Lighthouses in the Fog: Navigating the Gray Areas of Subject Matter Eligibility under 35 USC § 101

In 2014, the Supreme Court decided Alice v. CLS Bank1, confirming an algorithmic framework first presented in Mayo v. Prometheus2 for eligibility determinations under 35 USC § 101. Considerable attention has already been given to Mayo, Alice, and their progeny, as well as their potential legal ramifications.However, it is safe to say that the Alice decision cast a murky fog over the “anything under the sun that is made by man” eligibility standard to which innovators and practitioners had grown accustomed.

Although the long-term future of this framework for eligibility determinations is unknown4, the current framework is applicable at least in the immediate future. Therefore, a detailed understanding of how subject matter eligibility determinations are made under § 101, and how subsequent cases shed further light on the Mayo/Alice framework, is both valuable and useful to practitioners and innovators alike.

At the heart of the matter is § 101 itself, which states “…any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof …” is patent-eligible. Adding meat to these statutory bones is subsequent § 101 case law, which clearly outlines judicial exceptions—laws of nature, natural phenomena, and abstract ideas—that are not patent-eligible.An algorithmic approach to determining whether these exceptions preclude patent eligibility has resulted, as outlined below:

  • Is the invention directed to process, machine, manufacture, or composition?
  • Yes—Proceed to Step 2A6
  • No—Ineligible subject matter

(A) Is the invention directed to a law of nature, a natural phenomenon, or an abstract idea?

  • Yes—Proceed to Step 2B
  • No—Eligible subject matter

(B) Subtract out the law/s of nature, natural phenomena, or abstract idea/s, and is what remains “significantly more,” sufficient to render the claims directed to ineligible subject matter?

  • Yes—Eligible subject matter 
  • No—Ineligible subject matter

While this algorithmic approach is certainly significant, it does not paint the whole picture, nor consistently represent what either the United States Patent and Trademark Office (USPTO) or federal courts look for in eligibility determinations. A few recent cases in the realm of software and computer technology provide useful examples of how to get past this current § 101 hurdle7. These cases include Enfish,McRO9, BASCOM10, Amdocs11, and DataTreasury12. While failing to set precise boundaries as to what is or is not an abstract idea—which the Alice Court explicitly declined to do13—these cases have built on each other to provide clearer reference points as to what types of software claims are likely to be found eligible or not. Nevertheless, in the life sciences, uncertainty still looms due to the Federal Circuit issuing only one clear determination indicating eligible subject matter in the past few years.14 However, a few useful nuggets may be gleaned from this case as well.

So, what do courts and the USPTO look for in § 101 eligibility determinations? First, the USPTO and courts look for evidence that your claimed subject matter is not “directed to” a judicial exception (Step 2A). Enfish clarifies that this is a meaningful step.15 So whether you are drafting an application, responding to an Office Action, or describing your invention to a practitioner, make sure you include anything that shows your invention is not abstract, a law of nature, or a natural phenomenon. In this regard, broad, abstract language characterizing your invention should be avoided. Even if your claim language is broad, however, your claims may yet be directed to eligible subject matter if they are clearly supported by more detailed explanations in the specification.16 If your invention is software-based but designed to improve computer operations or performance, explain these improvements in detail. Even if the components of your invention seem routine on an individual basis, arrangements of known pieces may provide the necessary “inventive concept” for eligibility if the arrangements are non-conventional and non-generic.17 Also, make sure the written description of your invention includes a few points showing how your solution differs from (and improves upon) other known solutions.18

Second, courts and the USPTO look for inventions that are cast as a series of steps that lead to a solution to a problem. Thus, consideration should be given as to whether an invention may be described as an “ordered combination.”19 An invention that fits this mold appears to have a greater chance at overcoming either of Steps 2A and 2B.20 With software or computer technology, the USPTO provides a few hypothetical examples depicting ineligible and eligible ordered combinations.21 In this regard, a closer look at differences between claims 1 and 2 of Example 21 of the 2015 Interim Guidelines on Patent Subject Matter Eligibility22 will prove useful.

Third, courts and the USPTO are inclined to reject as ineligible patents that try to preempt the field.23 In other words, as the problem your innovation aims to solve may have other possible solutions, leave room for others in your field to make their own improvements. Rather than attempting to claim the result or outcome achieved, your claim language should focus on the particular novel path that got you there—in other words, your technological solution to the technological problem at hand.24

In the realm of life sciences, the decision that carries the banner for eligibility is Cellzdirect.25 Because the invention in this case does not preempt the field due to a reasonably limited application26, because the invention solves a known viability problem27, because the solution is presented as an ordered combination of steps28, and because the claims and specification correlate to show the invention is “directed to” a new process of preserving cells29, CellzDirect provides a useful guidepost for inventors and practitioners describing and pursing an invention in the life sciences.

With the rays of light these cases provide, the murky fog of subject matter eligibility is beginning to lift at least with respect to software innovations, even if there remains no bright-line path. And, as those in the software and computer-related industry enjoy added clarity due to recent case law, it is hoped that the life sciences will also receive additional clarity in the days ahead. 

