TRADING TECH EXHIBIT 2033
`IBG ET AL. v. TRADING TECH
`CBM2016-00009
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`

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`Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations
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`74619
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`ACTION: Examination guidance; request
`for comments.
`
`SUMMARY: The United States Patent and
`Trademark Office (USPTO or Office) has
`prepared interim guidance (2014
`Interim Guidance on Patent Subject
`Matter Eligibility, called ‘‘Interim
`Eligibility Guidance’’) for use by USPTO
`personnel in determining subject matter
`eligibility under 35 U.S.C. 101 in view
`of recent decisions by the U.S. Supreme
`Court (Supreme Court). This Interim
`Eligibility Guidance supplements the
`June 25, 2014, Preliminary Examination
`Instructions in view of the Supreme
`Court decision in Alice Corp. (June 2014
`Preliminary Instructions) and
`supersedes the March 4, 2014,
`Procedure For Subject Matter Eligibility
`Analysis Of Claims Reciting Or
`Involving Laws Of Nature/Natural
`Principles, Natural Phenomena, And/Or
`Natural Products (March 2014
`Procedure) issued in view of the
`Supreme Court decisions in Myriad and
`Mayo. The USPTO is seeking public
`comment on this Interim Eligibility
`Guidance along with additional
`suggestions on claim examples for
`explanatory example sets.
`DATES: Effective Date: This Interim
`Eligibility Guidance is effective on
`December 16, 2014. This Interim
`Eligibility Guidance applies to all
`applications filed before, on or after
`December 16, 2014.
`Comment Deadline Date: To be
`ensured of consideration, written
`comments must be received on or before
`March 16, 2015.
`ADDRESSES: Comments on this Interim
`Eligibility Guidance must be sent by
`electronic mail message over the
`Internet addressed to: 2014_interim_
`guidance@uspto.gov. Electronic
`comments submitted in plain text are
`preferred, but also may be submitted in
`ADOBE® portable document format or
`MICROSOFT WORD® format. The
`comments will be available for viewing
`via the Office’s Internet Web site (http://
`www.uspto.gov). Because comments will
`be made available for public inspection,
`information that the submitter does not
`desire to make public, such as an
`address or phone number, should not be
`included in the comments.
`FOR FURTHER INFORMATION CONTACT: Raul
`Tamayo, Senior Legal Advisor, Office of
`Patent Legal Administration, by
`telephone at 571–272–7728, or Michael
`Cygan, Senior Legal Advisor, Office of
`Patent Legal Administration, by
`telephone at 571–272–7700.
`SUPPLEMENTARY INFORMATION: Section
`2106 of the Manual of Patent Examining
`Procedure (MPEP) sets forth guidance
`
`for use by USPTO personnel in
`determining subject matter eligibility
`under 35 U.S.C. 101. See MPEP 2106
`(9th ed. 2014). The USPTO has prepared
`this Interim Eligibility Guidance for use
`by USPTO personnel in determining
`subject matter eligibility under 35
`U.S.C. 101 in view of recent decisions
`by the Supreme Court. The following
`Interim Eligibility Guidance on patent
`subject matter eligibility under 35
`U.S.C. 101 supplements the June 25,
`2014, Preliminary Examination
`Instructions in view of the Supreme
`Court Decision in Alice Corporation Pty.
`Ltd. v. CLS Bank International, et al.1
`(June 2014 Preliminary Instructions)
`and supersedes the March 4, 2014,
`Procedure For Subject Matter Eligibility
`Analysis Of Claims Reciting Or
`Involving Laws Of Nature/Natural
`Principles, Natural Phenomena, And/Or
`Natural Products (March 2014
`Procedure) 2 issued in view of the
`Supreme Court decisions in Association
`for Molecular Pathology v. Myriad
`Genetics, Inc.3 and Mayo Collaborative
`Services v. Prometheus Laboratories
`Inc.4 Implementation of examination
`guidance on eligibility will be an
`iterative process continuing with
`periodic supplements based on
`developments in patent subject matter
`eligibility jurisprudence 5 and public
`feedback.
