“In view of the continued denial of cases like Athena involving patent subject matter eligibility by the Supreme Court, patent practitioners and clients alike need to pay more attention to the issued USPTO guidance documents and relevant Federal Circuit case law.”
This article relates to key practice pointers for making a claim patent-eligible subject matter according to the U.S. Patent and Trademark Office’s (USPTO’s) October 2019 Patent Subject Matter Eligibility Guidance Update (October 2019 PEG Update).
The October 2019 PEG Update expands on the January 2019 PEG (Patent Subject Matter Eligibility Guidance). In view of the continued denial of cases involving patent subject matter eligibility, such as Athena Diagnostics, Inc. v. Mayo Collaborative Services, 915 F.3d 743 (Feb. 6, 2019) by the U.S. Supreme Court, patent practitioners and clients alike need to pay more attention to the issued guidance documents and relevant Federal Circuit case law. Accordingly, one needs to have strategies in place for dealing with compliance of patent claims with 35 U.S.C. § 101.
The steps of the Section 101 examination process, i.e., Step 1, Step 2A and Step 2B, can be summarized as follows:
- Step 1 asks whether the claim is to “a process, machine, manufacture or composition of matter” [Update on Section 101 Guidelines, May 9, 2019 at page 6]. The mere recitation of a judicial exception in a claim does not make that claim “directed” to that judicial exception.
- Step 2A generally asks whether the claim is directed to “a law of nature, a natural phenomenon (product of nature) or an abstract idea” [Id.] Step 2A is divided into two prongs.
- Prong One of Step 2A asks whether the claim “recites” an abstract idea, law of nature or natural phenomenon [Id.] If a claim satisfies Prong One of Step 2A, then further analysis under Prong Two of Step 2A needs to occur [Id.]
- Prong Two of Step 2A evaluates whether the claim recites additional elements that integrate the judicial exception into a practical application [Id.]
- If Prong Two of Step 2A is satisfied, i.e., a claim fails to recite additional elements that integrate the judicial exception into a practical application, one proceeds to Step 2B. Step 2B is the final step of the Section 101 examination process
- Step 2B asks whether the claim recites additional elements that amount to significantly more than the judicial exception [Id.] Based on such analysis, a final determination of whether a claim is patent-eligible under Section 101 can be made.
The focus of this article relates to (1) avoiding mental process claim rejections; and (2) making a claim patent-eligible by integrating the judicial exception into a practical application, with special considerations given to improvements in technology and medical treatment claims, as discussed below.
Avoiding Mental Process Claim Rejections
A claim limitation that recites a mental process is an example of an “abstract idea” claim limitation, which, by itself, is patent-ineligible under Section 101.
Patent practitioners and clients should be advised that claims “recite a mental process when they contain limitations that can practically be performed in the human mind, including, for example, observations, evaluations, judgments and opinions” [October 2019 PEG Update at page 7.] On the other hand, a claim to a specific data encryption method for computer communication involving a several-step manipulation of data cannot be practically performed in the mind and hence is patent-eligible under Section 101 [Id., citing Synopsys, Inc. v. Mentor Graphics Corp. (distinguishing the claims in TQP Development, LLC v. Intuit Inc.)].
Patent practitioners and clients should also be aware that claims, nevertheless, can still recite a mental process even where a claim recites use of a physical aid (e.g., a pen or paper) or performance of a mental step by a computer [Id. at pages 8-9]. In an example of unpatentable mental process, the October 2019 PEG Update pointed out a claim that recited the steps of voting, verifying the vote and submitting the vote for tabulation [Id. at page 8, citing Voter Verified, Inc. v. Election Systems & Software LLC.] Those steps constituted a patent-ineligible mental process because they could be performed in the human mind even though the steps were recited as being performed using a computer in the claim [Id. at pages 8-9].
Making a Claim Patent-Eligible by Integrating the Judicial Exception Into a Practical Application
- Improvements in Technology for Section 101 considerations
Significantly, the October 2019 PEG Update noted that the mere presence of a judicial exception under Prong One of Step 2A does not make the claim patent ineligible under Prong Two of Step 2A if that claim, as a whole, “integrates the recited judicial exception into a practical application of that exception” [Id. at page 10]. In that regard, additional claim limitations that reflect improvement in computer functioning or improvement to another technology or technical field integrate the recited judicial exception into a practical application; such limitations impose a meaningful limitation on the judicial exception, rendering a claim patent-eligible under Section 101 [Id. at page 11]. For example, a claim that recited a plurality of network monitors to analyze specific network traffic and integrating generated reports from the monitors to identify hackers and intruders on the network has claim features that demonstrated an improvement to computer network functioning [Id. at page 11].
Also, improvements in technology for Section 101 considerations also apply to life sciences inventions and any other technology. For example, the October 2019 PEG Update noted the Rapid Litigation Management Ltd. v. CellzDirect, Inc. case, where a new and improved way for preserving hepatocytes was deemed to be an improvement in technology even though the claim was based on natural discoveries [Id. at page 13]. This is good news for patent practitioners and clients alike. Accordingly, an improvement to any technology, irrespective of technical field, is a factor to consider in determining whether a claim as a whole integrates a judicial exception into a practical application under Prong Two of Step 2A.
