By: Vincent Meyer

I. Introduction

The question individuals often ask is, “what protection does a patent provide?”  It is not a right to manufacture, or make a device.  Rather, it is a right to exclude others from capitalizing—in any way—on the claimed invention.[1]

Patents provide their owners with a limited monopoly, and in doing so, they provide an economic incentive for individuals and companies to innovate.[2]  However, there are limitations on what is patentable.  One such limitation is found in 35 U.S.C. § 101, which codifies subject matter eligibility (SME).[3]

In Alice Corporation Pty. Ltd. v. CLS Bank International, the court established a two-part test.[4]  The first part of this test requires determining whether a patent claim is directed to an abstract idea.[5]  If it is, the next step is to determine if the claim adds something to transform the idea into a patent-eligible one.[6]</

Technological advances have presented difficulty for determining patent SME, particularly in the area of software patents.[7]  Software is difficult to patent because, in interpreting patent law, software is often thought to be an abstract idea.[8]  However, this generalization of software as unpatentable because of its abstractness is dangerous, because some types of software are more vital to society than others.[9]  In particular, software in the healthcare field, such as software utilized as a medical device (hereinafter medical software) and electronic health records (EHR), are very valuable to society, as it  allows for more efficient healthcare of individuals.[10]

The medical device industry is a quickly growing market, expected to be worth $477.5 billion worldwide by 2020.[11]  Medical devices include software to allow motors to know when to actuate in artificial heart pumps, for example, or the technology that processes images and assists in the diagnosis of cancer and other deadly diseases.[12]  EHR software allows for easy access to patients’ files, and allows physicians to communicate with one another regarding patients, making the care of patients easier and more efficient.  The market for EHR was estimated at $20.55 billion in 2016 and is expected to continue in an upward trend over the coming years.[13]  One issue that has been rampant is usability, but as the market becomes more profitable, new players enter the market, innovations in the software continue to make it more user-friendly, and doctors become more efficient in patient care.[14]

Currently, efficiency is generally not enough to push a claim past abstraction as required in the first part of the Alice test.[15]  Therefore, this Article argues that efficiency should be a recognized exception to abstraction for medical device and EHR software.

II. Background
A. How the Courts Arrived at the Two-Part Alice Test

In Diamond v. Chakrabarty, one of the earliest cases dealing with SME, the Supreme Court construed section 101 broadly to include “anything under the sun that is made by man.”[16]  They later narrowed it slightly by defining “laws of nature, natural phenomena, and abstract ideas.”[17]  The Supreme Court again put forth a broad construction in State Street Bank & Trust Co. v. Signature Financial Group, a case dealing with software that transformed data.[18]  The Court deemed the claim to have SME because the algorithm’s output was useful, concrete, and tangible.[19]

The next test put forth was the narrower “machine or transformation” test laid outin Gottschalk v. Benson, which was a case that dealt with a program that transformed numerical data.[20]  In order to have SME, it was deemed that a claim must be tied to a particular machine or apparatus or must change materials into a different state or thing.[21]  In the 2008 case In re Bilski, which dealt with a business method patent, the Supreme Court adopted this method, and rejected the “useful concrete, and tangible” test, affirming the Court of Appeals for the Federal Circuit’s (CAFC) holding that a method for hedging risks was unpatentable.[22]  However, on appeal, the Supreme Court adopted a more conservative view of the machine or transformation test, and said it was but one factor to be considered in determining SME.[23]  This test had been developed in the Industrial Age, before software technology was even fathomable, so its applicability was to be given some, but not too much weight.[24]  This left some uncertainty as to SME.

Alice and Mayo Collaborative Services v. Prometheus Labs., Inc. provided some clarity in this ever changing landscape of SME.[25]  In laying out the two-part test, the Supreme Court clarified the standard to some extent, but still had to decide what constituted an abstract idea.

B. Tests of Abstraction

Courts have faced much difficulty in determining what constitutes an abstract idea per step one of Alice and Mayo.[26]  As a result, courts have formulated a few different, yet very similar, tests to determine what is abstract.

One such test is the “human mind” test, wherein the court asks whether or not a problem can be solved in the human mind.[27]  In Bancorp Services LLC v. Sun Life Assurance Company of Canada, the CAFC held that the use of a computer to expedite a mental process—i.e., to increase efficiency—that would otherwise be ineligible does not give a patent SME.[28]  The claims must show a computer or software that can facilitate the process in a way that a person making calculations could not.[29]

Then, there is the “pen and paper” test, which says that if a task can be performed with pen and paper, it is an abstract idea.[30]  In Cybersource Corporation v. Retail Decisions, Inc., the CAFC held a claim for a method for detecting fraudulent credit card transactions between a consumer and merchant over the internet to be invalid for lack of SME.[31]  The task could be performed—albeit less quickly—using pen and paper.[32]

Next, there is the “human interactions” test, which was used in Cogent Medicine v. Elsevier, Inc.[33]  There, a claim for a database, which kept a record of up-to-date medical research, was held to be invalid because it merely computerized a task which humans could do, just less efficiently.[34]

In Enfish, LLC v. Microsoft Corp., the Supreme Court determined that a logical model which created a self-referential table was not an abstract idea.[35]  The Court differentiated this from other cases involving software, stating that the claims were directed to an improvement in computer functionality, not an abstract idea.[36]  This case provides some reassurance to those who want to patent software, because it shows that it is possible to do so.

