[3510-16-P]
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`DEPARTMENT OF COMMERCE
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`United States Patent and Trademark Office
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`37 CFR Part 1
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`[Docket No. PTO-P-2014-0058]
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`2014 Interim Guidance on Patent Subject Matter Eligibility
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`AGENCY: United States Patent and Trademark Office, Commerce.
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`ACTION: Examination guidance; request for comments.
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`SUMMARY: The United States Patent and Trademark Office (USPTO or Office) has
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`prepared interim guidance (2014 Interim Guidance on Patent Subject Matter Eligibility,
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`called “Interim Eligibility Guidance”) for use by USPTO personnel in determining
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`subject matter eligibility under 35 U.S.C. 101 in view of recent decisions by the U. S.
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`Supreme Court (Supreme Court). This Interim Eligibility Guidance supplements the June
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`25, 2014, Preliminary Examination Instructions in view of the Supreme Court decision in
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`Alice Corp. (June 2014 Preliminary Instructions) and supersedes the March 4, 2014,
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`Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws
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`Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products (March 2014
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`Procedure) issued in view of the Supreme Court decisions in Myriad and Mayo. The
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`SAMSUNG-1059
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`USPTO is seeking public comment on this Interim Eligibility Guidance along with
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`additional suggestions on claim examples for explanatory example sets.
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`DATES: EFFECTIVE DATE: This Interim Eligibility Guidance is effective on [Insert
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`date of publication in the FEDERAL REGISTER]. This Interim Eligibility Guidance
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`applies to all applications filed before, on or after [Insert date of publication in the
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`FEDERAL REGISTER].
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`COMMENT DEADLINE DATE: To be ensured of consideration, written comments
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`must be received on or before [Insert date 90 days after the date of publication in the
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`FEDERAL REGISTER].
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`ADDRESSES: Comments on this Interim Eligibility Guidance must be sent by
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`electronic mail message over the Internet addressed to:
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`2014_interim_guidance@uspto.gov. Electronic comments submitted in plain text are
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`preferred, but also may be submitted in ADOBE® portable document format or
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`MICROSOFT WORD® format. The comments will be available for viewing via the
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`Office’s Internet Web site (http://www.uspto.gov). Because comments will be made
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`available for public inspection, information that the submitter does not desire to make
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`public, such as an address or phone number, should not be included in the comments.
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`FOR FURTHER INFORMATION CONTACT: Raul Tamayo, Senior Legal Advisor,
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`Office of Patent Legal Administration, by telephone at 571-272-7728, or Michael Cygan,
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`Senior Legal Advisor, Office of Patent Legal Administration, by telephone at 571-272-
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`7700.
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`SUPPLEMENTARY INFORMATION: Section 2106 of the Manual of Patent
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`Examining Procedure (MPEP) sets forth guidance for use by USPTO personnel in
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`determining subject matter eligibility under 35 U.S.C. 101. See MPEP 2106 (9th ed.
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`2014). The USPTO has prepared this Interim Eligibility Guidance for use by USPTO
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`personnel in determining subject matter eligibility under 35 U.S.C. 101 in view of recent
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`decisions by the Supreme Court. The following Interim Eligibility Guidance on patent
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`subject matter eligibility under 35 U.S.C. 101 supplements the June 25, 2014,
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`Preliminary Examination Instructions in view of the Supreme Court Decision in Alice
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`Corporation Pty. Ltd. v. CLS Bank International, et al.1 (June 2014 Preliminary
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`Instructions) and supersedes the March 4, 2014, Procedure For Subject Matter Eligibility
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`Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural
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`Phenomena, And/Or Natural Products (March 2014 Procedure)2 issued in view of the
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`Supreme Court decisions in Association for Molecular Pathology v. Myriad Genetics,
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`Inc.3 and Mayo Collaborative Services v. Prometheus Laboratories Inc.4 Implementation
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`1 Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. __, 134 S. Ct. 2347 (2014).
`2 This analysis differs from the March 2014 Procedure in certain respects. Note, for example, the test for
`determining whether a claim is directed to a “product of nature” exception is separated from the analysis of
`whether the claim includes significantly more than the exception. Also, the application of the overall
`analysis is based on claims directed to judicial exceptions (defined as claims reciting the exception, i.e., set
`forth or described), rather than claims merely “involving” an exception. For instance, process claims that
`merely use a nature-based product are not necessarily subject to an analysis for markedly different
`characteristics. Additionally, the markedly different analysis focuses on characteristics that can include a
`product’s structure, function, and/or other properties as compared to its naturally occurring counterpart in
`its natural state.
