2106.04(d)    Integration of a Judicial Exception Into A Practical Application [R-10.2019]

The Supreme Court has long distinguished between principles themselves (which are not patent eligible) and the integration of those principles into practical applications (which are patent eligible). See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in Diamond v. Diehr found ‘‘the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,’’ but the Court in Gottschalk v. Benson ‘‘held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle’’). Similarly, in a growing body of decisions, the Federal Circuit has distinguished between claims that are ‘‘directed to’’ a judicial exception (which require further analysis to determine their eligibility) and those that are not (which are therefore patent eligible), e.g., claims that improve the functioning of a computer or other technology or technological field. See Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972). See, e.g., MPEP § 2106.06(b) (summarizing Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016), McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 120 USPQ2d 1091 (Fed. Cir. 2016), and other cases that were eligible as improvements to technology or computer functionality instead of being directed to abstract ideas).

Accordingly, after determining that a claim recites a judicial exception in Step 2A Prong One, examiners should evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception in Step 2A Prong Two. A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. Whether or not a claim integrates a judicial exception into a practical application is evaluated using the considerations set forth in subsection I below, in accordance with the procedure described below in subsection II.

In the context of the flowchart in MPEP § 2106, subsection III, Step 2A Prong Two determines whether:

  • • The claim as a whole integrates the judicial exception into a practical application, in which case the claim is not directed to a judicial exception (Step 2A: NO) and is eligible at Pathway B. This concludes the eligibility analysis.
  • • The claim as a whole does not integrate the exception into a practical application, in which case the claim is directed to the judicial exception (Step 2A: YES), and requires further analysis under Step 2B (where it may still be eligible if it amounts to an inventive concept). See MPEP § 2106.05 for discussion of Step 2B.

I.    RELEVANT CONSIDERATIONS FOR EVALUATING WHETHER ADDITIONAL ELEMENTS INTEGRATE A JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION

The Supreme Court and Federal Circuit have identified a number of considerations as relevant to the evaluation of whether the claimed additional elements demonstrate that a claim is directed to patent-eligible subject matter. The list of considerations here is not intended to be exclusive or limiting. Additional elements can often be analyzed based on more than one type of consideration and the type of consideration is of no import to the eligibility analysis. Additional discussion of these considerations, and how they were applied in particular judicial decisions, is provided in MPEP § 2106.05(a) through (c) and MPEP § 2106.05(e) through (h).

Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:

  • • An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
  • • Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
  • • Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
  • • Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
  • • Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).

The courts have also identified limitations that did not integrate a judicial exception into a practical application:

  • • Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
  • • Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
  • • Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).

Step 2A Prong Two is similar to Step 2B in that both analyses involve evaluating a set of judicial considerations to determine if the claim is eligible. See MPEP §§ 2106.05(a) through (h) for the list of considerations that are evaluated at Step 2B. Although most of these considerations overlap (i.e., they are evaluated in both Step 2A Prong Two and Step 2B), Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, conventional activity. Accordingly, in Step 2A Prong Two, examiners should ensure that they give weight to all additional elements, whether or not they are conventional, when evaluating whether a judicial exception has been integrated into a practical application. Additional elements that represent well-understood, routine, conventional activity may integrate a recited judicial exception into a practical application.

It is notable that mere physicality or tangibility of an additional element or elements is not a relevant consideration in Step 2A Prong Two. As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USPQ2d 1976, 1983-84 (2014) ("The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point"). See also Genetic Technologies Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1547 (Fed. Cir. 2016) (steps of DNA amplification and analysis are not "sufficient" to render claim 1 patent eligible merely because they are physical steps). Conversely, the presence of a non-physical or intangible additional element does not doom the claims, because tangibility is not necessary for eligibility under the Alice/Mayo test. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 118 USPQ2d 1684 (Fed. Cir. 2016) ("that the improvement is not defined by reference to ‘physical’ components does not doom the claims"). See also McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102 (Fed. Cir. 2016), (holding that a process producing an intangible result (a sequence of synchronized, animated characters) was eligible because it improved an existing technological process).

In addition, a specific way of achieving a result is not a stand-alone consideration in Step 2A Prong Two. However, the specificity of the claim limitations is relevant to the evaluation of several considerations including the use of a particular machine, particular transformation and whether the limitations are mere instructions to apply an exception. See MPEP §§ 2106.05(b), 2106.05(c), and 2106.05(f). For example, in Parker v. Flook, 437 U.S. 584, 198 USPQ 193 (1978), the Supreme Court noted that the "patent application does not purport to explain how to select the appropriate margin of safety, the weighting factor, or any of the other variables" in the claimed mathematical formula, "[n]or does it purport to contain any disclosure relating to the chemical processes at work, the monitoring of process variables, or the means of setting off an alarm or adjusting an alarm system." 437 U.S. at 586, 198 USPQ at 195. The Court found this failure to explain any specifics of how to use the claimed formula informative when deciding that the additional elements in the claim were insignificant post-solution activity and thus not meaningful enough to render the claim eligible. 437 U.S. at 589-90, 198 USPQ at 197.