Moreover, patent practitioners should make sure that the specification discloses improvements as recited in the claim, in view of the USPTO instructing evaluation of the specification by examiners in that regard [Id. at page 11]. Accordingly, patent practitioners can possibly avoid the need to provide rebuttal arguments and submitting additional evidence via a Rule 132 affidavit in a situation where the examiner raises an issue concerning whether the specification discloses the improvement [Id. at page 13].
- Avoiding rejections of medical treatment claims
For medical treatment claims, integration of a judicial exception into a practical application by applying or using the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition can be evaluated by the following three exemplary factors.
- Treatment/prophylaxis claim limitation should be “particular”
Patent practitioners, when drafting claims for medical treatments, should make sure that the claim is “particular, i.e., specifically identified, and is one that does not encompass all applications of the judicial exception” [Id. at page 14.] For example, in a medical treatment claim for a patent having a genotype associated with poor metabolism of beta blocker medications, a claim reciting “administering a lower than normal dosage of beta blocker medication” successfully integrates an unpatentable mental analysis step into a practical application [Id. at page 14.] The mentioned claim limitation meets the mentioned “particularity” requirement” [Id. at page 14.] On the other hand, a claim limitation that simply recites “administering a suitable medication to a patient,” would not satisfy Section 101; it is “instead merely instructions that ‘apply’ the exception in a generic way” [Id. at page 14.]
- Treatment/prophylaxis claim limitation having some relationship to the judicial exception
Secondly, a claim limitation, even though it is “particular,” must have some relationship to the unpatentable judicial exception also recited in the same claim. For example, a claim that recites a natural correlation (law of nature) between blood glucose levels over 250 mg/dl and the risk of developing ketoacidosis, can be made patent-eligible if it recites an administration step of “treating a patient having a blood glucose level over 250 mg/dl with insulin” [Id. at page 14.] Once again, this administration step is “particular,” and integrates the judicial exception into a practical application [Id. at page 14.] However, if that claim, using the mentioned natural correlation, instead recites “treating a patient having a blood glucose level over 250 mg/dl with Aspirin,” such a claim does not integrate the law of nature into a practical application” [Id. at page 14.] In this case, aspirin has no connection with ketoacidosis treatment or prevention [Id. at page 14.]
- Treatment/prophylaxis claim limitation imposing meaningful limits on the judicial exception
In addition, integrating a judicial exception into a practical exception for treatment claims can also be achieved by including a claim limitation that imposes meaningful limits on the judicial exception, as the following shows.
The October 2019 PEG Update considered a hypothetical claim having the following elements in the claim [Id. at pages 14–15]:
- administering rabies and feline leukemia vaccines to a first group of domestic cats in accordance with different vaccination schedules;
- analyzing information about the vaccination schedules and whether the cats later developed chronic immune-mediated disorders to determine a lowest risk vaccination schedule; and
- vaccinating a second group of domestic cats in accordance with the lowest-risk vaccination schedule.
Steps of the mentioned claim must be evaluated as a whole as noted as follows. For instance, step (a) is viewed as merely gathering data for a patent-ineligible mental analysis step and merely constitutes “extra-solution” activity, because it does not integrate the judicial exception into a practical application [ Id. at pages 14–15]. Also, step (b), like step (a), is patent-ineligible because it is classified as being within the mental process grouping of abstract ideas [Id. at pages 14–15]. However, since a claim must be considered as a whole when evaluating additional elements of a claim, step (c) makes the claim patent-eligible under 35 U.S.C. § 101 even though other limitations of the claim are not patent-eligible on their own [Id. at pages 14–15]. Step (c) applies the judicial exception by using the information from step (b) in order to determine the timeframe for vaccinating cats according to the lowest-risk vaccination schedule [Id. at pages 14–15].
For further examples relating to subject matter eligibility, patent practitioners and clients are advised to review the Appendix 1 to the October 2019 Update: Subject Matter Eligibility.
Consider the following five points when drafting the specification and claims in order to preemptively avoid Section 101 rejections:
(1) think of the concept best stated in Aristotle’s quote “[t]he whole is greater than the sum of parts” when claim-drafting for Section 101 purposes. Accordingly, additional limitations in a claim that integrate the judicial exception into a practical application can make a claim patent-eligible under Section 101 even though there are unpatentable parts within a claim;
(2) in view of the point (1), a claim, as a whole, which can be performed mentally despite reciting limitations concerning use of a pen or a computer, is still patent-ineligible;
(3) improvements in technology, irrespective of technical field, are important considerations for weighing patent-eligibility under Section 101; thus, such improvements in technology should be disclosed in the specification and be tied to specific limitations in a claim;
(4) for medical treatment claims, make sure to introduce specificity into the claims such as reciting a specific drug or dosage regimen in the claim and tying those specific details with the unpatentable judicial exception; and
(5) introduce meaningful limits on the judicial exception that go beyond recitation of a data-gathering step or a mental process.
By keeping in mind the October 2019 PEG Update’s suggestions and analysis, potential roadblocks to patent eligibility under Section 101 rejections might be avoided.
Acknowledgments: The author greatly appreciates the helpful comments by his colleagues, Irv N. Feit, Ph.D. and Laurence Manber, Ph.D. on a preliminary draft of this article.
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