In my view, Obviousness is the most fundamental of patent law doctrines, and certainly much of the work of patent attorneys is to convince patent examiners that the claims are not obvious.
An every day part of patent practice is arguing about whether a cited prior art reference teaches a particular claim limitation. That analysis is not always an easy task because prior art is often quite cryptic as are the patent claims being evaluated. One way to look at the process is an interpreting of the prior art to see if it teaches the claim. In that form, the process is seen a question of fact that must be based upon substantial evidence and reviewed with deference on appeal. Tribunals also often use an alternative approach that involves a question of law reviewed de novo on appeal. In the alternative approach, the patent claim is interpreted to see whether it covers the the prior art in the process known as claim construction. The difference between these two approaches is subtle, but often with huge results.
In its recent Roku decision, the Federal Circuit provides an example of these two approaches. Roku, Inc. v. Universal Electronics, 63 F.4th 1319 (Fed. Cir. 2023). The 2-1 majority decided to interpret the prior art to see whether it taught the claimed multiple “communication methods.” The court found value in “both sides of this factual question,” but ultimately gave deference to the Board’s conclusions. In her dissenting opinion, Judge Newman contended that the majority overlooked the established principle that the obviousness is a question of law that should be reviewed afresh, or ‘de novo’.
Universal Remote: In its IPR petition, Roku presented the prior art (“Chardon”) that described a universal remote control that uses two different types of communications codes (CEC and IR) in order to control various devices. Chardon includes a table with CEC and IR codes for each different type of action that might be needed. The patent at issue claims the use of “two different communication methods.” The panel majority endorsed the Board’s factual finding that a “listing of command codes does not teach or suggest a listing of communication methods.”
In its rehearing petition, Roku argues that the panel majority’s analysis conflicts the Supreme Court’s repeated statement that obviousness is a question of law. Rather, according to Roku, the majority’s treatment of obviousness as effectively a question of fact contravenes 150 years of precedent holding that obviousness is a question of law. This shift could have far-reaching “pernicious consequences.”
Roku’s bad-consequences argument centers on two main points. First, they assert that the majority’s approach could undermine the uniformity of obviousness jurisprudence. I.e., the Court is effectively deferring to lower tribunals on the question of obviousness. This, they contend, contradicts a key purpose of the Court’s exclusive patent jurisdiction, which is to ensure nationwide uniformity in patent law. It also undermines the requirement set out in KSR that the obviousness analysis must be made explicit.
Second, Roku suggests that the majority’s methodology could lead to undesirable substantive outcomes — allowing for patents on trivial distinctions from the prior art. Roku argues that such trivial advances should not warrant patent protection as they do not represent real innovation and can hinder progress. They also caution that the majority’s approach could lead to genuine inventions being deemed unpatentable if the Court simply affirms factual findings without conducting a de novo analysis of obviousness. The argument here is that the appellate court is in a better position to judge obviousness than the PTAB or a Jury.
In re Couvaras, 2023 WL 3984753 (Fed. Cir. June 14, 2023)
A prima facie obvious combination of prior art chemical compounds can sometimes be deemed nonobvious if the result of the combination is sufficiently surprising, such as when a combination of pharmaceutical active ingredients results in an unexpected synergy. See, e.g., Sanofi-Aventis Deutschland GmbH v. Glenmark Pharms. Inc., USA, 748 F.3d 1354 (Fed. Cir. 2014). In a recent Federal Circuit decision, In re Couvaras, Judge Lourie (writing for a unanimous panel) explains the important distinction between unexpected results in a pharmaceutical combination product as opposed to the mere recitation of an unexpected mechanism of action.
The case is an appeal of a Patent Trial and Appeal Board decision affirming an Examiner’s rejection of the claims at issue as obvious. A representative claim recites:
11. A method of increasing prostacyclin release in systemic blood vessels of a human individual with essential hypertension to improve vasodilation, the method comprising the steps of:
providing a human individual expressing GABA-a receptors in systemic blood vessels due to essential hypertension;
providing a composition of a dosage of a GABA-a agonist and a dosage of an ARB combined into a deliverable form, the ARB being an Angiotensin II, type 1 receptor antagonist;
delivering the composition to the human individual’s circulatory system by co-administering the dosage of a GABA-a agonist and the dosage of the ARB to the human individual orally or via IV;
synergistically promoting increased release of prostacyclin by blockading angiotensin II in the human individual through the action of the dosage of the ARB to reduce GABA-a receptor inhibition due to angiotensin II presence during a period of time, and
activating the uninhibited GABA-a receptors through the action of the GABA-a agonist during the period of time; and
relaxing smooth muscle of the systemic blood vessels as a result of increased prostacyclin release.