`The USPTO is seeking written
`comments on this guidance, as well as
`additional suggestions for claim
`examples to use for examiner training.
`Further, the USPTO plans to hold a
`public forum in mid-January 2015 in
`
`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).
`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).
`
`order to discuss the guidance and next
`steps and to receive additional oral
`input. When the date and location are
`finalized, notice of the forum will be
`provided on the Office’s Internet Web
`site (http://www.uspto.gov).
`This Interim Eligibility Guidance does
`not constitute substantive rulemaking
`and does not have the force and effect
`of law. This Interim Eligibility Guidance
`sets out the Office’s interpretation of the
`subject matter eligibility requirements of
`35 U.S.C. 101 in view of recent
`decisions by the Supreme Court and the
`U.S. Court of Appeals for the Federal
`Circuit (Federal Circuit), and advises the
`public and Office personnel on how
`these court decisions impact the
`provisions of MPEP 2105, 2106 and
`2106.01. This Interim Eligibility
`Guidance has been developed as a
`matter of internal Office management
`and is not intended to create any right
`or benefit, substantive or procedural,
`enforceable by any party against the
`Office. Rejections will continue to be
`based upon the substantive law, and it
`is these rejections that are appealable.
`Failure of Office personnel to follow
`this Interim Eligibility Guidance is not,
`in itself, a proper basis for either an
`appeal or a petition.
`This Interim Eligibility Guidance
`offers a comprehensive view of subject
`matter eligibility in line with Alice
`Corp, Myriad, Mayo, and the related
`body of case law, and is responsive to
`the public comments received
`pertaining to the March 2014 Procedure
`and the June 2014 Preliminary
`Instructions (see the Notice of Forum on
`the Guidance for Determining Subject
`Matter Eligibility of Claims Reciting or
`Involving Laws of Nature, Natural
`Phenomena, and Natural Products, 79
`FR 21736 (Apr. 17, 2014) and the
`Request for Comments and Extension of
`Comment Period on Examination
`Instruction and Guidance Pertaining to
`Patent-Eligible Subject Matter, 79 FR
`36786 (June 30, 2014)). In conjunction
`with this Interim Eligibility Guidance, a
`set of explanatory examples relating to
`nature-based products is being released
`to replace the prior examples issued
`with the March 2014 Procedure and the
`related training. The explanatory
`examples relating to nature-based
`products address themes raised in the
`public comments and adopt many
`suggestions from the comments.
`Additional explanatory example sets
`relating to claims that do and do not
`amount to significantly more than a
`judicial exception are being developed
`and will be issued at a future date,
`taking into account suggestions already
`received from the public comments,
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`Page 2 of 16
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`74620
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`Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations
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`future public comments, and any further
`judicial developments.
`The June 2014 Preliminary
`Instructions superseded MPEP sections
`2106(II)(A) and 2106(II)(B). MPEP 2105
`is also superseded by this Interim
`Eligibility Guidance to the extent that it
`suggests that ‘‘mere human
`intervention’’ necessarily results in
`eligible subject matter. MPEP 2106.01 is
`additionally now superseded with this
`interim guidance. Examiners should
`continue to follow the MPEP for all
`other examination instructions. The
`following sections pertain to examining
`for patent subject matter eligibility with
`details on determining what applicant
`invented and making a rejection under
`35 U.S.C. 101 and should be reviewed
`closely as they are not duplicated in this
`Interim Eligibility Guidance:
`• MPEP 2103: Patent Examination
`Process
`D 2103(I): Determine What Applicant
`Has Invented and Is Seeking to
`Patent
`D 2103(II): Conduct a Thorough Search
`of the Prior Art
`D 2103(III): Determine Whether the
`Claimed Invention Complies With
`
`35 U.S.C. 101
`D 2103(IV): Evaluate Application for
`Compliance With 35 U.S.C. 112
`D 2103(V): Determine Whether the
`Claimed Invention Complies With
`35 U.S.C. 102 and 103
`D 2103(VI): Clearly Communicate
`Findings, Conclusions, and Their
`Bases
`• MPEP 2104: Patentable Subject Matter
`• MPEP 2105: Patentable Subject
`Matter—Living Subject Matter 6
`• MPEP 2106: Patent Subject Matter
`Eligibility
`D 2106(I): The Four Categories of
`Statutory Subject Matter
`D 2106(II): Judicial Exceptions to the
`Four Categories (not subsections
`(II)(A) and (II)(B))
`D 2106(III): Establish on the Record a
`Prima Facie Case
`
`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 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).