C. Benefits of EHR and Medical Diagnosis Software

As Medtronic stated in an amicus curiae brief in Bilski v. Kappos, medical diagnosis and its improvements are very useful.[37]  Diagnostic software can compare parameters of individuals to others with similar health conditions to help diagnose potential issues before they even occur, which increases the chances of saving lives.[38]

EHR provides much of the same benefit.[39]  By allowing physicians to communicate amongst each other regarding common patients, the treatment of individuals becomes more efficient and less costly.[40]

III. Analysis

These tests apply to all software, including medical software and EHR.  Alice has acted both favorably and unfavorably for medical software.[41]  The question remains, how would these tests be used to analyze medical software and EHR.

A. Useful, Concrete, and Tangible Result

The broad “useful, concrete, and tangible result” test set forth in State Street Bank would be favorable for medical software.[42]  The Court emphasized the “useful” part of the test.[43]  Under that analysis, both EHR and medical software would be considered to have great utility.  For example, diagnosis software makes it easier for physicians to diagnose and pretreat illnesses, and EHR systems allow for physicians to communicate about common patients in a more efficient manner.[44]  The test does not lay out a narrow definition of utility, so it would seem that the advantages of medical software and EHR would give them SME.

B. Machine or Transformation Test

Medical software and EHR would fail the narrow machine or transformation tests.  As noted in Bilski v. Kappos, the machine or transformation test was employed in the Industrial Age, wherein a number of claims were tied to specific machines, or altered the machines in a unique way.  However, there is an argument to be made here in that medical software for diagnosis and EHR software are tied to their particular medical instruments and computers.

C. Mayo/Alice Two-Part Test

Under current formulations of the two-part Mayo/Alice test, most medical software and EHR would fail for lack of SME, because ineligible abstract ideas that do not have an element pushes them into the realm of non-triviality.  Otherwise, some of the tests do not quite work in the context of today’s software and computing capabilities.

1. Human Mind Test

Under the “human mind” test, medical software would be considered a patent-ineligible abstract idea  As this test is set forth in Bancorp Services, this certainly would not pass abstraction, because it merely speeds up the process.[45]  Pathologists know what to look for when reading the results of a CT scan.  It seems that diagnosing diseases, such as fatty liver, can be done easily with the human mind after viewing an image from a CT scan or an MRI.[46]

EHR would also fail the human mind test.  Some have argued that it is virtually impossible to store patient files by hand.  However, it is possible and can be done without the use of EHR systems.  Efficiency is not a factor considered under this test of abstraction and therefore, it does not make EHR a non-abstract idea.[47]

2. Pen and Paper

The “pen and paper” test is literal and straightforward, essentially saying that an idea is abstract if it can be done using pen and paper.[48]  Algorithms can be written out, but without a computing processor to execute the algorithm, it is useless.[49]  In other types of medical software, such as diagnostic software, diagnoses can be performed using pen and paper, which presents an issue for medical software in this context.[50]

EHR performs the task of tracking patient data and allowing physicians to communicate with each other.[51]  This can be done using pen and paper, but again, this does not quite fit the bill because of the communication steps in between.

3. Human Interactions

Diagnosing a medical issue is indeed a task that is carried out by doctors, and thus can be carried out by people, which, under the definition of the “human interactions” test set forth in Cogent, would make this trivial and therefore abstract.  There is some merit to an argument that medical software is not like the information in Cogent, and that it is much more complicated.  For example, while diagnosis of a patient can be carried out by doctors, medical diagnosis software improves it.[52]  Diagnosis software does not merely compile information like research databases.  Rather it saves time, and is far from trivial.[53]

Record keeping can be done by assistants using files and file cabinets, so under the current formulation of abstraction, EHR is essentially a database of health records, but it is far different from a mere collection of publicly available research articles.[54]  Further, EHR implicates privacy issues which research articles do not do because of their general availability.  There are more intricacies with EHR.