`3 Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107 (2013).
`4 Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. __, 132 S. Ct. 1289 (2012).
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`of examination guidance on eligibility will be an iterative process continuing with
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`periodic supplements based on developments in patent subject matter eligibility
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`jurisprudence5 and public feedback.
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`The USPTO is seeking written comments on this guidance, as well as additional
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`suggestions for claim examples to use for examiner training. Further, the USPTO plans
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`to hold a public forum in mid-January 2015 in order to discuss the guidance and next
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`steps and to receive additional oral input. When the date and location are finalized,
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`notice of the forum will be provided on the Office’s Internet Web site
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`(http://www.uspto.gov).
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`This Interim Eligibility Guidance does not constitute substantive rulemaking and does not
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`have the force and effect of law. This Interim Eligibility Guidance sets out the Office’s
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`interpretation of the subject matter eligibility requirements of 35 U.S.C. 101 in view of
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`recent decisions by the Supreme Court and the U.S. Court of Appeals for the Federal
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`Circuit (Federal Circuit), and advises the public and Office personnel on how these court
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`decisions impact the provisions of MPEP 2105, 2106 and 2106.01. This Interim
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`Eligibility Guidance has been developed as a matter of internal Office management and is
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`not intended to create any right or benefit, substantive or procedural, enforceable by any
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`party against the Office. Rejections will continue to be based upon the substantive law,
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`5 The Court of Appeals for the Federal Circuit has a number of pending appeals that could result in further
`refinements to the eligibility guidance, including for example, University of Utah Research Foundation v.
`Ambry Genetics Corp. (In re BRCA1- & BRCA2- Based Hereditary Cancer Test Patent Litigation), No.
`14-1361 (Fed. Cir. filed Mar. 18, 2014), and Ariosa Diagnostics, Inc. v. Sequenom, Inc., No. 14-1139 (Fed.
`Cir. filed Dec. 4, 2013).
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`and it is these rejections that are appealable. Failure of Office personnel to follow this
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`Interim Eligibility Guidance is not, in itself, a proper basis for either an appeal or a
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`petition.
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`This Interim Eligibility Guidance offers a comprehensive view of subject matter
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`eligibility in line with Alice Corp, Myriad, Mayo, and the related body of case law, and is
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`responsive to the public comments received pertaining to the March 2014 Procedure and
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`the June 2014 Preliminary Instructions (see the Notice of Forum on the Guidance for
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`Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature,
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`Natural Phenomena, and Natural Products, 79 FR 21736 (Apr. 17, 2014) and the Request
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`for Comments and Extension of Comment Period on Examination Instruction and
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`Guidance Pertaining to Patent-Eligible Subject Matter, 79 FR 36786 (June 30, 2014)). In
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`conjunction with this Interim Eligibility Guidance, a set of explanatory examples relating
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`to nature-based products is being released to replace the prior examples issued with the
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`March 2014 Procedure and the related training. The explanatory examples relating to
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`nature-based products address themes raised in the public comments and adopt many
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`suggestions from the comments. Additional explanatory example sets relating to claims
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`that do and do not amount to significantly more than a judicial exception are being
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`developed and will be issued at a future date, taking into account suggestions already
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`received from the public comments, future public comments, and any further judicial
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`developments.
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`The June 2014 Preliminary Instructions superseded MPEP sections 2106(II)(A) and
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`2106(II)(B). MPEP 2105 is also superseded by this Interim Eligibility Guidance to the
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`extent that it suggests that “mere human intervention” necessarily results in eligible
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`subject matter. MPEP 2106.01 is additionally now superseded with this interim
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`guidance. Examiners should continue to follow the MPEP for all other examination
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`instructions. The following sections pertain to examining for patent subject matter
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`eligibility with details on determining what applicant invented and making a rejection
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`under 35 U.S.C. 101 and should be reviewed closely as they are not duplicated in this
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`Interim Eligibility Guidance:
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`• MPEP 2103: Patent Examination Process
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`(cid:131) 2103(I): Determine What Applicant Has Invented and Is Seeking to Patent
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`(cid:131) 2103(II): Conduct a Thorough Search of the Prior Art
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`(cid:131) 2103(III): Determine Whether the Claimed Invention Complies with 35 U.S.C
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`101
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`(cid:131) 2103(IV): Evaluate Application for Compliance with 35 U.S.C. 112
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`(cid:131) 2103(V): Determine Whether the Claimed Invention Complies with 35 U.S.C.