`
`The current version of the MPEP (9th
`ed., March 2014) incorporates patent
`subject matter eligibility guidance
`issued as of November 2013.
`This Interim Eligibility Guidance is
`divided into the following sections:
`Flowchart: Eligibility Test for
`Products and Processes;
`Part I: Two-part Analysis for Judicial
`Exceptions;
`Part II: Complete Examination;
`Part III: Sample Analysis; and
`Part IV: Summaries of Court Decisions
`Relating to Laws of Nature, Natural
`Phenomena, and Abstract Ideas.
`The following flowchart illustrates the
`subject matter eligibility analysis for
`products and processes to be used
`during examination for evaluating
`whether a claim is drawn to patent-
`eligible subject matter. It is recognized
`that under the controlling legal
`precedent there may be variations in the
`precise contours of the analysis for
`subject matter eligibility that will still
`achieve the same end result. The
`analysis set forth herein promotes
`examination efficiency and consistency
`across all technologies.
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`Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations
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`74621
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`2014 Interim Eligibility Guidance: In
`accordance with the existing two-step
`analysis for patent subject matter
`eligibility under 35 U.S.C. 101
`explained in MPEP 2106, the claimed
`invention (Step 1) ‘‘must be directed to
`
`one of the four statutory categories’’ and
`(Step 2) ‘‘must not be wholly directed to
`subject matter encompassing a judicially
`recognized exception.’’ Referring to the
`attached flowchart titled Subject Matter
`Eligibility Test for Products and
`
`Processes, Step 1 is represented in
`diamond (1), which is explained in
`MPEP 2106(I). Step 2 is represented in
`diamonds (2A) and (2B) and is the
`subject of this Interim Eligibility
`Guidance. Step 2 is the two-part
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`74622
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`Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations
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`analysis from Alice Corp.7 (also called
`the Mayo test) for claims directed to
`laws of nature, natural phenomena, and
`abstract ideas (the judicially recognized
`exceptions).
`I. Two-Part Analysis for Judicial
`Exceptions
`A. Flowchart Step 2A (Part 1 Mayo
`Test)—Determine whether the claim is
`directed to a law of nature, a natural
`phenomenon, or an abstract idea
`(judicial exceptions).
`After determining what applicant has
`invented by reviewing the entire
`application disclosure and construing
`the claims in accordance with their
`broadest reasonable interpretation
`(MPEP 2103), determine whether the
`claim as a whole is directed to a judicial
`exception. A claim to a process,
`machine, manufacture or composition of
`matter (Step 1: YES) that is not directed
`to any judicial exceptions (Step 2A: NO)
`is eligible and needs no further
`eligibility analysis. A claim that is
`directed to at least one exception (Step
`2A: YES) requires further analysis to
`determine whether the claim recites a
`patent-eligible application of the
`exception (Step 2B).
`1. Determine What the Claim Is
`‘‘Directed to’’
`A claim is directed to a judicial
`exception when a law of nature, a
`natural phenomenon, or an abstract idea
`is recited (i.e., set forth or described) in
`the claim. Such a claim requires closer
`scrutiny for eligibility because of the
`risk that it will ‘‘tie up’’ 8 the excepted
`subject matter and pre-empt others from
`using the law of nature, natural
`phenomenon, or abstract idea. Courts
`tread carefully in scrutinizing such
`claims because at some level all
`inventions embody, use, reflect, rest
`upon, or apply a law of nature, natural
`phenomenon, or abstract idea.9 To
`properly interpret the claim, it is
`important to understand what the
`
`7 Alice Corp., 134 S. Ct. at 2355.
