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2137 35 U.S.CA02(f) 2137.01 Inventorship 2137.02 Applicabilityof35 U:S,C. 103{c) 2138 35 U.s.C. 102(g) 2138.01 Interference Practice 2138.02 "The Invention Was Made in This Country" 2138.03 "By Another Who Has Not Abandoned, Suppressed, or Concealed It" 2138.04 "Conception" 2138.05 "Reduction to Practice" 2138.06 "Reasonable Diligence" 2141 35 U.s.C. 103; The Graham Factual Inquiries 2141.01 Scope and Contentofthe Prior Art 2141.01(a) Analogous and Nonanalogous Art 2141.02 Differences Between Prior Art and Claimed Invention 2141.03 Level of Ordinary Skill in the Art 2142 Legal Concept of PrimaFacle Obviousness 2143 Basic Requirements of a Prima Facie Case of Obviousness 2143.01 Suggestion or Motivation to Modify the 2143.02 2143.03 2144.04 2144.05 2144.06 2144.07 2144.08 2144.09 2146 2161 MANUAL OF PATENTEXAMINING PROCEDURE References ,ReasonableExpectation ofSuccess Is Required All Claim Limitations Mnst Be Taught or Suggested 2144 Sources of Rationale Supporting a Rejection Under 35 us.c, 103 2144.01 Implicit Disclosure 2144.02 Reliance on Scientific Theory 2144.03 Reliance on Common Knowledge in the Art or "WellKnown" Prior Art Legal Precedent as Source of Supporting Rationale Obviousness of Ranges Art Recognized Equivalence for the Same Purpose Art Recognized Snitability for an Intended Purpose Obviousness of Species When Prior Art Teaches Genus Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers) 2145 Consideration of Applicant's Rebnttal Argmnents 35 U.S.C.I03(c) ,ThreeSeparateReqnirements for Specification Under 35 U.S.C. 112, First Paragraph 2162 Policy Underlying 35 U.S.C. 112, First Paragraph 2163 Gnidelines for the Examination of Patent Applications Under the 35 U.s.C. 112, para. 1, ''Written Description" Requirement August2001 2100-2 2163.01 2163.02 2163.03 2163.04 2163.05 2163.06 2163.07 Support for the Claimed Subject Matter in Disclosure Standard for Determining Compliance With the.Written Description Requirement Typical Circumstances Where Adeqnate Written Description Issne Arises Burden on the Examiner With Regard to the .Written Description Requirement Changes to the Scope ofClaims Relationship of Written Description Requirement to New Matter Amendments to Application Which Are Supported in the Original Description 2163.07(a) Inherent Function, Theory, or Advantage 2163.07(b) Incorporation by Reference 2164 The Enablement Requirement 2164.01 Test ofEnab1ement 2164.01(a) Undue Experimentation Factors 2164.01(b) How to Make the Claimed Invention 2164.01(c) How to Use the Claimed Invention 2164.02 Working Example 2164.03 Relationship of Predictability of the Art and the Enab1ement Requirement 2164.04 Burden on the Examiner Under the Enab1ement Requirement 2164.05 Determination ofEnablement Based on Evidence as a Whole 2164.05(a) Specification Must Be Enabling as of the Filing Date 2164.05(b) Specification Must Be Enabling to Persons Skilled in the Art 2164.06 Quantity ofExperimentation 2164.06(a) Examples of Euab1emeut Issues-Missing Infomiation 2164.06(b) Examples ofEnab1einent Issues - Chemical Cases 2164.07 Relationship of Enablement Reqnirement to Utility Requirement of 35 U.S.C. 101 2164.08 Enablement Commensurate in Scope With the Claims 2164.08(a) Single Means Claim 2164.08(b) Inoperative Snbject Matter 2164.08(c) Critical Feature Not Claimed 2165 The Best Mode Reqnirement 2165;01 Considerations Relevantto Best Mode 2165.02 BestModeRequirementCompared to Euab1ement Requirement 2165.03 Requirements for Rejection for Lackof Best Mode 2165.04 Examples .of Evidence of Concealment 2171 Two Separate Reqnirements for Claims Under 35 U.S.C. 112, Second Paragraph