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`102 and 103
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`(cid:131) 2103(VI): Clearly Communicate Findings, Conclusions, and Their Bases
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`• MPEP 2104: Patentable Subject Matter
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`• MPEP 2105: Patentable Subject Matter – Living Subject Matter6
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`6 To the extent that MPEP 2105 suggests that mere “human intervention” necessarily results in eligible
`subject matter, it is superseded by this Interim Eligibility Guidance. As explained herein, if human
`intervention has failed to confer markedly different characteristics on a product derived from nature, that
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`• MPEP 2106: Patent Subject Matter Eligibility
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`(cid:131) 2106(I): The Four Categories of Statutory Subject Matter
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`(cid:131) 2106(II): Judicial Exceptions to the Four Categories (not subsections (II)(A) and
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`(II)(B))
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`(cid:131) 2106(III): Establish on the Record a Prima Facie Case
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`The current version of the MPEP (9th ed., March 2014) incorporates patent subject matter
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`eligibility guidance issued as of November 2013.
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`
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`product is a judicial exception (a product of nature exception). See generally Myriad; In re Roslin Inst.
`(Edinburgh), 750 F.3d. 1333 (Fed. Cir. 2014).
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`This Interim Eligibility Guidance is divided into the following sections:
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`Flowchart: Eligibility Test for Products and Processes;
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`Part I: Two-part Analysis for Judicial Exceptions;
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`Part II: Complete Examination;
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`Part III: Sample Analysis; and
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`Part IV: Summaries of Court Decisions Relating to Laws of Nature, Natural Phenomena,
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`and Abstract Ideas.
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`The following flowchart illustrates the subject matter eligibility analysis for products and
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`processes to be used during examination for evaluating whether a claim is drawn to
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`patent-eligible subject matter. It is recognized that under the controlling legal precedent
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`there may be variations in the precise contours of the analysis for subject matter
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`eligibility that will still achieve the same end result. The analysis set forth herein
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`promotes examination efficiency and consistency across all technologies.
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`SUBJECT MA'I'I'ER ELIGIBILITY TEST FOR
`PRODUCTS AND PROCESSES
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`PRIOR TO EI/ALUA77NG' A CLAIM FOR PATENTABILITY, ESTABLISH THE
`BROADEST R5480M43LE INTERPRETATION OF THE CLAIM
`A/WIL YZE THE CLAIM A5 A IM-IOLE VW-IEN El/ALUA77NG FOR PATENTABILITY.
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`
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` IS THE CLAIM TO
`A PROCESS, MACHINE,
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`MANUFACTURE OR
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`COMPOSITION OF
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`MA'I'I'ER?
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`
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`( Step 2A)
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`[PART 7 Mayo test]
`IS THE CLAIM DIRECTED
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`
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`TO A LAW OF NATURE, A
`NATURAL PHENOMENON, OR AN
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`ABSTRACT IDEA
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`( JUDICIALLY RECOGNIZED
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`EXCEPTIONS) ?
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`
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`
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`( Step 2B)
`[PART 2 Mayo test]
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`DOES THE CLAIM RECITE
`YES
`ADDITIONAL ELEMENTS THAT
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`AMOUNT TO SIGNIFICANTLY
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`MORE THAN THE JUDICIAL
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`EXCEPTION?
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`CLAIM QUALIFIES
`AS ELIGIBLE SUBJECT
`MA'I'I'ER UNDER
`35 USC 101
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` CLAIM IS NOT
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`ELIGIBLE SUBJECT
`MA'I'I'ER
`UNDER 35 USC 101
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`IN ACCORDANCE WITH COMPACT PROSECUTION, ALONG WITH DETERMINING ELIGIBILITY, ALL
`CLAIMS ARE TO BE FULLY EXAMINED UNDER EACH OF THE OTHER PATENTABILITY
`REQUIREMENTS: 35 USC §§ 102, 103,
`112, and 101 (UTILITY,
`INVENTORSHIP, DOUBLE
`PATENTING) AND NON- STATUTORY DOUBLE PATENTING.
