July 22, 2024


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Obviousness: Ranges and Substitutions | Patently-O


by Dennis Crouch

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

The court docket listed here affirms a PTAB summary cancelling statements 1-8 of Almirall’s U.S. Patent 9,517,219 as noticeable.  The patent promises a strategy of dealing with zits/rosacea utilizing a individual formulation:

  • Lively Component: 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
  • h2o

[note – I edited these for compactness]. The declare also signifies that the composition “does not comprise adapalene.”  This concentration of the lively ingredient was previously identified, the idea guiding the invention listed here was to have a solution that works well, that buyers like, and that has a extensive shelf life. Hence, the determine submitted to the PTO exhibits shelf-existence:

The prior artwork involves the business item (Aczone) that consists of 7.5% dapsone and no adapalene. For the IPR, the PTAB looked at a patent software publication (Garrett) that described the Aczone product or service in element.  Garret taught a distinct gelling agent — Carbopol fairly than A/SA as expected in the patent.  A distinctive reference (Nadau-Fourcade) taught the use of A/SA brokers in roughly the same focus variety for use in zits/rosacea goods.  The Board found the mixture suitable and concluded that the statements were invalid.

Presumption of Obviousness: On enchantment, the patentee argued that the Board improperly presumed obviousness dependent on overlapping ranges. The simple argument is that A/SA was brought from a distinctive reference and there must not be a presumption that its concentration would definitely be the identical in the new blend.  On attractiveness, nevertheless, the Federal Circuit affirmed the Board’s ruling — locating that the presumption was correct here for the reason that the proof proved similarity in between carbomers (disclosed in Garret) and A/SA agents (substituted from Nadau-Fourcade)

The Board also credited qualified testimony that a man or woman of normal skill in the artwork
would have been capable to right away recognize that the carbomers and A/SA brokers at concern conduct the identical operate and are interchangeable. In addition, there was no proof that A/SA brokers would have distinctive interactions with the other ingredients of the compositions relative to carbomer. Indeed, the Board credited skilled testimony that a qualified artisan “would not have envisioned any incompatibilities in substituting” the gelling brokers.

It was this shut similarity in the substitution that authorized the selection disclosures to build a presumption of obviousness.   In its conclusion, the courtroom also notes that the mentioned presumption-of-obviousness is not any form of burden shifting. Instead, it is basically shorthand for the proposition that overlapping ranges in the prior art justify a factfinder in concluding that the claimed variety was  recognized in the artwork.  The patentee is cost-free to supply proof displaying why its unique array is meaningful and thus non-clear in the deal with of a identical disclosure vary in the prior art.

Detrimental Limitation: The statements expressly exclude adapalene from the formulation. “[W]herein the … composition does not comprise adapalene.”  The crucial prior artwork reference (Garrett) does not even point out adapalene, and so, in accordance to the patentee, we are still left questioning whether Garrett may involve the material.  The Board turned down that argument as did the Federal Circuit.  In specific, the court restated its prior precedent that unfavorable limitations need not be expressly mentioned in the prior art.  “[A] reference will need not condition a feature’s absence in order to disclose a detrimental limitation.” AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358 (Fed. Cir. 2019).

Affordable Expectation of Achievements: Ultimately, the Court found that the Board had thoroughly discovered good reasons to incorporate the references.  In certain, the patent challenger delivered evidence that gelling compounds were efficient and compatible substitutes. As such, the substitution of A/SA was a “predictable layout option.”  This falls in the Supreme Court’s direction from KSR: “when a patent claims a structure previously identified in the prior artwork that is altered by the mere substitution of a person factor for one more known in the subject, the mix should do additional than yield a predictable outcome.”

The courtroom also areas significant pounds on irrespective of whether the substitution would have “a acceptable expectation of good results.”  Listed here, even though, professional testimony was supplied pertaining to their interchangeability.  Further more, [a] acquiring of a reasonable expectation of accomplishment does not call for absolute predictability of results.”



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