4. Improvement of Functionality

It is possible for medical software and EHR to make it through Alice because they are not abstract ideas under the analysis in Enfish.[55]  However, purely viewing the issue from the standpoint that medical diagnostic software improves the functionality of the equipment could be a valid argument for getting past step one of the Alice test.  Medical diagnostic software improves the efficiency of diagnoses.[56]   There could be an argument as to whether this goes to the efficiency of the equipment or the efficiency of the doctor making the diagnosis.  If it goes to the efficiency of the doctor, then it is clearly abstract.  However, if it goes to improving the equipment itself, then it is not so easily abstract.

The same tests may also be applied to medical software, such as EHR software.  It seems more likely that this medical software would pass muster because it is somewhat closer to the software in cases such as Enfish.  It would be improving the efficiency of the information systems in hospital, not the efficiency of the doctors.

Medical software and EHR would most likely fail with two of the four tests.  The formulation of the court in Enfish would most likely be favorable, and the pen and paper test would not quite fit the bill.

IV. Recommendation

It is very difficult to strike the balance that patent law looks to achieve between  incentivizing people to come up with new inventions and impeding progress in certain areas .  Medical software is one such area where this problem rings true, as over the past few years, technology, such as EHR and diagnostic software have allowed for more effective healthcare.[57]  Medical innovation needs to be encouraged, but at the same time, we do not want people monopolizing the area, as that would ultimately impede innovation  There are two potential solutions to the problem presented by medical software.

A. Efficiency is a Benefit That is Not Abstract

First, efficiency improvement should be considered a non-abstract idea, even if it is only for medical software, EHR, or other types of software that provide life-saving benefits that are not attenuated from the use of the product.  Many improvements in medical device software allow for quicker diagnosis and more effective treatment of patients.[58]   Further, applying this type of test is still not so broad that innovation in the medical field would be impeded.  This is a good way to vet out medical diagnosis software and electronic health record software, and maintain the incentive to innovate in the medical software community.  It is certainly not true that every medical software improves efficiency, and thus medical software that is truly abstract could be vetted out in the second step.  However, for the software that does, those should make it through the first step of section 101.  This would keep the medical software market from flooding with useless patents and allow for maintenance of innovation.

One key difference between medical device software and other types of software is that when making a diagnosis, time is of the essence.  Therefore, in one aspect, it seems that diagnosis of medical issues is more important, and the software that performs this task is of greater significance than other types of software.  While it may be true that adding efficiency to bank systems and systems that assist in cash flows—such as the one in Bilski—provides societal benefits, such systems are not life-saving.  With EHR and medical software, the effects are the direct result of the use of the technology.  While it is true that sometimes process improvements are trivial, those in EHR and medical diagnosis software are not.  EHR and medical diagnosis software make the process flow more smoothly.  If a software provides benefits that go beyond, for example, financial assistance, in such an important way, there should be an exception to the courts’ longstanding rule of not allowing efficiency improvements to be a point of eligibility.[59]

B. Use a Broad Interpretation as in Enfish

Another possible solution is the solution provided in Enfish.  If the functionality of the device or system is improved, the idea is not abstract.[60]  In the case of medical software, this overcomes the abstract issue, because medical diagnosis software, for example, increases the efficiency, and thus, the functionality of the diagnostic machine.[61]

EHR helps the information system work efficiently as a whole in hospitals;[62]  it does not just improve the efficiency of the person using the machine.  Therefore, it would pass muster under the Enfish analysis.[63]  This test, as described in Enfish, works to filter out abstract ideas using efficiency, because the machine, not the person, is what is improved.[64]

V. Conclusion

Medical software should be subject to different standards of scrutiny when it comes to determining SME.  Such software has implications that are not found in financial software and other types of commercial software that companies often seek to patent.  In order to accommodate the important implications involved with medical diagnosis and EHR software patents, courts should consider efficiency because in terms of social utility, it is far more useful that other types of software..  The court can do this in multiple ways, including specifying that the improvements must be made in the functionality of a particular machine, instead of the user.  Either way, it must be done in such a way that the policy goals of protecting innovation while not impeding further innovation in the field will prevail.  Utilizing efficiency and improvements in functionality will accomplish this goal.

[1] 35 U.S.C. § 154(a)(1) (2012).

[2] See, e.g., Kristina Lybecker, How to Promote Innovation: The Economics of Incentives, IPWatchdog (July 21, 2014), (discussing innovation in connection with patent ownership).

[3] 35 U.S.C. § 101 (2012).

[4] Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2357(2014).

[5] Id.

[6] Id.

[7] See, e.g., Gene Quinn & Steve Brachmann, Medical Software Provides Life-Saving Results, Not Abstract Ideas, IPWatchdog (Aug. 26, 2016), (discussing the difficulties of the Alice test and the idea that software is an abstract idea).

[8] Id.

[9] Id. (discussing medical software and the non-trivial benefits it provides).