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`
`to the same steps.
`are subject
`oAII claims (product and process) with a judicial exception (any type)
`oClaims including a nature— based product are analyzed in Step 2A to identify whether the claim is directed
`to (recites)
`a “product of nature” exception. This analysis compares the nature— based product
`in the claim
`to its naturally occurring counterpart
`to identify markedly different characteristics based on structure,
`function,
`and/ or properties. The analysis proceeds to Step 2B only when the claim is directed to an exception (when
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`
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` Notable changes from prior guidance:no markedly different characteristics are shown) .
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`2014 Interim Eligibility Guidance: In accordance with the existing two-step analysis
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`for patent subject matter eligibility under 35 U.S.C. 101 explained in MPEP 2106, the
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`claimed invention (Step 1) “must be directed to one of the four statutory categories” and
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`(Step 2) “must not be wholly directed to subject matter encompassing a judicially
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`recognized exception.” Referring to the attached flowchart titled Subject Matter
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`Eligibility Test for Products and Processes, Step 1 is represented in diamond (1), which is
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`explained in MPEP 2106(I). Step 2 is represented in diamonds (2A) and (2B) and is the
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`subject of this Interim Eligibility Guidance. Step 2 is the two-part analysis from Alice
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`Corp.7 (also called the Mayo test) for claims directed to laws of nature, natural
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`phenomena, and abstract ideas (the judicially recognized exceptions).
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`I.
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`Two–part Analysis for Judicial Exceptions
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`A. Flowchart Step 2A (Part 1 Mayo Test) - Determine whether the claim is
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`directed to a law of nature, a natural phenomenon, or an abstract idea (judicial
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`exceptions).
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`After determining what applicant has invented by reviewing the entire application
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`disclosure and construing the claims in accordance with their broadest reasonable
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`interpretation (MPEP 2103), determine whether the claim as a whole is directed to a
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`judicial exception. A claim to a process, machine, manufacture or composition of matter
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`(Step 1: YES) that is not directed to any judicial exceptions (Step 2A: NO) is eligible
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`and needs no further eligibility analysis. A claim that is directed to at least one exception
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`7 Alice Corp., 134 S. Ct. at 2355.
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`(Step 2A: YES) requires further analysis to determine whether the claim recites a patent-
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`eligible application of the exception (Step 2B).
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`1. Determine What the Claim Is “Directed to”
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`A claim is directed to a judicial exception when a law of nature, a natural phenomenon,
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`or an abstract idea is recited (i.e., set forth or described) in the claim. Such a claim
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`requires closer scrutiny for eligibility because of the risk that it will “tie up”8 the excepted
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`subject matter and pre-empt others from using the law of nature, natural phenomenon, or
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`abstract idea. Courts tread carefully in scrutinizing such claims because at some level all
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`inventions embody, use, reflect, rest upon, or apply a law of nature, natural phenomenon,
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`or abstract idea.9 To properly interpret the claim, it is important to understand what the
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`applicant has invented and is seeking to patent.
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`
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`For claims that may recite a judicial exception, but are directed to inventions that clearly
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`do not seek to tie up the judicial exception, see Section I.B.3. regarding a streamlined
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`eligibility analysis.
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`8 Mayo, 132 S. Ct. at 1301 (“[E]ven though rewarding with patents those who discover new laws of nature
`and the like might well encourage their discovery, those laws and principles, considered generally, are ‘the
`basic tools of scientific and technological work.’ And so there is a danger that the grant of patents that tie
`up their use will inhibit future innovation premised upon them, a danger that becomes acute when a
`patented process amounts to no more than an instruction to ‘apply the natural law,’ or otherwise forecloses
`more future invention than the underlying discovery could reasonably justify” (quoting Gottschalk v.
`Benson, 409 U.S. 63, 67 (1972)).
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`2. Identify the Judicial Exception Recited in the Claim
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`MPEP 2106(II) provides a detailed explanation of the judicial exceptions and their legal
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`bases. It should be noted that there are no bright lines between the types of exceptions
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`because many of these concepts can fall under several exceptions. For example,
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`mathematical formulas are considered to be an exception as they express a scientific
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`truth, but have been labelled by the courts as both abstract ideas and laws of nature.
