Lack of Corroboration Caused Claim of Prior Invention to Fail

In Apto Miitors APS v. Kamstrup, [2017-1681] (April 17, 2018) the Federal Circuit affirmed the Board’s determination that U.S. Patent No. 8,893,559 was anticipated by Nielsen, U.S. Patent App. Pub. No. 2012/0006127, finding substantial evidence supported the Board’s finding that Apator failed to sufficiently corroborate the
inventor testimony of earlier conception.

An inventor can swear behind a reference by proving he conceived his invention before the effective filing date of the reference and was diligent in reducing his invention to practice after that date.  However, that when a party seeks to prove conception
through an inventor’s testimony the party must proffer evidence corroborating the inventor’s testimony.  The sufficiency of the proffered corroboration is determined
by a “rule of reason” analysis in which all pertinent evidence is examined, but even under the rule of reason analysis, the evidence of corroboration must not depend solely on the inventor himself.

The evidence of prior conception included emails sent by the inventor transmitting drawings and presentations, but the only identification of the attachments was by the inventor.  The Federal Circuit noted the catch-22 of corroboration: Apator attempts to corroborate the inventor’s testimony with the emails and the drawings, but the emails and drawings can only provide that corroboration with help from the inventor’s

The Federal Circuit concluded that a reasonable mind could conclude that Apator
failed to proffer evidence corroborating the inventor’s testimony regarding conception, and accordingly held that substantial evidence supports the Board’s finding
that Apator has not established prior conception.

Claim Covered at least the Depicted Enantiomer

In Sumitomo Dainippon Pharma Co., Ltd. v. Emcure Pharmaceuticals Limited, [2017-1798, 2017-1799, 2017-1800] (April 16, 2018) affirmed determination of infringement of the claim which depicted the enantiomer that was the active ingredient.   While the district court construed the claim as covering both enantiomers and mixtures thereof, the Federal Circuit said that it need not determine what else falls within the claim’s ambit to resolve the dispute.

The plain claim language and specification demonstrate that, at a minimum, the claim covers what it depicts, which suffices to resolve the parties’ dispute because Appellants conceded that the district court’s judgment can be affirmed if the claim at least covers the depicted enantiomer.   Noting a lack of anything in the claim language limiting its scope to a “racemate” or “racemic mixture,” or some indication in the specification
or prosecution history to the contrary, the Federal Circuit held that the plain and ordinary meaning of the claim covers at least the specific enantiomer depicted in the claim itself.

Hold the Mayo: Specific Method of Treatment for Specific Patients using a Specific Compound at Specific Doses to Achieve a Specific Outcome Is Patent-Eligible Subject matter

In Vanda Pharmaceuticals Inc. v. West-ward Pharmaceuticals International Limited, [2016-2707, 2016-2708] (April 16. 2018), the Federal Circuit affirmed the district court;s determination that claims 1–9, 11–13, and 16 of U.S. Patent 8,586,610 (infringed and not invalid.

The Federal Circuit noted that inducement can be found where there is evidence of active steps taken to encourage direct infringement, which can in turn be found in advertising an infringing use or instructing how to engage in an infringing use.  Thus ican be found where there is evidence of active steps taken to encourage
direct infringement, which can in turn be found in advertising an infringing use or instructing how to engage in an infringing use.  The Federal Circuit rejected West-ward’s argument that the proposed label was insufficient to find inducement, without an underlying direct infringer, because in an ANDA case infringement is statutorily defined as filing or amending the application, not by selling a product.

The Federal Circuit also found that the district court did not clearly err in finding that the proposed label recommends performance of all the claimed steps, finding that potential noninfringing uses do not preclude a finding of specific intent to induce infringement.

Regarding subject matter eligibility, the Federal Circuit rejected West-ward’s argument that the claims were similar to the the claims found patent ineligible in Mayo.  First, the claims in Mayo were not directed to a novel method of treating a disease. Instead, the claims were directed to a diagnostic method based on the relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.  This relation was a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.  in contrast, the Federal Circuit found the instant claims were directed to “a new way of using an existing drug” that is safer for patients.

Second, the Federal Circuit found that unlike the claim in Mayo, the present claims do not tie up the doctor’s subsequent treatment decision.  The claim in Mayo did not go beyond recognizing  a need to increase or decrease a dose — it could be infringed even if the doctor did not actually change the treatment.  In other words, the claim in Mayo did not involve using the natural relationship. In contrast, the claims in suit recite the steps of carrying out a dosage regimen based on the results of genetic testing.  Thus the claims do not broadly tie up the doctor’s subsequent treatment decisions.

The Federal Circuit analogized the case to CellzDirect, where the claims were not directed to an observation or detection, but to a method of preserving cells. There, the natural ability of the subject matter to undergo the process did not make the claim “directed to” that natural ability. The Federal Circuit also distinguished Myriad, where the court noted that method claims and patents on new applications of knowledge about particular  genes were not implicated by its decision, noting the claims fall squarely  within categories of claims not implicated by its decision.

The Federal Circuit concluded that the claims were directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome. They are different from Mayo because they recite more than the
a natural relationship; instead, they recite a method of treating patients based on this relationship.

The Federal Circuit affirmed that the district court clearly erred in finding that the  patent sufficiently discloses the claimed invention.

Finally, the Federal Circuit agreed that 35 U.S.C. § 271(e)(4) supports the injunctive relief granted by the district court.



Posted in 101

PTAB is not Bound by prior Litigation-Based Claim Constructions Provided They are Appropriately Considered

In Knowles Electronics. v. Iancu, [2016-1954] (April 6, 2018), the Federal Circuit affirmed the PTAB’s affirmance of the Examiner’s determination that claims 1–2, 5–6, 9, 11–12, 15–16, and 19 of U.S. Patent No. 8,018,049 were anticipated, and claims 21–23 and 25–26 would have been obvious.

The claims were directed to a silicon condenser microphone and manufacturing method.  Knowles argued that the PTAB erred by improperly construing “package,” including by failing to consider the Federal Circuit construction of package in a related patent, and by improperly relying on a new ground of rejection to sustain the Examiner’s obviousness findings.

The Federal Circuit noted that it has held that, in some circumstances, previous
judicial interpretations of a disputed claim term may be relevant to the PTAB’s later construction of that same disputed term. While the PTAB is not generally bound by a previous judicial interpretation of a disputed claim term does not mean that it has no obligation to acknowledge that interpretation or to assess whether it is consistent with the BRI.  The Federal Circuit found that the PTAB considered a previous interpretation of the term and properly determined its claim construction was consistent with the term’s BRI, and the PTAB adequately explained its adoption a claim construction
relative to the prior construction.

On the question of whether the Board relied upon a new ground of rejection, the Federal Circuit said that the PTAB is not limited to reciting and agreeing with the examiner’s rejection in haec verba, and can further explain the examiner’s rejection and thoroughly respond to an applicant’s argument. Knowles argued that the the PTAB’s finding regarding the motivation to combine, based upon the principles of operation of the references, does not appear anywhere in the Examiner’s decision.  However, after examining the decisions of the Examiner and the Board, the Federal Circuit found taht the PTAB’s rejection relied on the same reasons provided by the Examiner, albeit using slightly different verbiage.  The Federal Circuit noted that Knowles was given, and actually used its opportunity to respond to the theory of unpatentability before the Board.