Manual of PATENT
`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
`
`TCL 1048, Page 1
`
`          
`

`

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`
`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
`
`TCL 1048, Page 2
`
`     
`     
`     
`     
`     
`               
`

`

`Chapter 2100 Patentability
`
`
`Plant Genetics — What Constitutes
`
`2101
`-2102
`2103
`2104
`2105
`
`
`
`
`
`
`
`
`
`
`
`
`2106
`2106.01
`2107
`
`Patent Examination Process
`
`[Reserved]
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Patentable Subject Matter
`Patentable Subject Matter — Living
`Subject Matter
`Patent Subject Matter Eligibility
`[Reserved]
`Guidelines for Examination of
`
`Applications for Compliance with the
`
`2121.03
`
`2121.04
`
`2122
`
`2123
`
`2124
`
`Discussion of Utility in the Prior Art
`Rejection Over Prior Art’s Broad
`Disclosure Instead of Preferred
`Embodiments
`
`Enabling Prior Art
`Apparatus and Articles — What
`Constitutes Enabling Prior Art
`
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`Reference Date Must Precede the Filing
`Date
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`Utility Requirement
`General Principles Governing Utility
`Rejections
`Procedural Considerations Related to
`
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`Rejections for Lack of Utility
`Special Considerations for Asserted
`Therapeutic or Pharmacological
`Utilities
`
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`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
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`Domestic and Foreign Patent
`Applications as Prior Art
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`Scope of Reference’s Disclosure
`Which Can Be Used to Reject Claims
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`Requirements of Rejection Based on
`Inherency; Burden of Proof
`Composition, Product, and Apparatus
`Claims
`Process Claims
`
`2129
`2130
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`Date Publication Is Available as a
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`Admissions as Prior Art
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`Close Structural Similarity Between
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