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`Likewise, “products of nature” are considered to be an exception because they tie up the
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`use of naturally occurring things, but have been labelled as both laws of nature and
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`natural phenomena. Thus, it is sufficient for this analysis to identify that the claimed
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`concept aligns with at least one judicial exception.
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`
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`Laws of nature and natural phenomena, as identified by the courts, include naturally
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`occurring principles/substances and substances that do not have markedly different
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`characteristics compared to what occurs in nature. See Section I.A.3. for a discussion of
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`the markedly different characteristics analysis used to determine whether a claim that
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`includes a nature-based product limitation recites an exception. The types of concepts
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`courts have found to be laws of nature and natural phenomena are shown by these cases,
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`which are intended to be illustrative and not limiting:
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`• an isolated DNA (Myriad: see Section III, Example 2);
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`9 An invention is not rendered ineligible for patent simply because it involves an abstract concept.
`Applications of such concepts “to a new and useful end,” remain eligible for patent protection. Alice Corp.,
`134 S.Ct. at 2354 (quoting Benson, 409 U.S. at 67).
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`12
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`• a correlation that is the consequence of how a certain compound is metabolized
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`by the body (Mayo: see Section III, Example 5);
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`• electromagnetism to transmit signals (Morse:10 see Section IV.A.1.); and
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`•
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`the chemical principle underlying the union between fatty elements and water
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`(Tilghman:11 see Section IV.A.2.).
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`
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`Abstract ideas have been identified by the courts by way of example, including
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`fundamental economic practices, certain methods of organizing human activities, an idea
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`‘of itself,’ and mathematical relationships/formulas.12 The types of concepts courts have
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`found to be abstract ideas are shown by these cases, which are intended to be illustrative
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`and not limiting:
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`• mitigating settlement risk (Alice: see Section III, Example 6);
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`• hedging (Bilski:13 see Section IV.A.5.);
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`• creating a contractual relationship (buySAFE:14 see Section IV.C.3.);
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`• using advertising as an exchange or currency (Ultramercial:15 see Section
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`IV.C.4.);
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`10 O’Reilly v. Morse, 56 U.S. 62 (1853).
`11 Tilghman v. Proctor, 102 U.S. 707 (1881).
`12 Alice Corp., 134 S. Ct. at 2355-56.
`13 Bilski v. Kappos, 561 U.S. 593 (2010).
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`13
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`• processing information through a clearinghouse (Dealertrack:16 see Section
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`IV.B.3.);
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`• comparing new and stored information and using rules to identify options
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`(SmartGene:17 see Section IV.B.4.);
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`• using categories to organize, store and transmit information (Cyberfone:18 see
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`Section IV.B.5.);
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`• organizing information through mathematical correlations (Digitech:19 see Section
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`IV.C.1.);
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`• managing a game of bingo (Planet Bingo:20 see Section IV.C.2.);
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`•
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`the Arrhenius equation for calculating the cure time of rubber (Diehr:21 see
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`Section III, Example 3);
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`• a formula for updating alarm limits (Flook:22 see Section III, Example 4);
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`• a mathematical formula relating to standing wave phenomena (Mackay Radio:23
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`see Section IV.A.3.); and
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`14 buySAFE, Inc. v. Google, Inc., ___ F.3d ___, 112 USPQ2d 1093 (Fed. Cir. 2014).
`15 Ultramercial, LLC v. Hulu, LLC and WildTangent, ___ F.3d ___, 112 USPQ2d 1750 (Fed. Cir. 2014).
`16 Dealertrack Inc. v. Huber, 674 F.3d 1315 (Fed. Cir. 2012).
`17 SmartGene, Inc. v. Advanced Biological Labs., SA, 555 Fed. Appx. 950 (Fed. Cir. 2014)
`(nonprecedential).
`18 Cyberfone Sys. v. CNN Interactive Grp., 558 Fed. Appx. 988 (Fed. Cir. 2014) (nonprecedential).
`19 Digitech Image Tech., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014).
`20 Planet Bingo, LLC v. VKGS LLC, ___ Fed. Appx.___ (Fed. Cir. 2014) (nonprecedential).
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`• a mathematical procedure for converting one form of numerical representation to
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`another (Benson:24 see Section IV.A.4.)
