MPEP 2106.07(a)
Formulating a Rejection For Lack of Subject Matter Eligibility

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This is the Ninth Edition of the MPEP, Revision 08.2017, Last Revised in January 2018

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2106.07(a)    Formulating a Rejection For Lack of Subject Matter Eligibility [R-08.2017]

After determining what the applicant invented and establishing the broadest reasonable interpretation of the claimed invention (see MPEP § 2111), the eligibility of each claim should be evaluated as a whole using the analysis detailed in MPEP § 2106. If it is determined that the claim does not recite eligible subject matter, a rejection under 35 U.S.C. 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.

Subject matter eligibility rejections under Step 1 are discussed in MPEP § 706.03(a).

A subject matter eligibility rejection under Step 2 should provide an explanation for each part of the Step 2 analysis:

  • • For Step 2A, the rejection 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. For example, if the claim is directed to 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. Similarly, if the claim is directed to 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.
  • • For Step 2B, the rejection should 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 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, conventional activities.

Under the principles of compact prosecution, regardless of whether a rejection under 35 U.S.C. 101 is made based on lack of subject matter eligibility, a complete examination should be made for every claim under each of the other patentability requirements: 35 U.S.C. 102, 103, 112, and 101 (utility, inventorship and double patenting) and non-statutory double patenting. Thus, examiners should state all non-cumulative reasons and bases for rejecting claims in the first Office action.

I.    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. See MPEP § 2106.04 for more information about Step 2A of the eligibility analysis.

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 in MPEP § 2106.04(a)(2). Citing to an appropriate court decision that supports the identification of the 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, and should avoid relying upon or citing non-precedential decisions unless the facts of the application under examination uniquely match the facts at issue in the non-precedential decisions. Examiners are reminded that a chart of court decisions is available on the USPTO’s Internet website (www.uspto.gov/patent/laws-and- regulations/examination-policy/subject- matter-eligibility ).

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. See MPEP § 2106.04(b) for more information about laws of nature and natural phenomena.

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. See MPEP § 2106.04(b) for more information about products of nature, and MPEP § 2106.04(c) for more information about the markedly different characteristics analysis.

Sample explanation: The claim recites X, which as explained in the specification was isolated from naturally occurring Y. X is 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.

II.    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. Diamond v. Diehr, 450 U.S. 175, 188, 209 USPQ 1, 9 (1981). 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. See MPEP § 2106.05 for more information about Step 2B of the eligibility analysis.

A rejection should be made only if it is readily apparent to an examiner relying on the examiner's 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 the 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 MPEP § 2106.05 for a listing of considerations that courts have found to qualify, and to not qualify, as significantly more than an exception, and MPEP § 2106.07(c) for more information on clarifying the record when a claim is found eligible.

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. That is, the examiner should provide a reasoned explanation that supports that conclusion. See MPEP § 2106.05(d) for more information about well understood, routine, conventional activities and elements.

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. MPEP § 2106.05(d) 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 Holdings, LLC v. Hotels.com, LP, 773 F.3d 1245, 1258-59, 113 USPQ2d 1097, 1106-07 (Fed. Cir. 2014). See MPEP § 2106.05(d) for more information about well understood, routine, conventional activities and elements, and MPEP § 2106.05(f) for more information about generic computing functions that the courts have found to be mere instructions to implement a judicial exception on a computer.

For claim limitations that add insignificant extra-solution 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 two dimensional 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, similar to how limiting the computer implemented abstract idea in Flook to petrochemical and oil-refining industries was insufficient. See Parker v. Flook, 437 U.S. 584, 588-90, 198 USPQ 193, 197-98 (1978) (limiting use of mathematical formula to use in particular industries did not amount to an inventive concept). See MPEP § 2106.05(g) for more information about insignificant extra-solution activity, and MPEP § 2106.05(h) for more information about generally linking use of a judicial exception to a particular technological environment or field of use.

In the event a rejection is made, it is a best practice for the examiner to consult the specification to determine if there are elements that could be added to the claim to make it eligible. If so, the examiner should identify those elements in the Office action and suggest them as a way to overcome the rejection.

