Teaching Points from the New USPTO Life Sciences Examples

life-science-moleculesOn May 6, 2016, the U.S. Patent and Trademark Office released new life science examples on subject matter eligibility (Examples 28-32, consecutively numbered after the previously released USPTO examples). Examples 28 and 30 illustrate the application of the “markedly different” and “significantly more” analysis to nature-based products. Examples 29 and 31 illustrate the USPTO approach to the eligibility analysis of diagnostic claims, which has been much anticipated. Finally, Examples 32 and 33 illustrate the use of a streamlined eligibility analysis. At first glance, the new life science examples, which identify most of the presented hypothetical claims as patent-eligible, provide several teaching points for achieving patent-eligibility in commonly encountered situations in the life sciences area.

The USPTO analysis of the claims used in the examples is based on 2014 Interim Guidance on Patent Subject Matter Eligibility, 79 Fed. Reg. 74,618 (Dec. 16, 2014). Briefly, the Guidance asks whether the claim is directed to a “judicial exception” – law of nature, natural phenomenon, or an abstract idea. Natural phenomena include “nature-based” products. A claim that recites a nature-based product that does not exhibit “markedly different” characteristics from its naturally occurring counterpart is directed to a “product of nature” judicial exception (“markedly different characteristics” analysis). The claim that is directed to a judicial exception must be analyzed to determine whether it recites additional elements which amount to “significantly more” than the judicial exception.


Nature-based products

Example 28 presents a set of influenza vaccine claims; and Example 30 presents a set of composition claims directed to a dietary sweetener comprising a naturally occurring plant compound, in various formulations. Examples 28 and 30 teach us that patent eligible “nature-based” product claims may be achieved by demonstrating that the difference in the structural properties of the products or their components results in a beneficial alteration of their functional properties. Reciting various property-altering carriers and formulations may help to reach this goal. In the absence of a beneficial alteration of the functional properties, applicants may consider the claims reciting the devices for administering or otherwise using the natural products to a beneficial effect.


Diagnostic claims

Example 29 presents diagnostic and treatment claims using a hypothetical disease; and Example 31 presents a set of claims based on the BRCA1 gene claims of U.S. Patent 5,753,441. Diagnostic claims are often regarding by the USPTO as directed to “law of nature” and/or “abstract idea” exceptions. Examples 29 and 31 teach us that it may be the easiest to avoid a patent eligibility analysis of such claims by omitting the steps that can be interpreted as being directed to a “law of nature,” “abstract idea,” or both. Such steps may use the words “diagnosing,” “comparing” or “correlating.” These examples also teach us that patent eligible diagnostic claims may be achieved by including technical steps that were not routine or conventional at the application filing date. Adding a treatment (“administering”) step may also lead to patent eligibility. In some cases, the USPTO expects the treatment to steps to be unconventional (Example 29, claim 5). But USPTO also seems to instruct us in Example 29, claim 6, that patent eligibility may be based on a conventional treatment step coupled with an argument that the claim as a whole integrates the exception into a diagnostic and treatment process that is not routine or conventional, for example, because it avoids previously common misdiagnoses and ensures proper treatment.


Streamlined Analysis

Under the Guidance, streamlined analysis circumvents the full-blown patent eligibility investigation for the claims that clearly do not seek to tie up any judicial exceptions such that others cannot practice them. As an illustration, Example 32 presents a claim directed to a paper-making Fourdriner machine that uses a law of nature – gravity; and Example 33 presents a set of process claims for obtaining free fatty acids and glycerol from fat. Examples 32 and 33 teach us that including unconventional structures and processes arranged in a particular way for using a law of nature may induce the USPTO to use the streamlined analysis.

In summary, the new life sciences examples seem to use more relaxed criteria of patent eligibility than the earlier examples. “Markedly different characteristics” of the claims directed to nature-based products may be achieved not only by changing the structure of the nature-derived components, but also by using the formulations, carries or devices leading to some beneficial effects. Patent eligibility analysis of diagnostic claims may be avoided altogether by omitting “diagnosing,” “comparing” or similar steps. If such steps are included in diagnostic claims, unconventional treatment steps may steal make them patent-eligible. Even a diagnostic claim using a conventional treatment step may be patent eligible, if the resulting integrated diagnostic and treatment process is not routine or conventional. Finally, including specific and unconventional structural or technical limitations in the potentially suspect claims may prevent full-blown patent eligibility analysis.

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2 comments so far.

  • [Avatar for Anon]
    May 16, 2016 08:14 pm


    Not a word about the recent Federal Circuit decision that all but dismissed the previous renditions of Office guidance as having ZERO legal effect?

    That is a rather large elephant in the room – no matter what the Office has to say this time around.

    Given that court’s rather direct statement, the best that an attorney would do for their client is to counsel that the Office views here may (and only may) get you through the examination phase, but carry zero weight as to you obtaining a patent that would be enforceable in a court of law.

  • [Avatar for Appearance of ...]
    Appearance of …
    May 16, 2016 10:49 am

    Unfortunately examiners may read these examples narrowly — somewhat like the rules of hearsay evidence, and only allow patents that fit the examples very closely. Is the sum of the various “judicial exceptions” in effect mapping patent eligibility into something akin to the rules of hearsay? Is the rule ultimately going to be that everything is prohibited unless it fits certain narrow exceptions?