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`
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`3. Nature-based Products
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`a. Determine Whether The Markedly Different Characteristics Analysis Is
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`Needed To Evaluate a Nature-Based Product Limitation Recited in a Claim
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`Nature-based products, as used herein, include both eligible and ineligible products and
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`merely refer to the types of products subject to the markedly different characteristics
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`analysis used to identify “product of nature” exceptions. Courts have held that naturally
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`occurring products and some man-made products that are essentially no different from a
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`naturally occurring product are “products of nature”25 that fall under the laws of nature or
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`natural phenomena exception. To determine whether a claim that includes a nature-based
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`product limitation recites a “product of nature” exception, use the markedly different
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`characteristics analysis to evaluate the nature-based product limitation (discussed in
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`section I.A.3.b). A claim that recites a nature-based product limitation that does not
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`exhibit markedly different characteristics from its naturally occurring counterpart in its
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`natural state is directed to a “product of nature” exception (Step 2A: YES).
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`
`
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`21 Diamond v. Diehr, 450 U.S. 175 (1981).
`22 Parker v. Flook, 437 U.S. 584 (1978).
`23 Mackay Radio & Tel. Co. v. Radio Corp. of Am., 306 U.S. 86 (1939).
`24 Benson, 409 U.S. at 63.
`25 Myriad, 133 S. Ct. at 2111.
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`Care should be taken not to overly extend the markedly different characteristics analysis
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`to products that when viewed as a whole are not nature-based. For claims that recite a
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`nature-based product limitation (which may or may not be a “product of nature”
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`exception) but are directed to inventions that clearly do not seek to tie up any judicial
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`exception, see Section I.B.3. regarding a streamlined eligibility analysis. In such cases, it
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`would not be necessary to conduct a markedly different characteristics analysis.
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` nature-based product can be claimed by itself (e.g., “a Lactobacillus bacterium”) or as
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` A
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`one or more limitations of a claim (e.g., “a probiotic composition comprising a mixture of
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`Lactobacillus and milk in a container”). The markedly different characteristics analysis
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`should be applied only to the nature-based product limitations in the claim to determine
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`whether the nature-based products are “product of nature” exceptions. When the nature-
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`based product is produced by combining multiple components, the markedly different
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`characteristics analysis should be applied to the resultant nature-based combination,
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`rather than its component parts. In the example above, the mixture of Lactobacillus and
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`milk should be analyzed for markedly different characteristics, rather than the
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`Lactobacillus separately and the milk separately. The container would not be subject to
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`the markedly different characteristics analysis as it is not a nature-based product, but
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`would be evaluated in Step 2B if it is determined that the mixture of Lactobacillus and
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`milk does not have markedly different characteristics from any naturally occurring
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`counterpart and thus is a “product of nature” exception.
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`For a product-by-process claim, the analysis turns on whether the nature-based product in
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`the claim has markedly different characteristics from its naturally occurring counterpart.
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`(See MPEP 2113 for product-by-process claims.)
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` process claim is not subject to the markedly different analysis for nature-based
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` A
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`products used in the process, except in the limited situation where a process claim is
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`drafted in such a way26 that there is no difference in substance from a product claim (e.g.,
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`“a method of providing an apple.”).
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`
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`b. Markedly Different Characteristics Analysis: Structure, Function and/or
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`Other Properties27
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`The markedly different characteristics analysis compares the nature-based product
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`limitation to its naturally occurring counterpart in its natural state. When there is no
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`naturally occurring counterpart to the nature-based product, the comparison should be
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`made to the closest naturally occurring counterpart. In the case of a nature-based
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`combination, the closest counterpart may be the individual nature-based components that
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`form the combination, i.e., the characteristics of the claimed nature-based combination
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`are compared to the characteristics of the components in their natural state.
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`26 Alice Corp., 134 S. Ct. at 2360.
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`17
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`Markedly different characteristics can be expressed as the product’s structure, function,
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`and/or other properties,28 and will be evaluated based on what is recited in the claim on a
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`case-by-case basis. As seen by the examples that are being released in conjunction with
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`this Interim Eligibility Guidance, even a small change can result in markedly different
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`characteristics from the product’s naturally occurring counterpart. In accordance with
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`this analysis, a product that is purified or isolated, for example, will be eligible when
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`there is a resultant change in characteristics sufficient to show a marked difference from
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`the product’s naturally occurring counterpart. If the claim recites a nature-based product
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`limitation that does not exhibit markedly different characteristics, the claim is directed to
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`a “product of nature” exception (a law of nature or naturally occurring phenomenon), and
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`the claim will require further analysis to determine eligibility based on whether additional
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`elements add significantly more to the exception.
