On October 17, 2019, the United States Patent and Trademark Office (USPTO) released an update to its 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) previously published on January 7, 2019. The October 2019 Update responds to the numerous public comments received by the USPTO to the 2019 PEG, broken down into five major themes:
(I) evaluating whether a claim recites a judicial exception,
(II) the groupings of abstract ideas enumerated in the 2019 PEG,
(III) evaluating whether a judicial exception is integrated into a practical application,
(IV) the prima facie case and the role of evidence with respect to eligibility rejections, and
(V) the application of the 2019 PEG in the patent examining corps.
Of interest to practitioners, the update provides new Life Sciences and Data Processing Examples 43-46 that are illustrative of the application of 35 U.S.C. Section 101 with respect to patent eligibility. These new examples, which add to the body of 42 examples the USPTO previously issued, describe the application of Revised Step 2A to product claims directed to a machine or manufacture (a controller), product claims reciting nature-based product limitations, method claims regarding identification data, and treatment claims. Some of these new examples also describe how certain claims are analyzed for patent eligibility under Step 2B.
Life Science Examples 43 and 44
By way of the October 2019 Update, the USPTO updates its guidance to reflect the Federal Circuit’s recent decisions in Vanda Pharms. Inc. v. West-Ward Pharms. Int’l Ltd., 887 F.3d 1117 (Fed. Cir. 2018) and Endo Pharms. Inc. v. Teva Pharms. USA Inc., 919 F.3d 1347 (Fed. Cir. 2019), in which methods of treatment were found patent eligible, even though the methods leveraged a judicial exception as part of an initial diagnostic step to identify patients suitable for the recited treatment.
Although the USPTO previously released a Memorandum in June 2018, in response to Vanda (“(1) ‘method of treatment’ claims that practically apply natural relationships should be considered patent eligible under Step 2A of the USPTO’s subject matter eligibility guidance; and (2) it is not necessary for ‘method of treatment’ claims that practically apply natural relationships to include non-routine or unconventional steps to be considered patent eligible under 35 U.S.C. § 101”), the USPTO has not opined, until now, as to the level of specificity required in the treatment step.
In the October 2019 Update, the USPTO explains that the treatment (or prophylaxis) limitation must be “particular.” For instance, for a process using a judicial exception to “identify if a patient has a genotype associated with poor metabolism of beta blocker medications,” the October 2019 Update explains that the subsequent step of “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype” is sufficiently “particular.” In contrast, the generic step of merely “administering a suitable medication to a patient” is not found to be sufficiently “particular.”
Additionally, the October 2019 Update explains that a treatment (or prophylaxis) step may be “particular,” yet still fail to confer patent eligibility: if the treatment (or prophylaxis) lacks a sufficient relationship to the exception. For instance, the October 2019 Update explains, for a process that “recites a natural correlation … between blood glucose levels over 250 mg/dl and the risk of developing ketoacidosis,” treating with insulin has a sufficient relationship to the exception (because insulin controls blood glucose). In contrast, treating with aspirin is found to have no more than “a nominal or insignificant relationship” to the judicial exception (because aspirin is not known to control blood glucose).
Example 43 in Appendix 1 to the October 2019 Update is informative in these respects.
Ineligible Claim 1 in Example 43 recites “a treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype; [and] (b) administering a treatment to the patient having a non-responder phenotype.” In the USPTO’s view, although Claim 1 recites a treatment step per se, it is not sufficiently particular (“it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into account when deciding which treatment to administer …”).
Eligible Claim 2 in Example 43 (“[t]he method of claim 1, wherein the treatment is a non-steroidal agent capable of treating NAS-3”), by contrast, signals that so long as there is some meaningful relationship between the judicial exception, and the treatment administered to the patient, the treatment step need not be especially specific. In Claim 2, for example, any “agent capable of treating NAS-3” is encompassed, so long as the agent is a “non-steroidal” agent. The “practice note” accompanying Claim 2, however, cautions that such a generic treatment step – although sufficient to confer eligibility – may trigger other patentability issues, such as a lack of written description (for the entire genus of non-steroidal treatment agents). Claims 3 and 4 in Example 43 recite particular, known, treatments (“rapamycin” and “a course of plasmapheresis”), and predictably, are also indicated as eligible.
Example 44, also a life-science example, relates to product claims. Of interest in this example is Claim 4, which recites “[a] dosage unit [comprising denveric acid in a container, and] further comprising protamine that is mixed with the denveric acid in the container in an amount of 0.75 mg to 1.5 mg protamine per every mg of denveric acid.” This claim is found to be eligible – even though denveric acid and protamine are stated to naturally occur, albeit separately – because “this mixture … has particular glycemic control characteristics … [that] are different than the mere ‘sum’ of the glycemic control characteristics of the individual components.” That is, when this combination product is used in a particular context, i.e., injected into an individual to control blood sugar, the mixture exhibits different functional properties (“denveric acid by itself has relatively short-acting glycemic control characteristics … and the protamine by itself has no glycemic control characteristic, but when combined in the claimed ratio, the resultant mixture has intermediate glycemic control characteristics”).
This is analogous to the situation where unexpected synergy (of a combination product), observed in a particular use, can impart non-obviousness to the combination product per se (and not just to a method directed to that particular use). See In re Papesch, 315 F.2d 381 (C.C.P.A. 1963).
Data Processing Examples 45 and 46
By way of Data Processing Example 45 in the Appendix 1 to the October 2019 Update, the USPTO updates its guidance to reflect how a controller claim may be patent eligible under Step 2B based on the Federal Circuit’s decision in Berkheimer v. HP Inc., 881F.3d1360 (Fed. Cir. 2018), which holds that evidence is required to support an assertion that additional elements are “well-understood, routine, conventional activity.”
