See also Alice, 134 S. Ct. at
`2355, 110 USPQ2d at 1981. This framework, which
`is referred to as the Mayo test, is discussed in further
`detail in MPEP § 2106. The first part of the test is
`to determine whether the claims are directed to an
`abstract idea, a law of nature or a natural
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`phenomenon (i.e., a judicial exception). If the claims
`are directed to a judicial exception, the second part
`of the test is to determine when the claim recites
`additional elements that amount to significantly more
`than the judicial exception. The Supreme Court has
`described the second part of the test as the "search
`for an 'inventive concept'". Alice, 134 S. Ct. at 2355,
`110 USPQ2d at 1981 (citing Mayo 132 S. Ct. at
`1294, 101 USPQ2d at 1966).
`
`The Supreme Court in Bilski v. Kappos, 561 U.S.
`593, 130 S. Ct. 3218, 95 USPQ2d 1001 (2010), made
`clear that business methods are not "categorically
`outside of § 101’s scope," stating that "a business
`method is simply one kind of ‘method’ that is, at
`least in some circumstances, eligible for patenting
`under § 101." Thus, examiners are reminded that
`software and business methods are not excluded
`categories of subject matter. For example, software
`is not automatically an abstract idea. While some
`software may include an abstract idea (such as a step
`that employs a mathematical relationship), further
`analysis of the claim as a whole would be required
`to determine eligibility.
`
`In addition, examiners are reminded that 35 U.S.C.
`101 is not the sole tool for determining patentability;
`where a claim encompasses an abstract idea, law of
`nature, or natural phenomenon, 35 U.S.C. 112 , 35
`U.S.C. 102 , and 35 U.S.C. 103 will provide
`additional tools for ensuring that the claim meets the
`conditions for patentability. As the Supreme Court
`made clear in Bilski:
`
`The § 101 patent-eligibility inquiry is only a
`threshold test. Even if an invention qualifies as
`a process, machine, manufacture, or
`composition of matter, in order to receive the
`Patent Act’s protection the claimed invention
`must also satisfy ‘‘the conditions and
`requirements of this title.’’ § 101. Those
`requirements include that the invention be
`novel, see § 102, nonobvious, see § 103, and
`fully and particularly described, see § 112.
`
`Therefore, examiners should avoid focusing on
`issues of patent-eligibility under 35 U.S.C. 101 to
`the detriment of considering an application for
`compliance with the requirements of 35 U.S.C. 112,
`
`35 U.S.C. 102, and 35 U.S.C. 103, and should avoid
`treating an application solely on the basis of
`patent-eligibility under 35 U.S.C. 101 except in the
`most extreme cases.
`
`See MPEP § 2106 for determining whether a claim
`is directed to patent-eligible subject matter.
`
`See MPEP § 2107 for a detailed discussion of utility,
`which is a separate requirement from eligibility
`under 35 U.S.C. 101, and requires that inventions
`be useful or have a utility that is specific, substantial
`and credible.
`
`IV. EVALUATE APPLICATION FOR
`COMPLIANCE WITH 35 U.S.C. 112
`
`A. Determine Whether the Claimed Invention Complies
`with 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second
`Paragraph Requirements
`
`35 U.S.C. 112(b) and the second paragraph of
`pre-AIA 35 U.S.C. 112 contains two separate and
`distinct requirements: (A) that the claim(s) set forth
`the subject matter applicants regard as the invention,
`and (B) that the claim(s) particularly point out and
`distinctly claim the invention. An application will
`35 U.S.C.
`be deficient under the first requirement of
`112(b) or pre-AIA 35 U.S.C. 112, second paragraph
`when evidence including admissions, other than in
`the application as fil