Obviousness: Ranges and Substitutions

by Dennis Crouch

Almirall, LLC v. Amneal Pharmas LLC (Fed. Cir. 2022)

The court here affirms a PTAB conclusion cancelling claims 1-8 of Almirall’s U.S. Patent 9,517,219 as obvious.  The patent claims a method of treating acne/rosacea using a particular formulation:

  • Active Ingredient: about 7.5% dapsone;
  • Solvent: about 30% to about 40% diethylene glycol monoethyl ether;
  • Gelling Agent: about 2% to about 6% of A/SA; and
  • water;

[note – I edited these for compactness]. The claim also indicates that the composition “does not comprise adapalene.”  This concentration of the active ingredient was already known, the idea behind the invention here was to have a product that works well, that customers like, and that has a long shelf life. Thus, the figure submitted to the PTO shows shelf-life:

The prior art includes the commercial product (Aczone) that includes 7.5% dapsone and no adapalene. For the IPR, the PTAB looked at a patent application publication (Garrett) that described the Aczone product in detail.  Garret taught a different gelling agent — Carbopol rather than A/SA as required in the patent.  A different reference (Nadau-Fourcade) taught the use of A/SA agents in roughly the same concentration range for use in acne/rosacea products.  The Board found the combination appropriate and concluded that the claims were invalid.

Presumption of Obviousness: On appeal, the patentee argued that the Board improperly presumed obviousness based upon overlapping ranges. The basic argument is that A/SA was brought from a different reference and there should not be a presumption that its concentration would obviously be the same in the new combination.  On appeal, however, the Federal Circuit affirmed the Board’s ruling — finding that the presumption was appropriate here because the evidence proved similarity between carbomers (disclosed in Garret) and A/SA agents (substituted from Nadau-Fourcade)

The Board also credited expert testimony that a person of ordinary skill in the art
would have been able to immediately appreciate that the carbomers and A/SA agents at issue perform the same function and are interchangeable. Moreover, there was no evidence that A/SA agents would have different interactions with the other ingredients of the compositions relative to carbomer. Indeed, the Board credited expert testimony that a skilled artisan “would not have expected any incompatibilities in substituting” the gelling agents.

It was this close similarity in the substitution that allowed the range disclosures to create a presumption of obviousness.   In its decision, the court also notes that the stated presumption-of-obviousness is not any kind of burden shifting. Rather, it is simply shorthand for the proposition that overlapping ranges in the prior art justify a factfinder in concluding that the claimed range was  known in the art.  The patentee is free to provide evidence showing why its particular range is meaningful and thus non-obvious in the face of a similar disclosure range in the prior art.

Negative Limitation: The claims expressly exclude adapalene from the formulation. “[W]herein the … composition does not comprise adapalene.”  The key prior art reference (Garrett) does not even mention adapalene, and so, according to the patentee, we are left wondering whether Garrett might include the substance.  The Board rejected that argument as did the Federal Circuit.  In particular, the court restated its prior precedent that negative limitations need not be expressly stated in the prior art.  “[A] reference need not state a feature’s absence in order to disclose a negative limitation.” AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358 (Fed. Cir. 2019).

Reasonable Expectation of Success: Finally, the Court found that the Board had properly identified reasons to combine the references.  In particular, the patent challenger provided evidence that gelling compounds were effective and compatible substitutes. As such, the substitution of A/SA was a “predictable design choice.”  This falls within the Supreme Court’s guidance from KSR: “when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”

The court also places substantial weight on whether the substitution would have “a reasonable expectation of success.”  Here, though, expert testimony was provided regarding their interchangeability.  Further, [a] finding of a reasonable expectation of success does not require absolute predictability of success.”


11 thoughts on “Obviousness: Ranges and Substitutions

  1. 5

    Greg and MM about to finna love this range and substitution:

    “For a program initially constructed to provide resources for underserved people of color, the program consisted of a shockingly high number of wealthy, white, legacy students who presented me with the most outlandish understandings of identity I had ever heard. One boy told me that he was first-generation because his mother went to college outside of the U.S. His mother went to Oxford. Another girl told me that she was low-income because her dad makes $400,000 a year, and that’s “New York poor.” Each time another student offered ill-considered remarks on their background, I remember standing in front of them, eyebrows up and jaw dropped, thankful for the mask hiding my complete and utter disbelief. It was almost like clockwork: meet new classmate, ask about new classmate’s background, find out new classmate fails to comprehend or acknowledge their privilege, fre ak out, move on.

    The reality of life as a first-generation, low-income student isn’t something I would wish upon anyone. It certainly isn’t something to be thrown around by schools effectively inviting students to use their story-telling gifts to make their stories fit that identity. Giving under-resourced students a chance is redistributing privilege, not a power-up for applicants to play or a way for schools to signify diversity without actually working to create it.”

    The power of the story bruhs.

    link to yahoo.com

  2. 4

    Maybe we should apply Malcolm’s** obviousness sniff test.

    All of these active agents, solvents, and gelling agents are made up of protons, neutrons, and electrons that attach themselves in old and known ways.

    Result: obvious (and must just be a greedy no-good grab of protons, neutrons and electrons that demand to be free for the commune.

    ** granted, we ARE applying Malcolm’s “logic” to its reducto ad absurdium – but who would “question the science” that even mere groups of resistors in series versus in parallel are just mere known resistors, eh?

  3. 3

    In particular, the court restated its prior precedent that negative limitations need not be expressly stated in the prior art. “[A] reference need not state a feature’s absence in order to disclose a negative limitation.” AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358 (Fed. Cir. 2019)….

    If this is true, then why bother with negative limitations in the claims?

    1. 3.1

      There is no harm in trying, right? Sometimes it can fool an examiner into granting a patent claim that is presumed valid.

    2. 3.2

      Don’t. Don’t have negative limitations in the claim. It is 90% of the time a bad claim. There are, of course, exceptions, but they are truly exceptions. You have to be able to explain in the specification why the absence of the feature is notable and the difference between your invention without the feature and the art.

      I think coming up with new ways to simplify something that works as well or better than the prior are is very useful. It can also be difficult to claim and your specification will need a lot of support because the PTO is not convinced of what looks like lawyer post hoc arguments.

  4. 2

    Who was on the CAFC panel?

    Oh right, Dennis never mentions the panel composition. No need to, because the CAFC judges are in harmonious agreement about everything, always. So the outcome at the CAFC is never panel-dependent.

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