Judge Lourie leads off the decision by observing that, while the claims at issue “literallyrecite methods of increasing prostacyclin release … by co-administering two well-known types of antihypertensive agents[, i]n reality, the claims relate to combatting hypertension with known antihypertensive agents and claiming their previously unappreciated mechanism of action.”
He then affirms the Board’s conclusion that it “is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” It was undisputed that the two types of active agents recited in the claims, GABA-a agonists and ARBs, were both known to be useful for alleviating hypertension.
The appellant, citing Honeywell International Inc. v. Mexichem Amanco Holdings S.A., 865 F.3d 1348, 1355 (Fed. Cir. 2017), argued that the mechanism of action recited in the claims, i.e., the increased release of prostacyclin, was unexpected, and that the Board had erred in dismissing the limitation as having no patentable weight due to inherency. But the Federal Circuit rejected this argument, noting that “Honeywell held that ‘unexpected properties may cause what may appear to be an obvious composition to be nonobvious,’ not that unexpected mechanisms of action must be found to make the known use of known compounds nonobvious.” The court agreed with the Board that the recitation of various mechanistic steps in the claims was insufficient to overcome the prima facie obviousness of the claimed methods, observing that:
While mechanisms of action may not always meet the most rigid standards for inherency, they are still simply results that naturally flow from the administration of a given compound or mixture of compounds. Reciting the mechanism for known compounds to yield a known result cannot overcome a prima facie case of obviousness, even if the nature of that mechanism is unexpected.
. . .
To establish unexpected results, Couvaras would have needed to show that the co-administration of a GABA-a agonist and an ARB provided an unexpected benefit, such as, e.g., better control of hypertension, less toxicity to patients, or the ability to use surprisingly low dosages. We agree with the Board that no such benefits have been shown, and therefore no evidence of unexpected results exist.
In CareDx v. Natera, an intriguing amicus brief was recently filed by the Honorable Paul Michel (Ret.) and Professor John Duffy in support of the patentee petitioners Stanford and CareDx. The brief advocates for the clarification of patent-eligibility law, and criticizes the Federal Circuit’s handling of the case. The filing of the brief has seemingly prompted the Supreme Court to request a response from the accused infringers, after they initially waived their right to do so. This move reflects some significance of the arguments presented in the brief. [Read the Brief]
According to Michel and Duffy, the Federal Circuit’s decision in the case overlooked the text of the Patent Act and conflicts with Supreme Court precedent such as Diehr and Cochran v. Deener. They argue that the decision fails to recognize the difference between patent eligibility (under § 101) and patentability (under §§ 102, 103, and 112). They further criticize the decision for an unduly simplified description of the invention that leaves out important details and for improper emphasis on “conventionality.” The concept of “conventionality” is more appropriately associated with issues of novelty and nonobviousness, as regulated by §§ 102 and 103 respectively, rather than being a key criterion for patent eligibility under § 101.
The brief spends some amount of time focusing on landmark patent cases such as Diehr and Cochrane v. Deener (while rejecting Flook) to illustrate how a process can be patent eligible despite encompassing conventional elements. And, throughout this argues that the Federal Circuit misunderstood the definition of “process,” which under 35 U.S.C. § 100(b) is defined to include “a new use of a known process.” The brief contends that this definition permits patents on new applications or improvements of known technologies, and that such improvements should be presumed to be patent eligible. But, the Federal Circuit’s eligibility criteria of “conventionality” prohibits this interpretation even though not rooted in the Patent Act’s text or the Supreme Court’s precedent.
As with other recent eligibility briefs, this one also underscores a need to address confusion and uncertainty surrounding patent eligibility, particularly in relation to biomedical and diagnostic patents.
Now that we’re almost to June, the petition is unlikely to be decided before the recess and instead will be held-over until the fall 2023 before we get a decision on whether the court will grant certiorari.
The “analogous arts” test is used in patent law to determine whether a particular reference is relevant for the purposes of an obviousness analysis. Under this two prong test, a reference is relevant if it is from the same field of endeavor as the invention at issue, or if it is reasonably pertinent to the problem the invention is trying to solve. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004)
In its 2007 KSR v. Teleflex decision, the Supreme Court ruled that the obviousness analysis should be more flexible and not confined to rigid rules or tests. Rather, KSR emphasized an “expansive and flexible approach” to obviousness. While KSR did not directly address the analogous arts test, it could be interpreted as calling for a more flexible approach allowing courts and the PTO more leeway to consider prior art from a broader range of sources as being “analogous” or “reasonably pertinent,” which in principle should make it easier for challengers to invalidate patents.