II.    HOW TO EVALUATE WHETHER THE ADDITIONAL ELEMENTS INTEGRATE THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION

The analysis under Step 2A Prong Two is the same for all claims reciting a judicial exception, whether the exception is an abstract idea, a law of nature, or a natural phenomenon (including products of nature). Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).

Many of these considerations overlap, and often more than one consideration is relevant to analysis of an additional element. Not all considerations will be relevant to every element, or every claim. Because the evaluation in Prong Two is not a weighing test, it is not important how the elements are characterized or how many considerations apply from the list. It is important to evaluate the significance of the additional elements relative to applicant’s invention, and to keep in mind the ultimate question of whether the exception is integrated into a practical application. If the claim as a whole integrates the judicial exception into a practical application based upon evaluation of these considerations, the additional limitations impose a meaningful limit on the judicial exception and the claim is eligible at Step 2A.

Examiners should examine each claim for eligibility separately, based on the particular elements recited therein. Claims should not be judged to automatically stand or fall with similar claims in an application. For instance, one claim may be ineligible because it is directed to a judicial exception without amounting to significantly more, but another claim dependent on the first may be eligible because it recites additional elements that do amount to significantly more, or that integrate the exception into a practical application.

For more information on how to evaluate claims reciting multiple judicial exceptions, see MPEP § 2106.04, subsection II.B.

III.    EXAMPLES OF HOW THE OFFICE EVALUATES WHETHER THE CLAIM AS A WHOLE INTEGRATES THE JUDICIAL EXCEPTION INTO A PRACTICAL APPLICATION

The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application. Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. However, the way in which the additional elements use or interact with the exception may integrate it into a practical application. Accordingly, the additional limitations should not be evaluated in a vacuum, completely separate from the recited judicial exception. Instead, the analysis should take into consideration all the claim limitations and how those limitations interact and impact each other when evaluating whether the exception is integrated into a practical application.

Two examples of how the Office evaluates whether the claim as a whole integrates the recited judicial exception into a practical application are provided. In Solutran, Inc. v. Elavon, Inc., 931 F.3d 1161, 2019 USPQ2d 281076 (Fed. Cir. 2019), the claims were to methods for electronically processing paper checks, all of which contained limitations setting forth receiving merchant transaction data from a merchant, crediting a merchant’s account, and receiving and scanning paper checks after the merchant’s account is credited. In part one of the Alice/Mayo test, the Federal Circuit determined that the claims were directed to the abstract idea of crediting the merchant’s account before the paper check is scanned. The court first determined that the recited limitations of "crediting a merchant’s account as early as possible while electronically processing a check" is a "long-standing commercial practice" like in Alice and Bilski. 931 F.3d at 1167, 2019 USPQ2d 281076, at *5 (Fed. Cir. 2019). The Federal Circuit then continued with its analysis under part one of the Alice/Mayo test finding that the claims are not directed to an improvement in the functioning of a computer or an improvement to another technology. In particular, the court determined that the claims "did not improve the technical capture of information from a check to create a digital file or the technical step of electronically crediting a bank account" nor did the claims "improve how a check is scanned." Id. This analysis is equivalent to the Office’s analysis of determining that the exception is not integrated into a practical application at Step 2A Prong Two, and thus that the claims are directed to the judicial exception (Step 2A: YES).

In Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018), the claimed invention was a method of virus scanning that scans an application program, generates a security profile identifying any potentially suspicious code in the program, and links the security profile to the application program. 879 F.3d at 1303-04, 125 USPQ2d at 1285-86. The Federal Circuit noted that the recited virus screening was an abstract idea, and that merely performing virus screening on a computer does not render the claim eligible. 879 F.3d at 1304, 125 USPQ2d at 1286. The court then continued with its analysis under part one of the Alice/Mayo test by reviewing the patent’s specification, which described the claimed security profile as identifying both hostile and potentially hostile operations. The court noted that the security profile thus enables the invention to protect the user against both previously unknown viruses and "obfuscated code," as compared to traditional virus scanning, which only recognized the presence of previously-identified viruses. The security profile also enables more flexible virus filtering and greater user customization. 879 F.3d at 1304, 125 USPQ2d at 1286. The court identified these benefits as improving computer functionality, and verified that the claims recite additional elements (e.g., specific steps of using the security profile in a particular way) that reflect this improvement. Accordingly, the court held the claims eligible as not being directed to the recited abstract idea. 879 F.3d at 1304-05, 125 USPQ2d at 1286-87. This analysis is equivalent to the Office’s analysis of determining that the additional elements integrate the judicial exception into a practical application at Step 2A Prong Two, and thus that the claims were not directed to the judicial exception (Step 2A: NO).

