Commissioner for Patents
`United States Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`www.uspto.gov
`
`MEMORANDUM
`
`DATE:
`
`May 4, 2016
`
`TO:
`
`FROM:
`
`~~J}ia.~ing Corps
`
`_...-,(~~
`
`Deputy Commissioner
`
`For Patent Examination Policy
`
`
`SUBJECT: Formulating a Subject Matter Eligibility Rejection and Evaluating the
`Applicant's Response to a Subject Matter Eligibility Rejection
`
`The purpose of this memorandum is to provide examination instructions to the Patent Examining
`Corps relating to subject matter eligibility of claims under 35 U.S.C. § 101. In particular, this
`memorandum addresses: (i) how examiners should formulate a subject matter eligibility
`rejection under§ 101, and (ii) how examiners should evaluate an applicant response to such a
`rejection. These instructions are intended to assist examiners in applying the 2014 Interim
`Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance) and the July 2015
`Update: Subject Matter Eligibility (July 2015 Updat~). Training will be provided to illustrate the
`points made in this memorandum.
`
`I. Executive Summary
`
`Following a finding of ineligibility under the two-part analysis des.cribed in the Interim
`Eligibility Guidance, when an examiner determines that a claim is directed to an abstract idea
`(Step 2A), the rejection should identify the abstract idea as it is recited (i.e., set forth or
`described) in the claim and explain why it corresponds to a concept that the courts have
`identified as an abstract idea. Similarly, when an examiner determines that a claim is directed to
`a law of nature or a natural phenomenon (Step 2A), the rejection should identify the law of
`nature or natural phenomenon as it is recited (i.e., set forth or described) in the claim and explain
`using a reasoned rationale why it is considered a law of nature or natural phenomenon. This is
`discussed in greater detail in section IIA, pages 2 and 3, of this memorandum.
`
`For the second part of the analysis (Step 2B), the rejection should identify the additional
`elements in the claim and explain why the elements taken individually and in combination do not
`amount to a claim as a whole that is significantly more than the exception identified in Step 2A.
`For instance, when the examiner has concluded that certain claim elements recite well­
`understood, routine, conventional activities in the relevant field of art, the rejection should
`explain why the courts have recognized, or those in the field would recognize, the additional
`elements when taken both individually and as a combination to be well-understood, routine,
`
`1
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`EX. 1006
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`conventional activities. This is discussed in greater detail in section IIB, pages 3 and 4, of this
`memorandum.
`
`Examiners are reminded that examples issued by the Office in conjunction with the Interim
`Eligibility Guidance are intended to show exemplary analyses only and should not be used as a
`basis for a subject matter eligibility rejection or relied upon in the same manner as a decision
`from a court. This is noted in section IIC, page 5, of this memorandum.
`
`When evaluating a response by applicant to a subject matter eligibility rejection, examiners must
`carefully consider all of applicant's arguments and evidence presented to rebut the rejection. If
`applicant properly challenges the examiner's findings, the rejection should be withdrawn or, if
`the examiner deems it appropriate to maintain the rejection, a rebuttal must be provided in the
`next Office action. This is discussed in greater detail in section III, pages 5 and 6, of this
`memorandum.
`
`II. Formulating a § 101 Rejection
`After determining what the applicant invented and establishing the broadest reasonable
`interpretation of the claimed invention, the eligibility of each claim should be evaluated as a
`whole using the two-step analysis detailed in the Interim Eligibility Guidance. If it is determined
`that the claim does not recite eligible subject matter, a rejection under § 101 is appropriate.
`When making the rejection, the Office action must provide an explanation as to why each claim
`is unpatentable, which must be sufficiently clear and specific to provide applicant sufficient
`notice of the reasons for ineligibility and enable the applicant to effectively respond. A subject
`matter eligibility rejection under Step 2 should:
`
`•
`
`•
`
`•
`
`identify the judicial exception by referring to what is recited (i.e., set forth or described)
`in the claim and explain why it is considered an exception;
`
`identify any additional elements (specifically point to claim features/limitations/steps)
`recited in the claim beyond the identified judicial exception; and
`
`explain the reason(s) that the additional elements taken individually, and also taken as a
`combination, do not result in the claim as a whole amounting to significantly more than
`the judicial exception.
