Guide to the U.S. Patent Office’s Materials on Subject Matter Eligibility

Since 2014, the USPTO has periodically issued examination guidance, analysis examples, and other insights to guide evaluation of patent subject matter eligibility under 35 U.S.C. § 101.  These documents are available on the USPTO’s website and can be helpful in crafting arguments for or against the patent eligibility of claims during examination or in litigation.  The summary below is intended to assist the reader in locating relevant materials for a particular eligibility inquiry.

Before summarizing the materials, it is noteworthy that courts and the USPTO approach the subject matter eligibility test differently.  The courts implement a two-part test for eligibility.  Step one asks whether a claim is directed to a judicial exception.  If the answer is “no,” then the claim is patent eligible; but if the answer is “yes,” then step two asks whether the claim recites an inventive concept.  While these same two inquiries are made during examination of a patent application, examiners first make a preliminary inquiry under a different “step one” to determine whether the claims fall into one of the four statutory categories of patentable inventions.  If so, the examiner’s analysis continues to the two-part test developed by the courts, which the USPTO frames as steps 2A and 2B.

I.  Case Law Overview

For details of subject matter eligibility jurisprudence, the reader can download the USPTO’s chart of subject matter eligibility court decisions that provides information on selected eligibility cases from the Supreme Court and the Court of Appeals for the Federal Circuit.  This information includes a high-level summary of the subject matter, the claim type, the type of judicial exception (if identified), and the patent eligibility conclusion.  The quick reference sheet provides categorized snapshots of some of these cases, as outlined below.

• The first section highlights notable decisions holding claims eligible under step 2A, which tests whether the claim is “directed to” a judicial exception (such as an abstract idea).  This section lists eight decisions that determined the claims were not directed to an abstract idea, three decisions that determined the claims were not directed to a law of nature or natural phenomenon, and two decisions that determined the claims were not directed to a product of nature. 

• The second section highlights notable decisions holding claims eligible under step 2B, which determines—after the answer to step 2A is “yes”—whether a claim directed to a judicial exception recites an inventive concept.  This section lists nine cases relating to various judicial exceptions. 

• The third section lists numerous decisions relating to abstract ideas, categorized by the type of abstract idea involved—an idea “of itself,” fundamental economic practices, certain methods of organizing human activity, and mathematical relationships/formulas.

II.  Example Claim Analyses

The examples provided by the USPTO analyze subject matter eligibility, as summarized below.

• Abstract idea examples 1–8 (issued January 27, 2015)

1.      Isolating and Removing Malicious Code from Electronic Messages; hypothetical Claims 1–2 (eligible, step 2A: no)

2.      E-Commerce Outsourcing System/Generating a Composite Web Page; Claim 19 from U.S. 7,818,399 at issue in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014) (eligible, step 2A: no and step 2B: yes)

3.      Digital Image Processing; hypothetical Claims 1–3 (eligible, step 2B: yes)

4.      Global Positioning System; hypothetical Claims 1–2 (eligible, step 2B: yes)

5.      Digital Image Processing; Claim 10 from U.S. 6,128,415 at issue in Digitech Image Tech., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344 (Fed. Cir. 2014) (ineligible)

6.      The Game of Bingo; Claim 1 from U.S. 6,398,646 at issue in Planet Bingo, LLC v. VKGS LLC, 576 Fed. Appx. 1005 (Fed. Cir. 2014) (ineligible)

7.      E-Commerce providing Transaction Performance Guaranty; Claim 1 from U.S. 7,644,019 at issue in buySAFE, Inc. v. Google, Inc., 765 F.3d 1350 (Fed. Cir. 2014) (ineligible)

8.      Distribution of Products over the Internet; Claim 1 from U.S. 7,346,545 at issue in Ultramercial, LLC v. Hulu, LLC, 657 F.3d 1323 (Fed. Cir. 2014) (ineligible)

• Nature-based product examples 9–18 (issued December 16, 2014)

