New Life Sciences Examples to Help Examiners (and Applicants) Interpret and Apply the Subject Matter Eligibility Analysis under 35 USC § 101 in View of SCOTUS and CAFC Case Law: Nothing Much New

 On May 6, 2016, the USPTO issued several documents (, including new Subject Matter Eligibility Examples for Life Sciences (including one that is directed to paper manufacturing), as well as a Memorandum to the Examiners for evaluating writing rejections and evaluating Applicant’s response (, and updates to the Index of Examples and summary of case law.

While these new Examples are directed to specific types of claims for which the public has been requesting guidance as to what is patent-eligible, and the majority of the exemplified claims are deemed patent-eligible, there is nothing remarkable or particularly enlightening about these Examples which would provide reason to believe that the USPTO is in any way changing their examination practices over the past few years, which have been in accordance with strict interpretations of the holdings in the series of cases that have caused increasing alarm in the life sciences patent community since the issuance of the Supreme Court decision in Mayo Collaborative Svcs. v. Prometheus Labs., 566 U.S. __, 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012), and its progeny.

Rather, the Examples and accompanying Memorandum provide more specific guidance to Examiners, setting forth in detail how the USPTO suggests that these rejections be formulated, including step-by-step analysis factors and exemplary language for the rejections, as well as requiring an analysis of all dependent claims, which can be both eligible when the claim from which it depends is ineligible, and vice versa.

Example 28: Vaccines 
The Example sets forth typical vaccine claims, wherein the patent-eligible claims include live attenuated (mutant) virus, inactivated virus that has been chemically modified (e.g., not just heat-killed); a naturally-occurring antigenic peptide in formulation with excipients that would not naturally occur in association with the peptide and which formulation has different structural and physical characteristics than its naturally occurring components (i.e., not just with water), and in conjunction with adjuvants that have a significant effect on efficacy. There is also an eligible delivery format claim for the otherwise ineligible antigenic peptide. The only patent-ineligible claim is a composition comprising the naturally-occurring antigenic peptide in formulation with water, which does not change its antigenic properties.
Example 29: Diagnosing and Treating (a disease) 
This Example, comprising 7 claims, 6 of which are patent-eligible, appears at first glance to expand the eligible subject matter of the problematic diagnostics claims, but unfortunately, a closer look reveals that nothing has changed. Patent-eligible claim 1 is a method of detecting a known protein with a generic antibody; however, it has nothing to do with diagnosing a disease per se. However, claim 2, directed to diagnosing a disease by detecting the protein with a generic antibody, and which adds the step of diagnosing the disease if the protein is present, is thereby transformed into a patent-ineligible claim. The rest of the claims either add a specific feature (claim 3: an unusual source for the antibody; claim 4: a specific monoclonal antibody); add method of treatment steps (claims 5 and 6, thereby most likely making the claims unenforceable for divided infringement), or are a typical method of treatment claim with no diagnostics involved (claim 7).

Ex. 30: Dietary Sweeteners (from a natural product) 

This Example addresses the patent-eligibility of natural products (or lack thereof) in admixture with water (claim 1 – ineligible), in a specific concentration in water (claim 2 – ineligible); in combination with a other compounds with which it is not normally found in nature (claims 3 and 4 – eligible); in the form of particular non-naturally-occurring particle sizes that have improved properties (claim 5 – eligible); and in a controlled-release formulation (claim 6 – eligible).
Example 31: Screening for Gene Alterations 
This Example simply repeats the analyses for 5 claims that relate to actual claim 1 from, and hypothetical claims 70, 75, 80, and 85 modeled after, the technology in U.S. Patent 5,753,441; claim 1 was held patent-ineligible in Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). The other four claims relate to using two different “data-gathering techniques,” stated in two different formats: either dependent on ineligible claim 1 (method of screening), or independently as methods of conducting the data-gathering techniques per se (method of hybridizing, method of amplifying). All of these four claims are said to claim significantly more than the judicial exception. The one interesting aspect of these “data-gathering techniques” is that the techniques are disclosed to be known – but not conventional – in the art.
Example 32: Paper-Making Machine 
While it is not immediately evident why this Example is in the “Life Sciences” Examples, it essentially based on the technology from U.S. Patent 845,224, which was upheld by the Supreme Court in Eibel Process Co. v. Minnesota & Ontario Paper Co., 261 U.S. 45 (1923). The hypothetical claim is directed to a machine which operates using gravity (a law of nature), the claim clearly does not seek to tie up this law of nature so that others cannot utilize it, and recites how an Examiner would do the streamlined analysis where there is no rejection for lack of eligible subject matter.
Example 33: Hydrolysis of Fat 
This Example, reciting a hypothetical claim based on the technology from U.S. Patent 11,766, which was upheld by the Supreme Court in Tilghman v. Proctor, 102 U.S. 707 (1881), which explains a streamlined analysis in a process claim which involves mixing two naturally occurring compounds (fat and water) and subjecting them to heat and pressure to hydrolyze the fat into glycerin and free fatty acids, but in which the claim has no recitation of a law of nature, and in which there is no rejection for lack of eligible subject matter.

There is not much new information in these new Examples, except perhaps that the analysis of the conventionality of the method used in the genetic screening claims (Example 31, last four claims) allows for unconventional methods of detection/”data-gathering” to pass muster for patent eligibility, even if the method is not per se novel. Although claim 1 of diagnostic Example 29 appears to suggest that merely eliminating the comparison step(s) would obviate the patent eligibility issue, that type of claim most likely would be directed to a prior art assay per se, and would not encompass the heart of the diagnostic invention, which is the comparison between analytes in a sample and a standard.

It is clear that the patent eligibility rejections in the life sciences are not going to be limited by pro-Applicant interpretation of the case law by the USPTO.

However, it should be noted that there is a growing discussion of and support for possible legislative proposals to overcome the judicial expansion of the judicial exceptions to patent eligible subject matter (laws of nature, natural phenomena, and abstract ideas) to find so many important inventions in the life-sciences and computer arts are per se not patentable-eligible. See, e.g.:

Unfortunately, it is clear that nothing is going to change soon to lessen the impact of these USPTO rejections on the life sciences and computer arts. In the meantime, patent applications continue to need to be drafted with these draconian judicial restrictions on patent eligible subject matter in mind.


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