2106.07(a) Formulating a Rejection For Lack of Subject Matter Eligibility [R-10.2019]

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 § 2106.03.

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

  • • For Step 2A Prong One, 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 is 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 2A Prong Two, the rejection should identify any additional elements (specifically point to claim features/limitations/steps) recited in the claim beyond the identified judicial exception; and evaluate the integration of the judicial exception into a practical application by explaining that 1) there are no additional elements in the claim; or 2) the claim as a whole, looking at the additional elements individually and in combination, does not integrate the judicial exception into a practical application using the considerations set forth in MPEP §§ 2106.04(d), 2106.05(a)(c) and (e)(h). Examiners should give weight to all of the claimed additional elements in Prong Two, even if those elements represent well-understood, routine, conventional activity.
  • • For Step 2B, the rejection should explain why the additional elements, taken individually and in combination, do not result in the claim, as a whole, amounting to significantly more than the identified judicial exception. For instance, when the examiner has concluded that certain claim elements recite well understood, routine, conventional activities in the relevant field, the examiner must expressly support the rejection in writing with one of the four options specified in Subsection III.

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 PRONG ONE)

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 explain why those claim limitations set forth or describe a judicial exception (e.g., a law of nature). 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 falls within one of the groupings of abstract ideas (i.e., mathematical concepts, mental processes, or certain methods of organizing human activity) enumerated in MPEP § 2106.04(a)(2). Alternatively, the examiner should provide justification for why a specific limitation(s) recited in the claim is being treated as an abstract idea if it does not fall within the groupings of abstract ideas in accordance with the “tentative abstract idea” procedure (see MPEP § 2106.04, subsection (IV)). While not required, this explanation or justification may include citing to an appropriate court decision that supports the identification of the subject matter recited in the claim language as an abstract idea within one of the groupings. 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 enumerated as abstract ideas in MPEP § 2106.04, unless they are identifying a tentative abstract idea in the claim, 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/ PatentEligibility).

Sample explanation: The claim recites the step of comparing collected information to a predefined threshold, which is an act of evaluating information that can be practically performed in the human mind. Thus, this step is an abstract idea in the “mental process” grouping.

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 INTEGRATING THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION OR AMOUNTING TO SIGNIFICANTLY MORE THAN THE JUDICIAL EXCEPTION (STEP 2A PRONG TWO AND 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 integrate the judicial exception into a practical application and 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 integrate an exception into a practical application or 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 2A Prong Two inquiry and Step 2B inquiry that the additional elements do not integrate the exception into a practical application and 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 integrate an exception into a practical application or provide an inventive concept by adding a meaningful limitation to the claimed exception. See MPEP §§ 2106.04(d) and 2106.05 for a listing of considerations that qualify, and to not qualify, as integrating an exception or providing significantly more than an exception , and MPEP § 2106.07(c) for more information on clarifying the record when a claim is found eligible.

In the Step 2B inquiry, if 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 support this conclusion in writing with a factual determination in accordance with Subsection III below. See MPEP § 2106.05(d) for more information about well understood, routine, conventional activities and elements, and Subsection III below for more information about how to support a conclusion that a claim limitation is well understood, routine, conventional activity.

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. 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(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, and MPEP § 2106.05(d) for more information about well understood, routine, conventional activities and elements (a relevant consideration only in Step 2B).

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 should 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 integrate the exception into a practical application or add significantly more, similar to how limiting the computer implemented abstract idea in Flook to petrochemical and oil-refining industries was insufficient. See e.g., 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). In some cases, however, the courts have characterized the issue of whether additional elements are well-understood, routine, conventional activity as an underlying factual issue upon which the legal conclusion of eligibility may be based. See, e.g., Interval Licensing LLC v. AOL, Inc., 896 F.3d. 1335, 1342, 127 USPQ2d 1553, 1557 (Fed. Cir. 2018) (patent eligibility is a question of law that may contain underlying issues of fact), Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018) (issue of whether additional elements are well-understood, routine, conventional activity is factual).

When performing the analysis at Step 2A Prong One, 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 (e.g., that the claim limitation(s) falls within one of the abstract idea groupings). Therefore, there is no requirement for the examiner to rely on evidence, such as publications or an affidavit or declaration under 37 CFR 1.104(d)(2), to find that a claim recites 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).

At Step 2A Prong Two or Step 2B, there is no requirement for evidence to support a finding that the exception is not integrated into a practical application or that the additional elements do not amount to significantly more than the exception unless the examiner asserts that additional limitations are well-understood, routine, conventional activities in Step 2B.

Examiners should not assert that an additional element (or combination of elements) is well-understood, routine, or conventional unless the examiner finds, and expressly supports the rejection in writing with one or more of the following:

  • (A) A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s). A specification demonstrates the well-understood, routine, conventional nature of additional elements when it describes the additional elements as well-understood or routine or conventional (or an equivalent term), as a commercially available product, or in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a). A finding that an element is well-understood, routine, or conventional cannot be based only on the fact that the specification is silent with respect to describing such element.
  • (B) A citation to one or more of the court decisions discussed in MPEP § 2106.05(d), subsection II, as noting the well-understood, routine, conventional nature of the additional element(s). Examiners should be careful to ensure the claim limitations before the examiner are the same as those found to be well-understood, routine, conventional by the courts. The additional elements under examination should be recited in the same manner, meaning they should be recited at the same high level of generality as in those court decisions. It is not enough that the additional elements are similar to the elements at issue in those cases. In addition, the court decisions discussed in MPEP § 2106.05(d), subsection II, are 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(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.
  • (C) A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s). An appropriate publication could include a book, manual, review article, or other source that describes the state of the art and discusses what is well-known and in common use in the relevant industry. It does not include all items that might otherwise qualify as a “printed publication” as used in 35 U.S.C. 102. Whether something is disclosed in a document that is considered a “printed publication” under 35 U.S.C. 102 is a distinct inquiry from whether something is well-known, routine, conventional activity. A document may be a printed publication but still fail to establish that something it describes is well-understood, routine, conventional activity. See Exergen Corp. v. Kaz USA, 725 Fed. App’x. at 959, 966 (Fed. Cir. 2018) (the single copy of a thesis, written in German and located in a German university library, considered to be a “printed publication” in In re Hall, 781 F.2d 897, 228 USPQ 453 (Fed. Cir. 1986) “would not suffice to establish that something is ‘well-understood, routine, and conventional activity previously engaged in by scientists who work in the field'”). The nature of the publication and the description of the additional elements in the publication would need to demonstrate that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a). For example, while U.S. patents and published applications are publications, merely finding the additional element in a single patent or published application would not be sufficient to demonstrate that the additional element is well-understood, routine, conventional, unless the patent or published application demonstrates that the additional element is widely prevalent or in common use in the relevant field.
  • (D) A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). This option should be used only when examiners are certain, based upon their personal knowledge, that the additional element(s) represents well-understood, routine, conventional activity engaged in by those in the relevant art, in that the additional elements are widely prevalent or in common use in the relevant field, comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a). For example, the examiner could take official notice that a generic computer component performing generic computer functions at a high level of generality, such as using the Internet to gather data, is well-understood, routine, conventional. Procedures for taking official notice and addressing an applicant’s challenge to official notice are discussed in MPEP § 2144.03.