9.      Gunpowder and Fireworks: Product Claims That Are Not Directed To An Exception; hypothetical Claims 1–2 (eligible, step 2A: no)

10.  Pomelo Juice: Process Claim That Is Directed To An Exception And Product Claim That Is Not Directed To An Exception; hypothetical Claim 1 (ineligible) and hypothetical Claim 2 (eligible, step 2A: no)

11.  Amazonic Acid, Pharmaceutical Compositions, – Methods of Treatment; hypothetical Claim 1 (ineligible) and hypothetical Claims 2–8 (eligible, step 2A: no)

12.  Purified Proteins; hypothetical Claim 1 (ineligible) and hypothetical Claims 2–5 (eligible, step 2A: no)

13.  Genetically Modified Bacterium; hypothetical Claim 1 (ineligible) and Claim 2 at issue in Diamond v. Chakrabarty, 447 U.S. 303 (1980) (eligible, step 2A: no)

14.  Bacterial Mixtures; hypothetical Claim 1 (ineligible) and hypothetical Claim 2 (eligible, step 2A: no)

15.  Nucleic Acids; hypothetical Claim 1 (ineligible) and hypothetical Claims 2-4 (eligible, step 2A: no)

16.  Antibodies; hypothetical Claim 1 (ineligible) and hypothetical Claims 2–5 (eligible, step 2A: no)

17.  Cells; hypothetical Claim 1 (ineligible), hypothetical Claims 2–3 (eligible, step 2A: no), hypothetical Claim 4 (ineligible), hypothetical Claim 5 (eligible, step 2B: yes)

18.  Food; hypothetical Claim 1 (ineligible) and hypothetical Claim 2 (eligible, step 2A: no)

• Streamlined examples 19 and 20 (on slides 31 and 32) (posted March 6, 2015)

19.  Hip prosthesis; hypothetical Claim 1 (recites but is not directed to a nature-based product, eligible under streamlined analysis)

20.  Robotic arm assembly; hypothetical Claim 1 (recites but is not directed to mathematical relationships, eligible under streamlined analysis)

• Abstract idea examples 21–27 (issued July 30, 2015)

21.  Transmission Of Stock Quote Data; hypothetical Claim 1 (ineligible) and hypothetical Claim 2 (eligible, step 2B: yes)

22.  Graphical User Interface For Meal Planning; Claim 2 from U.S. 6,585,516 at issue in Dietgoal Innovations LLC v. Bravo Media LLC, 599 Fed. Appx. 956 (Fed. Cir. Apr. 8, 2015) (ineligible)

23.  Graphical User Interface For Relocating Obscured Textual Information; hypothetical Claim 1 (eligible, step 2A: no), hypothetical Claims 2–3 (ineligible), hypothetical Claim 3 (eligible, step 2B: yes)

24.  Updating Alarm Limits; Claim 1 at issue in Parker v. Flook, 437 U.S. 584 (1978) (ineligible)

25.  Rubber Manufacturing; Claim 2 from U.S. 4,344,142 at issue in Diamond v. Diehr, 450 U.S. 175 (1981) (eligible, step 2B: yes), hypothetical Claim 2 (eligible, step 2B: yes)

26.  Internal Combustion Engine; hypothetical Claim 1 (recites but is not directed to mathematical relationships, eligible under streamlined analysis)

27.  System Software ‐ BIOS; Claim 15 from U.S. 5,230,052 (recites no judicial exception, eligible under streamlined analysis)

• Life sciences examples 28-33 (issued May 4, 2016)

28.  Vaccines; hypothetical Claims 1, 2 and 4–6 (eligible, step 2A: no), hypothetical Claim 3 (ineligible), hypothetical Claim 7 (eligible, step 2B: yes)

29.  Diagnosing and Treating Julitis; hypothetical Claims 1 and 7 (eligible, step 2A: no), hypothetical Claim 2 (ineligible), hypothetical Claims 3–6 (eligible, Step 2B: yes)