`
`A. When making a rejection, identify and explain the judicial exception recited in the claim
`(Step 2A)
`
`A subject matter eligibility rejection should point to the specific claim limitation(s) that recites
`(i.e., sets forth or describes) the judicial exception. The rejection must identify the specific claim
`limitations and explain why those claim limitations set forth a judicial exception (e.g., an
`abstract idea). Where the claim describes, but does not expressly set forth, the judicial
`exception, the rejection must also explain what subject matter those limitations describe, and
`why the described subject matter is a judicial exception.
`
`When the examiner has determined the claim recites an abstract idea, the rejection should
`identify the abstract idea as it is recited (i.e., set forth or described) in the claim, and explain why
`it corresponds to a concept that the courts have identified as an abstract idea. See, for example,
`the concepts identified on the July 2015 Update: Interim Eligibility Guidance Quick Reference
`Sheet, page 2. Citing to an appropriate court decision that supports the identification of the
`
`2
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`2
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`subject matter recited in the claim language as an abstract idea is a best practice that will advance
`prosecution. Examiners should be familiar with any cited decision relied upon in making or
`maintaining a rejection to ensure that the rejection is reasonably tied to the facts of the case and
`to avoid relying upon language taken out of context. Examiners should not go beyond those
`concepts that are similar to what the courts have identified as abstract ideas. Examiners are
`reminded that a chart of court decisions is available on the USPTO's Internet Web site.
`
`Sample explanation: The claim recites the steps of sorting information by X, which is an
`abstract idea similar to the concepts that have been identified as abstract by the courts,
`such as organizing information through mathematical correlations in Digitech or data
`recognition and storage in Content Extraction.
`
`When the examiner has determined the claim recites a law of nature or a natural phenomenon,
`the rejection should identify the law of nature or natural phenomenon as it is recited (i.e., set
`forth or described) in the claim and explain using a reasoned rationale why it is considered a law
`of nature or natural phenomenon.
`
`Sample explanation: The claim recites the correlation of X, and X is a law of nature
`because it describes a consequence of natural processes in the human body, e.g., the
`naturally-occurring relationship between the presence of Y and the manifestation of Z.
`Sample explanation: The claim recites X, which is a natural phenomenon because it
`occurs in nature and exists in principle apart from any human action.
`
`When the examiner has determined the claim recites a product of nature, the rejection should
`identify the exception as it is recited (i.e., set forth or described) in the claim, and explain using a
`reasoned rationale why the product does not have markedly different characteristics from its
`naturally occurring counterpart in its natural state.
`
`Sample explanation: The claim recites X, which as explained in the specification was
`isolated from naturally occurring Y. Xis a nature-based product, so it is compared to its
`closest naturally occurring counterpart (X in its natural state) to determine if it has
`markedly different characteristics. Because there is no indication in the record that
`isolation of X has resulted in a marked difference in structure, function, or other
`properties as compared to its counterpart, X is a product of nature exception.
`
`B. When making a rejection, explain why the additional claim elements do not result in the
`claim as a whole amounting to significantly more than the judicial exception (Step 2B)
`
`After identifying the judicial exception in the rejection, identify any additional elements
`(features/limitations/steps) recited in the claim beyond the judicial exception and explain why
`they do not add significantly more to the exception. The explanation should address the
`additional elements both individually and as a combination when determining whether the claim
`as whole recites eligible subject matter. It is important to remember that a new combination of
`steps in a process may be patent eligible even though all the steps of the combination were
`individually well known and in common use before the combination was made (Diehr). Thus, it
`is particularly critical to address the combination of additional elements, because while
`individually-viewed elements may not appear to add significantly more, those additional
`elements when viewed in combination may amount to significantly more than the exception by
`meaningfully limiting the judicial exception.
`
`3
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`
`3
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`A rejection should be made only if it is readily apparent to an examiner relying on his or her
`expertise in the art in the Step 2B inquiry that the additional elements do not amount to claiming
`significantly more than the recited judicial exception. When making a rejection, it is important
`for the examiner to explain the rationale underlying his or her conclusion so that applicant can
`effectively respond. On the other hand, when appropriate, the examiner should explain why the
`additional elements provide an inventive concept by adding a meaningful limitation to the
`claimed exception. See the Interim Eligibility Guidance for a listing of considerations that courts
`have found to qualify, and to not qualify, as significantly more than an exception.