III.    EVIDENTIARY REQUIREMENTS IN MAKING A § 101 REJECTION

The courts consider the determination of whether a claim is eligible (which involves identifying whether an exception such as an abstract idea is being claimed) to be a question of law. Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1047, 119 USPQ2d 1370, 1372 (Fed. Cir. 2016); OIP Techs. v. Amazon.com, 788 F.3d 1359, 1362, 115 USPQ2d 1090, 1092 (Fed. Cir. 2015); DDR Holdings v. Hotels.com, 773 F.3d 1245, 1255, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014); In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335, 110 USPQ2d 1668, 1670 (Fed. Cir. 2014); In re Bilski, 545 F.3d 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (en banc), aff’d by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010). Thus, the court does not require "evidence" that a claimed concept is a judicial exception, and generally decides the legal conclusion of eligibility without resolving any factual issues. FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1097, 120 USPQ2d 1293, 1298 (Fed. Cir. 2016) (citing Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1373, 118 USPQ2d 1541, 1544 (Fed. Cir. 2016)); OIP Techs., 788 F.3d at 1362, 115 USPQ2d at 1092; Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1349, 113 USPQ2d 1354, 1359 (Fed. Cir. 2014).

When determining whether claimed subject matter is judicially-excepted, the Federal Circuit typically compares the claimed subject matter to subject matter identified as an exception in its prior precedent. Amdocs (Israel) Ltd. v. Openet Telecom, Inc., 841 F.3d 1288, 1294, 120 USPQ2d 1527, 1532 (Fed. Cir. 2016) ("[T]he decisional mechanism courts now apply is to examine earlier cases in which a similar or parallel descriptive nature can be seen [and consider] what prior cases were about, and which way they were decided.") (citation omitted). The court has followed the same approach when reviewing the correctness of the Office’s conclusions that particular claims were directed to abstract ideas. See, e.g., In re Smith, 815 F.3d 816, 818-19, 118 USPQ2d 1245, 1247 (Fed. Cir. 2016) (review of a rejection under 35 U.S.C. 101 in an ex parte appeal); Apple, Inc. v. Ameranth, Inc., 842 F.3d 1229, 1241, 120 USPQ2d 1844, 1854 (Fed. Cir. 2016) (review of a Board determination of unpatentability under 35 U.S.C. 101 in a Covered Business Method review) and Versata Development Group v. SAP America, Inc., 793 F.3d 1306, 1333-34, 115 USPQ2d 1681, 1700-01 (Fed. Cir. 2015) (review of a Board determination of unpatentability under 35 U.S.C. 101 in a Covered Business Method review).

Similarly, the courts do not require any evidence when conducting the significantly more inquiry, even where additional elements were identified as well-understood, routine and conventional in the art. See, e.g., Alice Corp., 134 S. Ct. at 2359-60, 110 USPQ2d at 1984-85 (citing prior Supreme Court decisions in support of identifying additional elements as "purely conventional" basic computing functions, and thus well-understood, routine, conventional activity); Smith, 815 F.3d at 819, 118 USPQ2d at 1247 (identifying the steps of shuffling and dealing physical playing cards as "purely conventional" activities, and thus well-understood, routine, conventional activity).

When performing the analysis at Step 2A, it is sufficient for the examiner to provide a reasoned rationale that identifies the judicial exception recited in the claim and explains why it is considered a judicial exception. Therefore, there is no requirement for the examiner to rely on evidence, such as publications, to find that a claim is directed to a judicial exception. Cf. Affinity Labs of Tex., LLC v. Amazon.com Inc., 838 F.3d 1266, 1271-72, 120 USPQ2d 1210, 1214-15 (Fed. Cir. 2016) (affirming district court decision that identified an abstract idea in the claims without relying on evidence); OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1362-64, 115 USPQ2d 1090, 1092-94 (Fed. Cir. 2015) (same); Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357-58 (Fed. Cir. 2014) (same).

Similarly, at Step 2B, there is no requirement for evidence to support a finding that the claim does not recite significantly more than the judicial exception (e.g., the additional limitations are well-understood, routine, conventional activities). However, if available, sources of evidence can be provided to support the assertion or, when appropriate, to rebut an argument or evidence from applicant. In situations where the specification identifies certain elements as conventional, that information can be used to provide a basis for asserting that certain additional limitations do not amount to significantly more when making a rejection. When addressing a rebuttal argument, for example, a manual or handbook showing conventional computer components or functions could be used to refute an argument that using a certain additional computer element is not routine. Another source could be a patent that illustrates the state of the art, such as a background discussion of conventional components or actions routinely taken. The evidence would not be used to show a lack of novelty, which is not part of the Step 2B inquiry, but rather to show the state of the art. Another source of evidence is a court decision. As one example, the court in Content Extraction noted that use of a scanner to extract data from a document was well-known at the time of filing. 776 F.3d at 1348, 113 USPQ2d at 1358. As another example, Versata described the steps of arranging, storing, retrieving, sorting, eliminating, and determining information with a computer as "normal, basic functions of a computer." 793 F.3d at 1335, 115 USPQ2d at 1702. Care should be taken to ensure that the facts of any case law cited in support of a finding of conventionality comport with the facts of the application being examined. In other words, the examiner should be familiar with the facts of the case law before citing it for support in an Office action.