2172 Subject Matter Which Applicants Regard as Their Invention 2172.01 Unclaimed Essential Matter 2173 Claims Mnst Particularly Point Out and Distinctly Claim the Invention 2173.01 Claim Terminology 2173.02 Clarity and Precision 2173.03 Inconsistency Between Claim and 2173.04 2173.05 2173.05(a) 21n05(b) 2173.05(c) 2173.05(d) 2173.05(q) 2173.05(r) 2173.05(s) 2173.05(t) 2173.05(u) 2173.05(v) 2173.06 2183 2184 Specification Disclosure or Prior Art Breadth Is Not Indefiniteness Specific Topics Related to Issnes Under 35 U.S.c. 112, Second Paragraph New Terminology Relative Terminology Nnmerical Ranges and Amonnts Limitations Exemplary Claim Language ("for example," "such as") 2173.05(e) Lack of Antecedent Basis 2173.05(t) Reference to Limitations in Another Claim 2173.05(g) Functional Limitations 2173.05(h) Alternative Limitations 2173.05(i) Negative Limitations 2173.050) Old Combination 2173.05(k) Aggregation 2173.05(m) Prolix 2173.05(n) Multiplicity 2173.05(0) Double Inclusion 2173.05(p) Claim Directed to Product-By-Process or Product and Process "Use" Claims Omuibus Claim Reference to Figures or Tables Chemical Formula Trademarks or Trade Names in a Claim Mere Function ofMachine Prior Art Rejection of Claim Rejected as Indefinite 2174 Relationship Between the Requirements ofthe First and Second Paragraphs of35 US.c. 112 2181 Identifying a 35 U.s.C. 112, Sixth Paragraph Limitation 2182 Scope ofthe Search and Identification ofthe Prior Art Making a Prima Facie Case of Equivalence Determiuing Whether an Applicant Has Met the Burden ofProving Nonequivalence After a Prima Facie Case Is Made 2185 Related Issues Under 35 U.s.C. 112, First or Second Paragraphs 2186 Relationship to the Doctrine of Equivalents PATENTABILITY 2105 2105 Patentable Subject Matter Living Subject Matter The decision of the Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), held that microorganisms produced by genetic engineering are not excluded from patent protection by 35 U.S.C. 101. It is clear from the Supreme Court decision and opinion that the question of whether or not an invention embraces living matter is irrelevant to the issue of patentability. The test set down by the Court for patentable subject matter in this area is whether the living matter is the result of human intervention. In view of this decision, the Office has issued these guidelines as to how 35 U.S.c. 101 will be interpreted. The Supreme Court made the following points in the Chakrabarty opinion: 1. "Guided by these canons of construction; this Court has read the term 'manufacture' in § 101 in accordance with its dictionary defmition to mean 'the production of articles for use from raw materials prepared by giving to these materials new forms,qualities, properties, or combinations whether by hand labor or by machinery.'" 2. "In choosing such expansive terms as 'manufacture' and 'composition of matter,' modified by the comprehensive 'any.t Congress plainly contemplated that the patent laws would be given wide scope." -3. "The Act embodied Jefferson's philosophy that 'ingenuity should receive a liberal encouragement.' 5 Writings of Thomas Jefferson, at 75-76. See Graham v. John Deere Co.; 383 U.S. 1, 7-10 (1966). Subsequent patent statutes in 1836, 1870, and 1874 employed this same broad language. In 1952, when the patent laws were recodified, Congress replaced the word 'art' with 'process,' but otherwise left Jefferson's language intact. The Committee Reports accompanying the 1952 act inform us that Congress intended statutory subject matter to 'include any thing under the sun that is made by man.' S. Rep. No. 1979, 82dCong., 2d Sess.,5 (1952)." 4. "This -is not to suggest that § 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable." 5. "Thus, a new mineral discovered in the earth or a new plant found in-the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law 2100-3 August 2001
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