`
`For example, when the examiner has concluded that particular claim limitations are well­
`understood, routine, conventional activities (or elements) to those in the relevant field, the
`rejection should explain why the courts have recognized, or those in the relevant field of art
`would recognize, those claim limitations as being well-understood, routine, conventional
`activities. A prior art search should not be necessary to resolve whether the additional element is
`a well-understood, routine, conventional activity because lack of novelty (i.e., finding the
`element in the prior art) does not necessarily show that an element is well-understood, routine,
`conventional activity previously engaged in by those in the relevant field. For example, even if a
`particular laboratory technique was discussed in several widely-read scientific journals or used
`by a few scientists, mere knowledge of the particular laboratory technique or use of the particular
`laboratory technique by a few scientists is not sufficient to make the use of the particular
`laboratory technique routine or conventional in the relevant field. Instead, the evaluation turns on
`whether the use of the particular laboratory technique was well-understood, routine, conventional
`activity previously engaged in by scientists in the field. If it is determined that the additional
`element is widely prevalent and its combination with any other additional elements is well­
`understood, routine, conventional activity, the examiner should provide a reasoned explanation
`that supports that conclusion.
`
`For claim limitations that recite a generic computer component performing generic computer
`functions at a high level of generality, such as using the Internet to gather data, examiners can
`explain why these generic computing functions do not meaningfully limit the claim. The July
`2015 Update lists some computer functions that the courts have recognized as well-understood,
`routine, conventional functions when they are claimed in a merely generic manner. This listing is
`not meant to imply that all computer functions are well-understood, routine, conventional
`functions, or that a claim reciting a generic computer component performing a generic computer
`function is necessarily ineligible. Examiners should keep in mind that the courts have held
`computer-implemented processes to be significantly more than an abstract idea (and thus
`eligible), where generic computer components are able in combination to perform functions that
`are not merely generic (DDR).
`
`For claim limitations that add insignificant extrasolution activity to the judicial exception (e.g.,
`mere data gathering in conjunction with a law of nature or abstract idea, or that generally link the
`use of the judicial exception to a particular technological environment or field of use), examiners
`can explain why they do not meaningfully limit the claim. For example, adding a final step of
`storing data to a process that only recites computing the area of a space (a mathematical
`relationship) does not add a meaningful limitation to the process of computing the area. As
`another example, employing well-known computer functions to execute an abstract idea, even
`when limiting the use of the idea to one particular environment, does not add significantly more,
`
`4
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`4
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`similar to how limiting the computer implemented abstract idea in Flook to petrochemical and
`oil-refining industries was insufficient.
`
`C. Examples should not be relied upon in§ I OJ rejections
`
`The USPTO issued examples in conjunction with the Interim Eligibility Guidance, including
`Examples: Nature-Based Products; Examples: Abstract Ideas; July 2015 Update Appendix I:
`Examples; and, Examples: Life Sciences (issued in May 2016). These examples, many of which
`are hypothetical, were drafted to show exemplary analyses under the Interim Eligibility
`Guidance and are intended to be illustrative of the analysis only. While some of the fact patterns
`draw from U.S. Supreme Court and U.S. Court of Appeals for the Federal Circuit decisions, the
`examples do not carry the weight of court decisions. Therefore, the examples should not be used
`as a basis for a subject matter eligibility rejection. Additionally, while it would be acceptable for
`applicants to cite an example in support of an argument for finding eligibility in an appropriate
`factual situation, applicants should not be required to model their claims or responses after the
`examples to attain eligibility.
`
`III. Evaluating Applicant's Response
`
`In response to a rejection based on failure to claim patent-eligible subj~ct matter, applicant may:
`(i) amend the claim, e.g., to add additional elements or modify existing elements so that the
`claim as a whole amounts to significantly more than the judicial exception, and/or (ii) present
`persuasive arguments or evidence based on a good faith belief as to why the rejection is in error.
`When evaluating a response, examiners must carefully consider all of applicant's arguments and
`evidence rebutting the subject matter eligibility rejection.