`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)).
`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).
`
`applicant has invented and is seeking to
`patent.
`For claims that may recite a judicial
`exception, but are directed to inventions
`that clearly do not seek to tie up the
`judicial exception, see Section I.B.3.
`regarding a streamlined eligibility
`analysis.
`2. Identify the Judicial Exception
`Recited in the Claim
`MPEP 2106(II) provides a detailed
`explanation of the judicial exceptions
`and their legal bases. It should be noted
`that there are no bright lines between
`the types of exceptions because many of
`these concepts can fall under several
`exceptions. For example, mathematical
`formulas are considered to be an
`exception as they express a scientific
`truth, but have been labelled by the
`courts as both abstract ideas and laws of
`nature. Likewise, ‘‘products of nature’’
`are considered to be an exception
`because they tie up the use of naturally
`occurring things, but have been labelled
`as both laws of nature and natural
`phenomena. Thus, it is sufficient for
`this analysis to identify that the claimed
`concept aligns with at least one judicial
`exception.
`Laws of nature and natural
`phenomena, as identified by the courts,
`include naturally occurring principles/
`substances and substances that do not
`have markedly different characteristics
`compared to what occurs in nature. See
`Section I.A.3. for a discussion of the
`markedly different characteristics
`analysis used to determine whether a
`claim that includes a nature-based
`product limitation recites an exception.
`The types of concepts courts have found
`to be laws of nature and natural
`phenomena are shown by these cases,
`which are intended to be illustrative
`and not limiting:
`• An isolated DNA (Myriad: see
`Section III, Example 2);
`• a correlation that is the
`consequence of how a certain
`compound is metabolized by the body
`(Mayo: see Section III, Example 5);
`• electromagnetism to transmit
`signals (Morse: 10 see Section IV.A.1.);
`and
`• the chemical principle underlying
`the union between fatty elements and
`water (Tilghman: 11 see Section IV.A.2.).
`Abstract ideas have been identified by
`the courts by way of example, including
`fundamental economic practices, certain
`methods of organizing human activities,
`an idea ‘of itself,’ and mathematical
`relationships/formulas.12 The types of
`
`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.
`
`concepts courts have found to be
`abstract ideas are shown by these cases,
`which are intended to be illustrative
`and not limiting:
`• Mitigating settlement risk (Alice:
`see Section III, Example 6);
`• hedging (Bilski: 13 see Section
`IV.A.5.);
`• creating a contractual relationship
`(buySAFE: 14 see Section IV.C.3.);
`• using advertising as an exchange or
`currency (Ultramercial: 15 see Section
`IV.C.4.);
`• processing information through a
`clearinghouse (Dealertrack: 16 see
`Section IV.B.3.);
`• comparing new and stored
`information and using rules to identify
`options (SmartGene: 17 see Section
`IV.B.4.);
`• using categories to organize, store
`and transmit information (Cyberfone: 18
`see Section IV.B.5.);
`• organizing information through
`mathematical correlations (Digitech: 19
`see Section IV.C.1.);
`• managing a game of bingo (Planet
`Bingo: 20 see Section IV.C.2.);
`• the Arrhenius equation for
`calculating the cure time of rubber
`(Diehr: 21 see Section III, Example 3);
`• a formula for updating alarm limits
`(Flook: 22 see Section III, Example 4);
`• a mathematical formula relating to
`standing wave phenomena (Mackay
`Radio: 23 see Section IV.A.3.); and
`• a mathematical procedure for
`converting one form of numerical
`representation to another (Benson: 24 see
`Section IV.A.4.)
