Posts Tagged: "inherency"

Claimed inventions in issued patents must, of course, pass the statutorily required hurdles of novelty and non-obviousness. In the context of solid forms, there are particular nuances the practitioner should consider when formulating a strategy for obtaining such claims in the United States. This article touches upon novelty and obviousness matters which have arisen with solid-form patents and provides some food for thought on how to plan in advance to tackle these issues.

While the claims-in-suit had previously survived validity challenges in an inter partes review (IPR) proceeding at the Patent Trial and Appeal Board (PTAB) and in a District of Delaware case, Aly credited additional testimony and evidence in this case with leading Judge Pallmeyer towards finding that the claimed advance was inherent to the invention in the prior art. “In IPR, there’s a limited record so there’s not a lot of testing to examine, and two tests were submitted in the Delaware case,” Aly said. While that could have been enough, he noted that, in the Fresenius Kabi case, multiple companies had done more than 20 tests, all of which showed that the claimed advances were inherent to the stable product.

On Friday, June 1st, the Court of Appeals for the Federal Circuit issued a decision in In re: Durance striking down a decision by the Patent Trial and Appeal Board (PTAB) that affirmed a patent examiner’s obviousness rejection of a microwave vacuum-drying apparatus and associated method. The Federal Circuit panel consisting of Judges Alan Lourie, Jimmie Reyna and Raymond Chen…

An inherency rejection, whether it be inherent anticipation or inherent obviousness, can be extremely difficult to overcome. Indeed, at many times it seems there is a great deal of subjectivity weaved into an inherency rejection… Inherency was initially a doctrine rooted in anticipation, but has long since been applied to become applicable to obviousness rejections as well. What this means is this: Inherency may supply a missing claim limitation in either an obviousness rejection. See Par Pharmaceutical, Inc. v. TWi Pharmaceuticals, Inc., 773 F.3d 1186 (2014). However, the Federal Circuit has always been mindful that inherency in the context of an obviousness rejection must be carefully limited. There is “a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis…” Id.

The Federal Circuit reversed. Indeed, it found that the Board committed legal error by improperly relying on inherency to find obviousness and in its analysis of motivation to combine the references. The court found that the Board erred in relying on inherency to dismiss evidence showing unpredictability in the art in rejecting Honeywell’s argument that a skilled artisan would not have been motivated to combine the references with a reasonable expectation of success. It referred to an earlier opinion [citations omitted] to state that “the use of inherency in the context of obviousness must be carefully circumscribed because “[t]hat which may be inherent is not necessarily known” and that which is unknown cannot be obvious.”

At the Federal Circuit, Honeywell argued that the Board erred in (1) finding a motivation to combine the references with a reasonable expectation of success, (2) rejecting Honeywell’s objective evidence of patentability, and (3) relying on a new ground of rejection (Omure), without giving Honeywell notice and opportunity to respond. The Court found that the Board improperly relied on inherency to find the claims obvious and in its analysis of motivation to combine. First, the Board’s analysis was internally inconsistent. While finding that “the claimed combination’s stability/miscibility is an inherent property of HFO-123yf and cannot confer patentability, the Board also acknowledged that inherent properties must be considered if they demonstrate unexpected and nonobvious results.

Inherent obviousness cannot be based on what the inventor thought, and, in addition, the results in a particular case may not be inherently obvious depending on what was expected by a person of ordinary skill. The court pointed out “’the mere fact that a certain thing may result from a given set of circumstances is not sufficient’ to render the results inherent.” Millennium Pharmaceuticals, 2017 WL 3013204, at *6 (citations omitted by author). The court also held that it is never appropriate to consider “what the inventor intended when the experiment was performed,” even though Millennium “conceded as a matter of law that the ester is a ‘natural result’ of freeze-drying bortezomib with mannitol.” Id. Thus, hindsight reasoning should never be applied and, obviousness is “measured objectively in light of the prior art, as viewed by a person of ordinary skill in the invention.”

Although the distinction between inherency in obviousness and anticipation is sometimes blurred, the two concepts are quite different and a claim may be inherently anticipated without being inherently obvious.  This could happen if the missing and unknown limitation were to flow naturally from the teachings of the prior art, and yet not be predictedable… A major difference between having knowledge of the missing limitation versus not having it is that the knowledge can provide the motivation to combine prior art references. 

It is inappropriate for a trial court to discount material expert testimony so as to weigh the evidence in favor of a party seeking summary judgment. The presence of a genuine dispute precludes summary judgment in such cases. … Failure to disclose arguments concerning claims of a different scope in a different patent application was not inequitable conduct when differences were apparent to the Examiner.