Eli Lilly is not likely to think of the Circuit’s handling of its successful IPR as an “intimate moment,” given that the Circuit reversed a finding of invalidity of all of the claims of a patent directed against its Cialis ED product. In the Technology v. Huawei case, the panel ruled that even though the patentee might have prevailed in distinguishing the prior art by making the narrower patentability argument it presented on appeal, it made a different argument during prosecution of the patent so that is the argument to be considered in construing the claim. In Icon v. Strava, the Circuit sent another case back to the Board to explain in a more detailed fashion the reasoning behind its invalidation of some of the claims.
While not a precedential ruling, the Circuit also overturned a $533 million jury verdict in favor of Smartflash over Apple’s iTunes software.
Thanks to my colleague Micah Stolowitz for his help with this week’s report.
Los Angeles Biomedical Research Institute v. Eli Lilly – In a split decision, the Circuit vacates and remands a determination by the PTAB that all of the claims of a patent asserted against Lilly’s Cialis erectile dysfunction product are invalid as obvious. In dissent, Judge Newman says she would affirm the decision but because the majority disagrees, it should simply reverse the Board rather than remand the case since the record is fully developed, and a time-consuming remand will defeat the AIA’s goal of a prompt determination of validity issues.
The majority first determines that the patent is not entitled to the earlier filing date of a provisional patent application. For a patent to be entitled to an earlier priority date, each previous application in the chain must comply with the written description requirement of § 112(a). It is not enough that a disclosure in a parent application merely renders the later-claimed invention obvious; the disclosure must describe the claimed invention with all its limitations. The provisional application does not explicitly disclose a dosage of “up to 1.5 mg/kg/day,” so it does not provide an effective filing date.
Claim 1, the only independent claim, recites: A method comprising:
a) administering a cyclic guanosine 3’, 5’-monophosphate (cGMP) type 5 phos-phodiesterase (PDE5) inhibitor according to a continuous long-term regimen to an individual with at least one of a penile tunical fibrosis and corporal tissue fibrosis; and
b) arresting or regressing the at least one of the penile tunical fibrosis and corporal tissue fibrosis, wherein the PDE-5 inhibitor is administered at a dosage up to 1.5 mg/kg/day for not less than 45 days.
The panel rules that the broadest reasonable interpretation of the phrase “an individual with at least one of penile tunical fibrosis and corporal tissue fibrosis” is its plain meaning. The Board’s construction (“an individual having symptoms that may be associated with penile fibrosis, such as erectile dysfunction, but not that the patient be specifically diagnosed as having penile tunical fibrosis or corporal tissue fibrosis”) reads that limitation out of the claim. Because erectile dysfunction is merely a symptom that may be, but is not necessarily, associated with penile fibrosis, erectile dysfunction cannot be equated with tunical fibrosis and corporal tissue fibrosis. In addition to plain meaning, there is no support in either the specification, the prosecution history or the expert witness testimony for the Board’s construction.
The panel also disagrees with the Board’s conclusion that the phrase “arresting or regressing the at least one of a penile tunical fibrosis and corporal tissue fibrosis” should have no limiting role, but merely stating the intended result of administering a PDE5 inhibitor at a dosage of up to 1.5 mg/kg/day for at least 45 days. While not dispositive, it is significant that the phrase “arresting or regressing the penile fibrosis” is drafted as part of a separate step of the method, not as the preamble or introduction to a process carried out by the administration of the drug. The wherein clause sets forth the minimum duration supported by the disclosure (45 days) for the arrest or regression of fibrosis at a high dosage of the PDE-5 inhibitor. But the reference to a minimum duration period of 45 days says nothing about the efficacy of the method if a lower dosage of PDE5 inhibitor is administered. The majority therefore concludes that “arresting or regressing” the fibrosis adds an efficacy requirement that is not otherwise found in the claim.
The majority agrees with LAB that the Board’s findings are insufficient to establish obviousness under the correct construction of the phrases at issue. The Board held that the references rendered obvious the treatment of erectile dysfunction via the claimed method, but it did not determine whether those references showed that it would have been obvious to use long-term continuous treatment with a PDE5 inhibitor to treat individuals with penile fibrosis and to achieve the arrest or regression of that condition. Specifically, the Board found that Montorsi and Whitaker taught the treatment of erectile dysfunction, and that the combination of Montorsi, Whitaker, and Porst gave rise to a reasonable expectation of success in treating erectile dysfunction. What the Board did not do, however, was to find that those references taught treating a patient with penile tunical fibrosis or corporal tissue fibrosis. Nor did the Board find that those references provided the basis for a reasonable expectation of success in treating those conditions. As indicated above, the correct construction of the pertinent claim language requires more than simply treating erectile dysfunction.
In a separate opinion, the Circuit affirms the Board’s determination that there is no anticipation. According to the opinion: To anticipate, a reference must do more than “suggest” the claimed subject matter. Thus, the panel holds that substantial evidence supports the Board’s finding that the reference does not disclose the claimed treatment regimen with sufficient clarity to satisfy “the demanding standard for anticipation.”