[10] Quinn & Brachmann, supra note 7.

[11] Jof Enriquez, Report: By 2020, Global Medtech Market Worth $477.5 Billion, Medtronic Top Device Maker, Med Device Online (Oct. 6, 2015),

[12]What are Examples of Software as a Medical Device?, FDA, (last visited Mar. 14, 2018)

[13] Report Summary: Electronic Health Records (EHR), Market Analysis by Product (Client Server-based, Web-based), by Type (Acute, Ambulatory, Post-Acute), by End-use (Hospitals, Ambulatory Care, and Segment Forecasts, 2014-2025, Grand View Res. (last visited Mar. 14, 2018)

[14] Id.

[15] See John A. Rothchild et al., Research Handbook on Electronic Commerce Law 248 (2016) (discussing efficiency in court determinations of SME).

[16] Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).

[17] Diamond v. Diehr, 450 U.S. 175, 185 (1981).

[18] State Street Bank & Trust Co. v. Signature Financial Group 149 F.3d 1368, 1370, 1373 (1998).

[19] Id. at 1373.

[20] Gottschalk v. Benson, 409 U.S. 63, 64-65 (1972).

[21] Id. at 70.

[22] In re Bilski, 545 F.3d 943, 959-60 (Fed. Cir. 2008).

[23] Bilski v. Kappos 561 U.S. 593, 593 (2010).

[24] Id. at 605.

[25] Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2357(2014); Mayo Collaborative Services v. Prometheus Labs., Inc. 132 S. Ct. 1289, 1294 (2012).

[26] Alice, 134 S. Ct. at 2357; Mayo, 132 S. Ct. at 1294.

[27] See Rothchild et al., supra note 15, at 245 (discussing the human mind test).

[28] Bancorp Services, L.L.C. v. Sun Life Assur. Co. of Canada, 687 F.3d 1266, 1278 (Fed. Cir. 2014).

[29] Id.

[30] See, e.g., Rothchild et al., supra note 76, at 244 (discussing the pen and paper test).

[31] CyberSource Corp. v. Retail Decisions, 654 F.3d 1366, 1367, 1372 (Fed. Cir. 2011).

[32] Id.

[33] See, e.g., Rothchild et al., supra note 76, at 244; Cogent Medicine, Inc. v. Elsevier Inc., 70 F. Supp. 3d 1058, 1060 (N.D. Cal. 2014).

[34] Cogent Medicine, 70 F. Supp. 3d at 1060, 1064.

[35] Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1330, 1339 (2016).

[36] Enfish, 822 F.3d at 1335—36.

[37] See Quinn & Brachmann, supra note 7 (discussing the amicus curia brief written by Medtronic in Bilski).

[38] Id.

[39] See Dr. Robert Hoyt, Benefits of Switching to an Electronic Health Record, Practice Fusion (last visited Mar. 14, 2018) (discussing the benefits of EHR).

[40] Id.

[41] See Quinn & Brachmann, supra note 7 (discussing the difficulty medical companies have faced in patenting medical software).

[42] State Street Bank & Trust Co. v. Signature Financial Group 149 F.3d 1368, 1373 (1998).

[43] Id.

[44] See, e.g., Quinn & Brachmann, supra note 7; see also Hoyt, supra note 39 (discussing the benefits of EHR).

[45] Bancorp Services, L.L.C. v. Sun Life Assur. Co. of Canada, 687 F.3d 1266, 1278 (Fed. Cir. 2014).

[46] See, e.g., Quinn & Brachmann, supra note 7.

[47] Rothchild et al., supra note 15, at 248.

[48] Id. at 244.

[49] Id. at 245.

[50] See, e.g., Hoyt, supra note 39.

[51] See Electronic Health Records, Centers for Medicare & Medicaid Services, (last visited Mar. 14, 2018) (discussing how EHR provides for more efficient care for patients).

[52] See, e.g., Hoyt, supra note 39.

[53] See, e.g., Quinn & Brachmann, supra note 7 (discussing the benefits of advances in medical software).

[54] Hoyt, supra note 35; see also Why Is Early Diagnosis Important?, Cancer Res. UK, (last visited Mar. 14, 2018) (discussing the importance of diagnosing cancer in its early stages for better results).

[55] Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1330, 1335–36 (2016).

[56] See, e.g., Hoyt, supra note 39.

[57] Id.

[58] See, e.g., Hoyt, supra note 39; see also Why Is Early Diagnosis Important?, supra note 54 (discussing the importance of diagnosing cancer in its early stages for better results).

[59] Rothchild et al., supra note 15, at 248.

[60] Enfish, 822 F.3d at 1335–36.

[61] See, e.g., Hoyt, supra note 39.

[62] Id.

[63] Enfish, 822 F.3d at 1335–36.

[64] Id.