`
`If applicant's claim amendment(s) and/or argument(s) persuasively establish that the claim is not
`directed to a judicial exception or is directed to significantly more than a judicial exception, the
`rejection should be withdrawn. Applicant may argue that a claim is eligible because the claim as
`a whole amounts to significantly more than the judicial exception when the additional elements
`are considered both individually and in combination. When an additional element is considered
`individually by the examiner, the additional element may be enough to qualify as "significantly
`more" if it meaningfully limits the judicial exception, improves another technology or technical
`field, improves the functioning of a computer itself, or adds a specific limitation other than what
`is well-understood, routine, conventional activity in the field or unconventional steps that confine
`the claim to a particular useful application.
`
`In addition, even if an element does not amount to significantly more on its own (e.g., because it
`is merely a generic computer component performing generic computer functions), it can still
`amount to significantly more when considered in combination with the other elements of the
`claim. For example, generic computer components that individually perform merely generic
`computer functions (e.g., a CPU that performs mathematical calculations or a clock that produces
`time data) in some instances are able in combination to perform functions that are not generic
`computer functions and therefore amount to significantly more than an abstract idea (and are thus
`eligible).
`
`If applicant properly challenges the examiner's findings but the examiner deems it appropriate to
`maintain the rejection, a rebuttal must be provided in the next Office action. Several examples of
`appropriate examiner responses are provided below:
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`5
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`•
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`•
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`If applicant challenges the identification of an abstract idea that was based on a court case
`and the challenge is not persuasive, an appropriate response would be an explanation as
`to why the abstract idea identified in the claim is similar to the concept in the cited case.
`If the original rejection did not identify a Supreme Court or Federal Circuit decision in
`which a similar abstract idea was found and applicant challenges identification of the
`abstract idea, the examiner would need to point to a case in which a similar abstract idea
`was identified and explain why the abstract idea recited in the claim corresponds to the
`abstract idea identified in the case to maintain the rejection. Citation to a case that
`supports the original rationale would not be considered a new ground of rejection, unless
`there is a change to the basic thrust of the rejection. See MPEP 1207.03(a) for a
`discussion of new grounds of rejection.
`
`If applicant responds to an examiner's assertion that something is well-known, routine,
`conventional activity with a specific argument or evidence that the additional elements in
`a claim are not well-understood, routine, conventional activities previously engaged in by
`those in the relevant art, the examiner should reevaluate whether it is readily apparent
`that the additional elements are in actuality well-known, routine, conventional activities
`to those who work in the relevant field. It is especially necessary for the examiner to
`fully reevaluate his or her position when such additional elements are not discussed in the
`specification as being known generic functions/components/activities or not treated by
`the courts as well-understood, routine, conventional activities. If the rejection is to be
`maintained, the examiner should consider whether rebuttal evidence should be provided
`to further support the rejection and clarify the record for appeal. Examples of well­
`understood, routine, conventional claim limitations found by the Supreme Court, include:
`
`o Alice Corp. provides an example of computer functions and components that have
`been treated as conventional. The court describes the use of a computer to create
`electronic records, track multiple transactions, and issue simultaneous instructions
`as purely conventional computer functions and notes that nearly every computer
`has a "data processing system" with a "communications controller" and a "data
`storage unit."
`
`o Mayo provides an example of data gathering that has been treated as well­
`understood, routine, conventional activity. The court explains that scientists
`routinely measured metabolites as part of their investigations into the
`relationships between metabolite levels and efficacy and toxicity of thiopurine
`compounds and finding that steps of administering a drug and determining
`metabolite levels consist of well-understood, routine, conventional activity
`already engaged in by the scientific community.
`
`•
`
`If applicant amends a claim to add a generic computer or generic computer components
`and asserts that the claim recites significantly more because the generic computer is
`'specially programmed' (as in Alappat, now considered superseded) or is a 'particular
`machine' (as in Bilski), the examiner should look at whether the added elements provide
`significantly more than the judicial exception. Merely adding a generic computer,
`generic computer components, or a programmed computer to perform generic computer
`functions does not automatically overcome an eligibility rejection. Alice Corp.
`
`•
`
`If applicant argues that the claim is specific and does not preempt all applications of the
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`6
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`exception, an appropriate response would be to explain that preemption is not a stand­
`alone test for eligibility. Questions of preemption are inherent in and resolved by the
`two-part framework from Alice Corp. and Mayo, as explained by the Federal Circuit in
`OJP and Sequenom. Moreover, while a preemptive claim may be ineligible, the absence
`of complete preemption does not demonstrate that a claim is eligible.
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`7
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`7
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