`3. Nature-Based Products
`a. Determine Whether the Markedly
`Different Characteristics Analysis Is
`Needed To Evaluate a Nature-Based
`Product Limitation Recited in a Claim
`Nature-based products, as used
`herein, include both eligible and
`
`13 Bilski v. Kappos, 561 U.S. 593 (2010).
`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).
`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.
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`Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations
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`74623
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`ineligible products and merely refer to
`the types of products subject to the
`markedly different characteristics
`analysis used to identify ‘‘product of
`nature’’ exceptions. Courts have held
`that naturally occurring products and
`some man-made products that are
`essentially no different from a naturally
`occurring product are ‘‘products of
`nature’’ 25 that fall under the laws of
`nature or natural phenomena exception.
`To determine whether a claim that
`includes a nature-based product
`limitation recites a ‘‘product of nature’’
`exception, use the markedly different
`characteristics analysis to evaluate the
`nature-based product limitation
`(discussed in section I.A.3.b). A claim
`that recites a nature-based product
`limitation that does not exhibit
`markedly different characteristics from
`its naturally occurring counterpart in its
`natural state is directed to a ‘‘product of
`nature’’ exception (Step 2A: YES).
`Care should be taken not to overly
`extend the markedly different
`characteristics analysis to products that
`when viewed as a whole are not nature-
`based. For claims that recite a nature-
`based product limitation (which may or
`may not be a ‘‘product of nature’’
`exception) but are directed to inventions
`that clearly do not seek to tie up any
`judicial exception, see Section I.B.3.
`regarding a streamlined eligibility
`analysis. In such cases, it would not be
`necessary to conduct a markedly
`different characteristics analysis.
`A nature-based product can be
`claimed by itself (e.g., ‘‘a Lactobacillus
`bacterium’’) or as one or more
`limitations of a claim (e.g., ‘‘a probiotic
`composition comprising a mixture of
`Lactobacillus and milk in a container’’).
`The markedly different characteristics
`analysis should be applied only to the
`nature-based product limitations in the
`claim to determine whether the nature-
`based products are ‘‘product of nature’’
`exceptions. When the nature-based
`product is produced by combining
`multiple components, the markedly
`different characteristics analysis should
`be applied to the resultant nature-based
`combination, rather than its component
`parts. In the example above, the mixture
`of Lactobacillus and milk should be
`analyzed for markedly different
`characteristics, rather than the
`Lactobacillus separately and the milk
`separately. The container would not be
`subject to the markedly different
`characteristics analysis as it is not a
`nature-based product, but would be
`evaluated in Step 2B if it is determined
`that the mixture of Lactobacillus and
`milk does not have markedly different
`
`25 Myriad, 133 S. Ct. at 2111.
`
`characteristics from any naturally
`occurring counterpart and thus is a
`‘‘product of nature’’ exception.
`For a product-by-process claim, the
`analysis turns on whether the nature-
`based product in the claim has
`markedly different characteristics from
`its naturally occurring counterpart. (See
`MPEP 2113 for product-by-process
`claims.)
`A process claim is not subject to the
`markedly different analysis for nature-
`based products used in the process,
`except in the limited situation where a
`process claim is drafted in such a way 26
`that there is no difference in substance
`from a product claim (e.g., ‘‘a method of
`providing an apple.’’).
`b. Markedly Different Characteristics
`Analysis: Structure, Function and/or
`Other Properties 27
`The markedly different characteristics
`analysis compares the nature-based
`product limitation to its naturally
`occurring counterpart in its natural
`state. When there is no naturally
`occurring counterpart to the nature-
`based product, the comparison should
`be made to the closest naturally
`occurring counterpart. In the case of a
`nature-based combination, the closest
`counterpart may be the individual
`nature-based components that form the
`combination, i.e., the characteristics of
`the claimed nature-based combination
`are compared to the characteristics of
`the components in their natural state.