2106.04(d)(1)    Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in Step 2A Prong Two [R-10.2019]

A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional elements demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the claimed invention improves the functioning of a computer or improves another technology or technical field. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A because they are not "directed to" the recited judicial exception.

The courts have not provided an explicit test for this consideration, but have instead illustrated how it is evaluated in numerous decisions. These decisions, and a detailed explanation of how examiners should evaluate this consideration are provided in MPEP § 2106.05(a). In short, first the specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. Second, if the specification sets forth an improvement in technology, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement. That is, the claim includes the components or steps of the invention that provide the improvement described in the specification. The claim itself does not need to explicitly recite the improvement described in the specification (e.g., "thereby increasing the bandwidth of the channel").

While the courts usually evaluate "improvements" as part of the "directed to" inquiry in part one of the Alice/Mayo test (equivalent to Step 2A), they have also performed this evaluation in part two of the Alice/Mayo test (equivalent to Step 2B). See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349-50, 119 USPQ2d 1236, 1241-42 (Fed. Cir. 2016). However, the improvement analysis at Step 2A Prong Two differs in some respects from the improvements analysis at Step 2B. Specifically, the "improvements" analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity. That is, the claimed invention may integrate the judicial exception into a practical application by demonstrating that it improves the relevant existing technology although it may not be an improvement over well-understood, routine, conventional activity. It should be noted that while this consideration is often referred to in an abbreviated manner as the "improvements consideration," the word "improvements" in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.

Examples of claims that improve technology and are not directed to a judicial exception include: Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1339, 118 USPQ2d 1684, 1691-92 (Fed. Cir. 2016) (claims to a self-referential table for a computer database were directed to an improvement in computer capabilities and not directed to an abstract idea); McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1315, 120 USPQ2d 1091, 1102-03 (Fed. Cir. 2016) (claims to automatic lip synchronization and facial expression animation were directed to an improvement in computer-related technology and not directed to an abstract idea); Visual Memory LLC v. NVIDIA Corp., 867 F.3d 1253,1259-60, 123 USPQ2d 1712, 1717 (Fed. Cir. 2017) (claims to an enhanced computer memory system were directed to an improvement in computer capabilities and not an abstract idea); Finjan Inc. v. Blue Coat Systems, Inc., 879 F.3d 1299, 125 USPQ2d 1282 (Fed. Cir. 2018) (claims to virus scanning were found to be an improvement in computer technology and not directed to an abstract idea); SRI Int’l, Inc. v. Cisco Systems, Inc., 930 F.3d 1295, 1303 (Fed. Cir. 2019) (claims to detecting suspicious activity by using network monitors and analyzing network packets were found to be an improvement in computer network technology and not directed to an abstract idea). Additional examples are provided in MPEP § 2106.05(a).

2106.04(d)(2)    Particular Treatment and Prophylaxis in Step 2A Prong Two

A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional element(s) demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. Such claims are eligible at Step 2A, because they are not "directed to" the recited judicial exception.

The particular treatment or prophylaxis consideration originated as part of the other meaningful limitations consideration discussed in MPEP § 2106.05(e) and shares the same legal basis in Supreme Court jurisprudence as that consideration. However, recent jurisprudence has provided additional guidance that is especially relevant to only a subset of claims, thus warranting the elevation of the particular treatment or prophylaxis consideration to become a stand-alone consideration in the Step 2A Prong Two analysis. Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). The claims in Vanda recited a method of treating a patient having schizophrenia with iloperidone, a drug known to cause QTc prolongation (a disruption of the heart’s normal rhythm that can lead to serious health problems) in patients having a particular genotype associated with poor drug metabolism. 887 F.3d at 1121, 126 USPQ2d at 1269-70. In particular, the claims recited steps of: (1) performing a genotyping assay to determine if a patient has a genotype associated with poor drug metabolism; and (2) administering iloperidone to the patient in a dose range that depends on the patient’s genotype. Id. Although Vanda’s claims recited a law of nature (the naturally occurring relationship between the patient’s genotype and the risk of QTc prolongation) like the claims in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 101 USPQ2d 1961 (2012), the Federal Circuit distinguished them from the Mayo claims based on the differences in the administration steps. In particular, the court explained that Mayo’s step of administering a drug to a patient was performed in order to gather data about the recited laws of nature, and this step was thus ancillary to the overall diagnostic focus of the claims. 887 F.3d at 1134-35, 126 USPQ2d at 1280. In contrast, Vanda’s claims used the recited law of nature to more safely treat the patients with the drug, thereby reducing the patient’s risk of QTc prolongation. 887 F.3d at 1135, 126 USPQ2d at 1280. Accordingly, the court held Vanda’s claims eligible at the first part of the Alice/Mayo test (Step 2A) because the claims were not "directed to" the recited judicial exception. 887 F.3d at 1136, 126 USPQ2d at 1281.