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`Non-limiting examples of the types of characteristics considered by the courts when
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`determining whether there is a marked difference include:
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`27 This revised analysis represents a change from prior guidance, because now changes in functional
`characteristics and other non-structural properties can evidence markedly different characteristics, whereas
`in the March 2014 Procedure only structural changes were sufficient to show a marked difference.
`28 To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an
`inherent or innate characteristic of the naturally occurring counterpart. Funk Bros. Seed Co. v. Kalo
`Inoculant Co., 333 U.S. 127, 130 (1948) (“[The inventor did] not create a state of inhibition or of non-
`inhibition in the bacteria. Their qualities are the work of nature. Those qualities are of course not
`patentable.”); In re Marden, 47 F.2d 958 (CCPA 1931) (eligibility of a claim to ductile vanadium held
`ineligible, because the “ductility or malleability of vanadium is . . . one of its inherent characteristics and
`not a characteristic given to it by virtue of a new combination with other materials or which characteristic is
`brought about by some chemical reaction or agency which changes its inherent characteristics”). Further, a
`difference in a characteristic that came about or was produced independently of any effort or influence by
`applicant cannot show a marked difference. Roslin, 750 F.3d at 1338 (Because “any phenotypic differences
`came about or were produced ‘quite independently of any effort of the patentee’” and were “uninfluenced
`by Roslin’s efforts”, they “do not confer eligibility on their claimed subject matter” (quoting Funk Bros.)).
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`18
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`• Biological or pharmacological functions or activities;29
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`• Chemical and physical properties;30
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`• Phenotype, including functional and structural characteristics;31 and
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`• Structure and form, whether chemical, genetic or physical.32
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`If the claim includes a nature-based product that has markedly different characteristics,
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`the claim does not recite a “product of nature” exception and is eligible (Step 2A: NO)
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`unless the claim recites another exception (such as a law of nature or abstract idea, or a
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`different natural phenomenon). If the claim includes a product having no markedly
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`different characteristics from the product’s naturally occurring counterpart in its natural
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`state, the claim is directed to an exception (Step 2A: YES), and the eligibility analysis
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`must proceed to Step 2B to determine if any additional elements in the claim add
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`significantly more to the exception. For claims that are to a single nature-based product,
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`once a markedly different characteristic in that product is shown, no further analysis
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`would be necessary for eligibility because no “product of nature” exception is recited
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`(i.e., Step 2B is not necessary because the answer to Step 2A is NO). This is a change
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`29 See, e.g., Funk Bros., 333 U.S. at 130-31 (properties and functions of bacteria such as a state of
`inhibition or non-inhibition and the ability to infect leguminous plants); Diamond v. Chakrabarty, 447 U.S.
`303, 310 (1980) (genetically modified bacterium’s ability to degrade hydrocarbons); In re King, 107 F.2d
`618 (CCPA 1939) (the ability of vitamin C to prevent and treat scurvy); Myriad, 133 S. Ct. at 2111, 2116-
`17 (the protein-encoding information of a nucleic acid).
`30 See, e.g., Parke-Davis & Co. v. H.K. Mulford Co., 189 F. 95, 103-04 (S.D.N.Y. 1911) (the alkalinity of a
`chemical compound); Marden, 47 F.2d at 958 (the ductility or malleability of metals); Funk Bros., 333 U.S.
`at 130 (“The qualities of these bacteria, like the heat of the sun, electricity, or the qualities of metals, are
`part of the store-house of knowledge of all men. They are manifestations of laws of nature, free to all men
`and reserved exclusively to none.”).
`31 See, e.g., Roslin, 750 F.3d at 1338 (phenotype, including functional and structural characteristics, e.g.,
`the shape, size, color, and behavior of an organism).
`32 See, e.g., Chakrabarty, 447 U.S. at 305 and n.1 (the physical presence of plasmids in a bacterial cell);
`Parke-Davis, 189 F. at 100, 103 (claimed chemical was a “nonsalt” and a “crystalline substance”); Myriad,
`133 S. Ct. at 2116, 2119 (nucleotide sequence of DNA); Roslin, 750 F.3d at 1338-39 (the genetic makeup
`(genotype) of a cell or