30.  Dietary Sweeteners; hypothetical Claims 1–2 (ineligible), hypothetical Claims 3–6 (eligible, step 2A: no)

31.  Screening For Gene Alterations; Claim 1 at issue in Association for Molecular Pathology v. U.S. Patent and Trademark Office, 689 F.3d 1303 (Fed. Cir. 2012) (ineligible), hypothetical Claims 70 and 80 (eligible, Step 2B: yes), hypothetical Claims 75 and 85 (eligible, step 2A: no)

32.  Paper-Making Machine; hypothetical Claim 1 (recites but is not directed to a law of nature (gravity), eligible under streamlined analysis)

33.  Hydrolysis of Fat; hypothetical Claim 1 (recites but is not directed to chemical principles, eligible under streamlined analysis)

• Business method examples 34-36 (issued December 15, 2016)

34.  System for Filtering Internet Content; Claim 1 from U.S. 5,987,606 at issue in BASCOM Global Internet Servs. v. AT-T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016) (eligible, step 2B: yes)

35.  Verifying A Bank Customer’s Identity To Permit An ATM Transaction; hypothetical Claim 1 (ineligible), hypothetical Claims 2–3 (eligible, step 2B: yes)

36.  Tracking Inventory; hypothetical Claim 1 (ineligible), hypothetical Claims 2–3 (eligible, step 2B: yes)

III.  Examination Guidance

USPTO examination guidance documents explain how patent examiners should evaluate claims for patent subject matter eligibility.  A few important points from each document are noted below.

• The 2014 interim guidance on patent subject matter eligibility explains the use of the two-part test developed by the courts in examination procedures.  In particular, the 2014 interim guidance:

• states the “markedly different characteristics” test for analyzing nature-based products under step 2A

• sets forth examples of judicial exceptions based on the existing case law, including:

            –  laws of nature / natural phenomena (isolated DNA, correlations consequential to natural body metabolism, electromagnetism for signal transmission, chemical principles)

–  abstract ideas (mitigating settlement risk, hedging, contractual relationships, using advertising as currency, comparing new and stored information using rules to identify options, organizing information through mathematical relationships)

• provides examples of claim limitations that might be sufficient (or insufficient) to ensure that a claim recites an inventive concept, including:

–  applying the abstract idea via a particular machine

–  effecting a transformation or reduction of a particular article to a different state

–  adding a specific limitation other than what is well-understood, routine and conventional in the field

–  adding unconventional steps that confine the claim to a particular useful application

• The July 2015 update:

• provides further information on identifying abstract ideas under step 2A

• provides definitions of abstract ideas

–  fundamental economic practice = concepts relating to the economy and commerce that are old or well-known

–  certain methods of organizing human activity = interpersonal and intrapersonal activities (including mental activities)

–  an idea “of itself” = an idea standing alone, includes mental processes that can be performed in the human mind, or by a human using a pen and paper

–  mathematical relationships/formulas = algorithms and calculations

• lists computer functions that the courts have recognized as well-understood, routine, conventional functions when they are claimed in a merely generic manner

–  performing repetitive calculations

–  receiving, processing, and storing data

–  electronically scanning or extracting data from a physical document

–  electronic recordkeeping

–  automating mental tasks

–  receiving or transmitting data over a network, e.g., using the Internet to gather data

• The May 2016 update provides best practices for examiners to formulate a subject matter eligibility rejection and evaluate the applicant’s response, including the following:

• in formulating a section 101 rejection, “[w]hen the examiner has determined the claim recites an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim, and explain why it corresponds to a concept that the courts have identified as an abstract idea… Examiners should not go beyond those concepts that are similar to what the courts have identified as abstract ideas.” May 2016 update at 2–3 (emphasis in original).

• in evaluating an applicant’s response, “[i]f the original rejection did not identify a Supreme Court or Federal Circuit decision in which a similar abstract idea was found and applicant challenges identification of the abstract idea, the examiner would need to point to a case in which a similar abstract idea was identified and explain why the abstract idea recited in the claim corresponds to the abstract idea identified in the case to maintain the rejection.” Id. at 6.