Examples of "treatment" and prophylaxis" limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. For example, an immunization step that integrates an abstract idea into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases is considered to be a particular prophylaxis limitation that practically applies the abstract idea. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011).

Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.

When determining whether a claim applies or uses a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, the following factors are relevant.

  • a. The Particularity Or Generality Of The Treatment Or Prophylaxis
  • The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.

    Examiners may find it helpful to evaluate other considerations such as the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether a treatment or prophylaxis limitation is particular or general.

  • b. Whether The Limitation(s) Have More Than A Nominal Or Insignificant Relationship To The Exception(s)
  • The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). For example, consider a claim that recites a natural correlation (law of nature) between blood glucose levels over 250 mg/dl and the risk of developing ketoacidosis (a life-threatening medical condition). The claim also recites "treating a patient having a blood glucose level over 250 mg/dl with insulin". Insulin acts to lower blood glucose levels, and administering insulin to a patient will reduce the patient’s blood glucose level, thereby lowering the risk that the patient will develop ketoacidosis. Thus, in the context of this claim, the administration step is significantly related to the recited correlation between high blood glucose levels and the risk of ketoacidosis. Because insulin is also a "particular" treatment, this administration step integrates the law of nature into a practical application. Alternatively, consider a claim that recites the same law of nature and also recites "treating a patient having a blood glucose level over 250 mg/dl with aspirin." Aspirin is not known in the art as a treatment for ketoacidosis or diabetes, although some patients with diabetes may be on aspirin therapy for other medical reasons (e.g., to control pain or inflammation, or to prevent blood clots). In the context of this claim and the recited correlation between high blood glucose levels and the risk of ketoacidosis, administration of aspirin has at best a nominal connection to the law of nature, because aspirin does not treat or prevent ketoacidosis. This step therefore does not apply or use the exception in any meaningful way. Thus, this step of administering aspirin does not integrate the law of nature into a practical application.

    Examiners may find it helpful to evaluate other considerations such as the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)), and the field of use and technological environment consideration (see MPEP § 2106.05(h)), when making a determination of whether a treatment or prophylaxis limitation has more than a nominal or insignificant relationship to the exception(s).

  • c. Whether The Limitation(s) Are Merely Extra-Solution Activity Or A Field Of Use
  • The treatment or prophylaxis limitation must impose meaningful limits on the judicial exception, and cannot be extra-solution activity or a field-of-use. For example, consider a claim that recites (a) administering rabies and feline leukemia vaccines to a first group of domestic cats in accordance with different vaccination schedules, and (b) analyzing information about the vaccination schedules and whether the cats later developed chronic immune-mediated disorders to determine a lowest-risk vaccination schedule. Step (b) falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). While step (a) administers vaccines to the cats, this administration is performed in order to gather data for the mental analysis step, and is a necessary precursor for all uses of the recited exception. It is thus extra-solution activity, and does not integrate the judicial exception into a practical application. Conversely, consider a claim reciting the same steps (a) and (b), but also reciting step (c) "vaccinating a second group of domestic cats in accordance with the lowest-risk vaccination schedule." Step (c) applies the exception, in that the information from the mental analysis in step (b) is used to alter the order and timing of the vaccinations so that the second group of cats has a lower risk of developing chronic immune-mediated disorders. Step (c) thus integrates the abstract idea into a practical application.

    Examiners may find it helpful to evaluate other considerations such as the insignificant extra-solution activity consideration (see MPEP § 2106.05(g)), and the field of use and technological environment consideration (see MPEP § 2106.05(g)), when making a determination of whether a treatment or prophylaxis limitation is merely extra-solution activity or a field of use.