Suiter Swantz IP is a full-service intellectual property law firm serving all of Nebraska, Iowa and South Dakota. If you have any intellectual property questions or need assistance with any patent, trademark or copyright matters and would like to speak to one of our patent attorneys please feel free to contact us.


Alice Corp Pty. Ltd. v. CLS Bank International, 573 U.S. __, 134 S. Ct. 2347 (2014).
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ____, 132 S.Ct. 1289 (2012).
3 Rantanen, Jason, Alice v. CLS Bank: Claims Invalid Under Section 101, Patently-O, (https://patentlyo.com/patent/2014/06/claims-invalid-section.html); see also, Borella, Michael, Section 101 and the Growing Alice Backlash, Patent Docs, Biotech & Pharma Patent Law & News Blog, (http://www.patentdocs.org/2016/05/section-101-and-the-growing-alice-backlash.html) (last visited 03/02/2017).
4 Poulsen, Matt, Is It Time to Amend the Test for Patent Subject Matter Eligibility?, (http://www.suiter.com/is-it-time-to-amend-subject-matter-eligibility/) (last visited 03/02/2017).
5 See, e.g., Alice, 134 S. Ct. at 2354 (quoting Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116 (2013)). See also Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980).
6 Note that some courts may refer to steps 2A and 2B as “Alice, step one” and “Alice, step two” respectively. See, e.g., Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1339 (Fed. Cir. 2016).
7 It should be noted that the Mayo/Alice framework has become standard for determining the eligibility of software patents even though neither Mayo nor Alice dealt with the eligibility of software per se.
Enfish, 822 F.3d at 1698.
9 McRO, Inc. dba Planet Blue v. Bandai Namco Games America Inc., 837 F. 3d 1299, 120 USPQ2d 1091 (Fed. Cir. 2016).
10 BASCOM Global Internet Services v. AT&T Mobility LLC, 827 F .3d 1341 (Fed. Cir. 2016).
11 Amdocs (Israel) Ltd. v. Openet Telecom, Inc., 841 F. 3d 1288 (Fed. Cir. 2016) CAFC Appeal No. 15-1180.
12 DataTreasury Corp. v. Fidelity National Information Services, _ Fed. Appx. _ (Fed. Cir. 2016) CAFC Appeal No. 16-1046. Additionally, Trading Technologies, Int’l., Inc. v. CQG, Inc., Appeal No. 2016-1616 (Fed. Cir. 2017), while nonprecedential, upholds a district court ruling that Trading Technologies’ patents, directed to a graphical user interface (GUI) for a commodity trading platform, were directed to patent-eligible material, providing specific technological improvements over prior art GUI systems. Per the district court, Trading Technologies’ claims were not directed to an abstract idea, and recited sufficient “inventive concept.” See Trading Techs., Int’l, Inc. v. CQG, Inc., http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1616.Opinion.1-13-2017.1.PDF (last visited 2017-03-13).
13 Alice, 134 S.Ct. at 2357 (“… we need not labor to delimit the precise contours of the ‘abstract ideas’ category in this case.”).
14 Rapid Litigation Management v. Cellzdirect, 827 F.3d 1042, 119 U.S.P.Q.2d 1370 (Fed. Cir. 2016).
15 Enfish, 118 U.S.P.Q., at 1698; see also Cellzdirect, 827 F.3d at 1050.
16 In Amdocs, for example, the court read into the single word “enhance” in the claims a distributed architecture explained in detail by the specification, which “distributed architecture” provided a critical improvement over the prior art. See Amdocs, 841 F. 3d at 1300.
17 See BASCOM, 827 F. 3d at 1350.
18 See McRO, 120 USPQ 2d at 1112; see also, Brief for Appellant, at 156-157, DataTreasury Corp. v. Fidelity Nat’l, _ Fed. Appx. _ (Fed. Cir. 2016) CAFC Appeal (No. 16-1046), and also Order and Judgment, at 1-2.
19 See McRO, 837 F. 3d, at 1312-13 (citing Alice, 134 S. Ct., at 2358).
20 Id. See also BASCOM, 827 F. 3d, at 1348-1350.
21 2015 Interim Guidelines on Patent Subject Matter Eligibility, (https://www.uspto.gov/sites/default/files/documents/ieg-july-2015-app1.pdf) (last visited 03/02/2017).
22 Id., pp. 1-5.
23 See, e.g., DDR Holdings, LLC v. Hotels.com, LP, 773 F.3d 1245, 1256-60 (Fed. Cir. 2014); Amdocs, 841 F.3d, at 1302; and McRO, 837 F. 3d, at 1315.
24 See, e.g., DDR Holdings, 773 F. 3d at 1257.
25 Supra, note 14.
26 CellzDirect 827 F.3d, at 1045; see also, BASCOM, 827 F. 3d, at 1350 & 1352.
27 Id., at 1045-1046.
28 Id. at 1051-1052.
29 Id. at 1047-1050; see also, BASCOM, 827 F. 3d, at 1347-49.

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