`Markedly different characteristics can
`be expressed as the product’s structure,
`function, and/or other properties,28 and
`
`26 Alice Corp., 134 S. Ct. at 2360.
`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.)).
`
`will be evaluated based on what is
`recited in the claim on a case-by-case
`basis. As seen by the examples that are
`being released in conjunction with this
`Interim Eligibility Guidance, even a
`small change can result in markedly
`different characteristics from the
`product’s naturally occurring
`counterpart. In accordance with this
`analysis, a product that is purified or
`isolated, for example, will be eligible
`when there is a resultant change in
`characteristics sufficient to show a
`marked difference from the product’s
`naturally occurring counterpart. If the
`claim recites a nature-based product
`limitation that does not exhibit
`markedly different characteristics, the
`claim is directed to a ‘‘product of
`nature’’ exception (a law of nature or
`naturally occurring phenomenon), and
`the claim will require further analysis to
`determine eligibility based on whether
`additional elements add significantly
`more to the exception.
`Non-limiting examples of the types of
`characteristics considered by the courts
`when determining whether there is a
`marked difference include:
`• Biological or pharmacological
`functions or activities; 29
`• Chemical and physical
`properties; 30
`• Phenotype, including functional
`and structural characteristics; 31 and
`• Structure and form, whether
`chemical, genetic or physical.32
`If the claim includes a nature-based
`product that has markedly different
`characteristics, the claim does not recite
`a ‘‘product of nature’’ exception and is
`eligible (Step 2A: NO) unless the claim
`
`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
`organism).
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`74624
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`Federal Register / Vol. 79, No. 241 / Tuesday, December 16, 2014 / Rules and Regulations
`
`recites another exception (such as a law
`of nature or abstract idea, or a different
`natural phenomenon). If the claim
`includes a product having no markedly
`different characteristics from the
`product’s naturally occurring
`counterpart in its natural state, the
`claim is directed to an exception (Step
`2A: YES), and the eligibility analysis
`must proceed to Step 2B to determine if
`any additional elements in the claim
`add significantly more to the exception.
`For claims that are to a single nature-
`based product, once a markedly
`different characteristic in that product is
`shown, no further analysis would be
`necessary for eligibility because no
`‘‘product of nature’’ exception is recited
`(i.e., Step 2B is not necessary because
`the answer to Step 2A is NO). This is
`a change from prior guidance because
`the inquiry as to whether the claim
`amounts to significantly more than a
`‘‘product of nature’’ exception is not
`relevant to claims that do not recite an
`exception. Thus, a claim can be found
`eligible based solely on a showing that
`the nature-based product in the claim
`has markedly different characteristics
`and thus is not a ‘‘product of nature’’
`exception, when no other exception is
`recited in the claim.
`If a rejection under 35 U.S.C. 101 is
`ultimately made, the rejection should
`identify the exception as it is recited
`(i.e., set forth or described) in the claim,
`and explain why it is an exception
`providing reasons why the product does
`not have markedly different
`characteristics from its naturally
`occurring counterpart in its natural
`state.
`B. Flowchart Step 2B (Part 2 Mayo
`test)—Determine whether any element,
`or combination of elements, in the claim
`is sufficient to ensure that the claim
`amounts to significantly more than the
`judicial exception.
`A claim directed to a judicial
`exception must be analyzed to
`determine whether the elements of the
`claim, considered both individually and
`as an ordered combination, are
`sufficient to ensure that the claim as a
`whole amounts to significantly more
`than the exception itself—this has been
`termed a search for an ‘‘inventive
`concept.’’ 33 To be patent-eligible, a
`claim that is directed to a judicial
`exception must include additional
`features to ensure that the claim
`describes a process or product that
`applies the exception in a meaningful
`way, such that it is more than a drafting
`effort designed to monopolize the
`exception. It is important to consider
`the claim as whole. Individual elements
`
`33 Alice Corp., 134 S. Ct. at 2357.
`
`viewed on their own may not appear to
`add significantly more to the claim, but