Although the USPTO previously released a Memorandum in April 2018, in response to Berkheimer (addressing the factual issue of “whether an additional element (or combination of additional elements) represents well-understood, routine, conventional activity” to be considered not patent eligible under 35 U.S.C. § 101), the USPTO has not opined, until now, on how a claim may overcome the Step 2B. None of the January 2019 Examples 37-42 illustrated an example of how a data processing claim may overcome Step 2B.
In claim 3 of Example 45 of the October 2019 Update, the USPTO explains that the step of repeatedly measuring by an ARCXY thermocouple (made from alloys ARC and XY) for molding control, renders claim 3 patent eligible under Step 2B. Despite evidence that NASA had performed repeated measurements using an ARXCY thermocouple, the rejection had not established repeatedly measuring with an ARCXY thermocouple for molding control. In this regard, page 26 of the October 2019 Update states:
the only reference the examiner has found that discloses this type of thermocouple is a journal article written by several scientists employed by the National Aeronautics and Space Administration, which describes the use of an ARCXY thermocouple to measure temperatures repeatedly in conjunction with spacecraft and landing vehicles used for atmospheric studies on other planets where particularly robust equipment is required. Accordingly, the examiner determines that while ARCXY thermocouples are known, mere knowledge of this type of thermocouple in the aeronautical industry does not make its use in an injection molding apparatus routine or conventional.
Example 45 also illustrates application of the Step 2A to product claims reciting a controller for controlling the injection molding of a hypothetical chemical (polyurethane polymer X46). Claim 1 of Example 45, which repeatedly obtains temperature measurements of a mold, and performs a calculation and determination, is not patent eligible because the claim is directed to an abstract idea, and the claim as a whole does not integrate the abstract idea into a practical application (“[t]he controller is also an additional element which is configured to carry out limitations (a), (b) and (c), i.e., it is the tool that is used to obtain the temperature measurements and perform the mathematical calculations and numeric conversions. But the controller is recited so generically (no details whatsoever are provided other than that it is a ‘controller’) that it represents no more than mere instructions to apply the judicial exceptions on a computer”) or amount to significantly more than the abstract idea. However, Claim 2, which adds limitations of controlling signals for opening the mold and ejecting from the mold based on a target percentage being reached, is eligible because it recites these limitations that improve the previous molding technology, such that the claim integrates the abstract idea into a practical application. Claim 3, which was discussed above, recites the same abstract as claims 1 and 2, and lacks any additional elements that integrate the exceptions into a practical application, but nonetheless is eligible in Step 2B because it recites a specific and unconventional tool (i.e., repeatedly measuring by an ARCXY thermocouple for molding control) in the data gathering steps that amounts to significantly more than the abstract idea.
In addition, Example 46 in Appendix 1 to the October 2019 is further informative with respect to eligibility of data processing related to health monitoring.
Example 46 “illustrates the application of Revised Step 2A to claims for obtaining and analyzing identification and behavioral data of livestock animals, such as dairy cattle. Grass tetany (also called grass staggers) is a real nutritional deficiency that affects ruminant animals such as cattle and sheep.”
Claim 1 in Example 46 is ineligible because the data gathering could reasonably be performed in the mind (abstract idea: mental concept), and the additional elements of a livestock interface and the monitoring component are extra-solution activity that do not amount to a practical application. In this regard, the Update states “the monitoring component in the processor performs the necessary software tasks so that the result of the abstract mental process is displayed on the display. This limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim." That is, "Claim 1 is ineligible because it recites a judicial exception (an abstract idea), and the claim as a whole does not integrate the exception into a practical application or amount to significantly more than the exceptions.”
On the other hand, Claim 2 is eligible “because it recites other meaningful limitations, which, when evaluated in combination, integrate the exceptions into a practical application.” In particular, Claim 2 includes “a feed dispenser … [that] dispense[s] individualized amounts of feed and optional supplements” and the monitoring includes “automatically sending a control signal to the feed dispenser to dispense a therapeutically effective amount … when … the animal is exhibiting an aberrant behavioral pattern indicative of grass tetany.” Thus, “limitation (d) does not merely link the judicial exceptions to a technical field, but instead adds a meaningful limitation in that it can employ the information provided by the judicial exception (the mental analysis of whether the animal is exhibiting an aberrant behavioral pattern indicative of grass tetany) to operate the feed dispenser. As explained in the specification, automatically identifying aberrant behavioral patterns and operating farm equipment based on such identification avoids the need for the farmer to evaluate the behavior of each animal in the herd on a continual basis.”
Claim 3 of Example 46 follows the same or a similar approach.
Claim 4 of Example 46 does not even recite an abstract idea and thus is patent eligible under a Step 2A Prong One analysis. Claim 4 of Example 46 recites a memory, a processor and a herd monitor. The instructions for the processor include “a livestock interface for obtaining animal-specific information for a plurality of animals in the herd, wherein the animal-specific information comprises animal identification data and at least one of body position data, body temperature data, feeding behavior data, and movement pattern data, “ and the herd monitor includes “(a) a radio frequency reader for collecting the animal-specific information from a plurality of animal sensors attached to the animals in the herd when the animal sensors are within proximity to the radio frequency reader, each animal sensor having a radio frequency transponder, and (b) a transmitter for transmitting the collected animal-specific information to the livestock interface.” However, none of the claim elements recite a judicial exception (“[b]ecause the claim does not recite a judicial exception, it cannot be directed to one (Step 2A: NO). The claim is eligible”).
Contributors: Alan C. Townsley, Ph.D. and John P. Hocker
Editors: Raja N. Saliba and Chris J. Bezak