Technology Properties Ltd. LLC v. Huawei Technologies Co – TPL sued a number of device manufacturers, contending that products manufactured by Nintendo, Samsung and LG infringed its patent, which claims ways for processors to adjust their speeds for maximum performance. The panel vacates the construction of “entire oscillator,” describing a clock (oscillator) in a microprocessor, and remands the case. Two disclaimers derived from the prosecution history were held to limit the “entire oscillator” term. In one case, the corresponding limitation was affirmed even though it was broader than necessary to overcome the rejection. In the other, the panel reverses and remands because the district court’s construction applied the disclaimer too broadly in view of the context of applicant’s remarks.
The claim at issue requires, among other things, “an entire oscillator disposed upon said integrated circuit substrate,” which refers to the variable-frequency CPU clock. The district court construed the term to mean “an oscillator located entirely on the same semiconductor substrate as the central processing unit that does not require a control signal and whose frequency is not fixed by any external crystal.” Defendants contend the second half of the construction is proper because the patentee disclaimed certain claim scope during prosecution to overcome rejections based on patents to Magar and Sheets.
Magar discloses a microprocessor having a clock generator circuit that relies on an external crystal. TPL argues the district court erred by limiting the “entire oscillator” to one “whose frequency is not fixed by any external crystal.” It distinguishes Magar by arguing (1) Magar requires an off-chip crystal oscillator, while the claim generates the CPU clock signal on-chip; (2) Magar’s only oscillator is the off-chip crystal that is input to CLOCK GEN, which is located on the same silicon substrate as the CPU; and (3) CLOCK GEN itself is not an oscillator because it simply takes the output of the off-chip crystal and modifies it to produce four derivative signals.
The panel holds that the argument TPL raises on appeal may have been sufficient to traverse the Magar rejection, but this is not the argument TPL presented during prosecution. Had those same arguments been made to the Patent Office, our construction may have been different because TPL likely disclaimed more than was necessary to overcome the rejection. When this happens, we hold patentees to the actual arguments made, not the arguments that could have been made.
While the Circuit describes this change in construction as “minor,” and “likely does not affect the outcome in this case,” because the parties stipulated to non-infringement under the district court’s construction, the proper course of action is for the panel to vacate and remand.
Icon Health and Fitness v. Strava, Inc. – The Circuit affirms the PTAB’s IPR determination of obviousness as to most of the claims of a patent directed to a portable system for retrieving exercise programs used in an exercise machine, but reverses that determination as to a few of the claims.
In its opinion, the panel considers Icon’s argument that the Examiner and the PTAB simply adopted the factual and legal conclusions reached by Strava’s technical expert, and failed to provide their own detailed analysis of the reasoning behind their conclusions. The panel reviews the patent claims in groups, noting first that it needed to look first to see if there was substantial evidence to support factual findings. In some instances, even though the expert rendered an opinion on the ultimate issue of obviousness, the panel explains that that does not constitute reversible error as long as other aspects of the expert declaration contain statements relating to factual findings. The opinion then proceeds to review the findings of the Board on the merits, evaluating whether the PTAB made factual findings with the requisite evidentiary basis and adequately explained its findings.
As to some of the claims, the panel concludes that neither the PTAB nor the Examiner made the requisite factual findings or provided adequate explanation. Specifically, the PTAB rejected some of Icon’s arguments by asserting only that Icon “merely restates previous arguments regarding contacts of the cradle as discussed above.” But the PTAB had never actually addressed those arguments above. The PTAB’s opinion thus contains no substantive discussion of the limitations at issue for those claims. Because the PTAB failed to comport with what these principles demand, the PTAB’s rejection of these claims must be vacated and the case remanded for additional PTAB findings and explanation.
The panel distinguishes the handling of other claims because the Examiner made his own factual findings. The PTAB did incorporate sections of the Examiner’s Right of Appeal Notice, but the Examiner’s factual findings have an adequate evidentiary basis. As to the adequacy of the Board’s explanation, the panel notes that it would be preferable for the PTAB to provide its own reasoned explanation, but the PTAB did incorporate the Examiner’s findings, which provide an adequate basis for the mere “combination of familiar elements.” This is sufficient, if minimally, to explain the connection between the Examiner’s factual findings and legal conclusion.
As to other claims, the PTAB merely stated that it was “not persuaded” by Icon’s arguments and that “the Examiner’s rejection was sufficiently supported by the record.” However, the PTAB made only vague references to the prior art when summarizing Icon’s arguments. At no point did the PTAB make explicit findings as to these elements or specify what aspects of the expert declarations it found persuasive. As with other claims, the PTAB never made factual findings with a basis in the record or provided the requisite explanation to support its findings for these claims. It merely summarized Icon’s arguments and stated that the “Examiner’s rejection was sufficiently supported by the record.” Citing the recent NuVasive case, the panel notes that the PTAB cannot satisfactorily make a factual finding and explain itself by merely “summarizing and rejecting arguments without explaining why it accepts the prevailing argument.”
Judge O’Malley concurs in part and dissents in part, writing separately because she believes that “remand is not the appropriate remedy in examination appeals in which the PTO has not carried its burden of establishing unpatentability.” Rather than simply vacate the PTAB’s findings with which the panel disagrees, she would reverse those findings.
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