In inter partes review (IPR) proceedings, the Patent Trial and Appeal Board (PTAB) has invalidated patents claims for obviousness based on cited prior art that the PTAB found to be analogous, and until now the Federal Circuit has consistently affirmed those decisions on appeal. Unwired Planet, LLC v. Google Inc., 841 F.3d 995 (Fed. Cir. 2016); Smartdoor Holdings, Inc. v. Edmit Indus., Inc., 707 F. App’x 705 (Fed. Cir. 2017); Toyota Motor Corp. v. Reactive Surfaces Ltd., LLP, 816 F. App’x 480 (Fed. Cir. 2020); CyWee Grp. Ltd. v. Google LLC, 847 F. App’x 910 (Fed. Cir. 2021); and Kamstrup A/S v. Axioma Metering UAB, 43 F.4th 1374 (Fed. Cir. 2022)).
On occasion, the PTAB has found cited prior art to be non-analogous, and thus irrelevant for purposes of the obviousness inquiry. The Federal has twice affirmed those decisions on appeal. Polygroup Ltd. MCO v. Willis Elec. Co., Ltd, 759 F. App’x 934 (Fed. Cir. 2019) and Broadcom Corp. v. Int’l Trade Comm’n, 28 F.4th 240 (Fed. Cir. 2022)). In one reported decision, Donner Tech., LLC v. Pro Stage Gear, LLC, 979 F.3d 1353 (Fed. Cir. 2020), the Federal Circuit vacated and remanded after concluding that the Board had applied the wrong standard when it determined that a cited prior art reference was not analogous art.
On May 9, in Sanofi-Aventis Deutschland GmbH v. Mylan Pharms. Inc., the Federal Circuit held for the first time (to the best of my knowledge) that the PTAB erred in finding cited prior art to be analogous in an IPR. Significantly, the Federal Circuit’s decision did not address the merits of the analogous art question, but instead was based entirely on the fact that the patent challenger (Mylan) had failed to allege that the cited prior art was analogous to the challenged patent (U.S. Patent No. RE47,614, which relates to pen injectors used for the delivery of drugs such as insulin).
The court observed that:
A petitioner is not required to anticipate and raise analogous art arguments in its petition; instead a petitioner can use its reply to “respond to arguments raised in the corresponding opposition, patent owner preliminary response, patent owner response, or decision on institution.” See 37 C.F.R. § 42.23. However, Mylan did not use its reply to explain how de Gennes is analogous to the ‘614 patent.
The court reversed the PTAB’s finding of nonobviousness because it had relied upon a finding that the de Gennes reference was analogous prior art, but Mylan had never made the required analogous art argument. Mylan argued on appeal that it had, in its IPR petition, effectively argued that the de Gennes reference was analogous to another other cited prior art reference, i.e., Burren, and that Burren and the challenged Sanofi patent address the “same problem.” However, the court found Mylan’s arguments as to Burren insufficient to carry its burden because they did not directly address the challenged patent.
The court explained that:
In evaluating whether a reference is analogous, we have consistently held that a patent challenger must compare the reference to the challenged patent. This conclusion is reinforced by the purpose of the analogous art test, which is to examine whether a reference can be considered as prior art to the challenged patent in the first place. [The] purpose of the “prior art” must be evaluated with reference to the inventor’s purported invention disclosed within the challenged patent.
In 2019, Amgen acquired worldwide rights to apremilast (OTEZLA) from Celgene $13.4 billion in cash, in connection with Celgene’s merger with Bristol-Myers Squibb. Apremilast was the only oral, non-biologic treatment for psoriasis and psoriatic arthritis, and in 2020 apremilast generated $2.2 billion for Amgen.
At the time Amgen’s acquired apremilast, Celgene was involved in Hatch-Waxman litigation with numerous generic challengers, including Sandoz. Celgene had asserted three of its 11 Orange Book-listed patents against Sandoz, and in 2020 Amgen was substituted as plaintiff.
The primary patent asserted is U. S. Patent 7,427,638, which is directed to pharmaceutical compositions comprising stereochemically pure apremilast. The original expiration date of this patent was in 2024, but the patent received a patent term extension of more than three years, resulting in an effective patent expiration date of February 16, 2028, according to the Orange Book.
Celgene also asserted U. S. Patent 7,893,101, which is directed to enantiomerically pure solid forms (e.g., crystalline polymorphic forms) of apremilast. This patent is due to expire December 9, 2023.
The third patent asserted by Celgene was U. S. Patent 10,092,541, directed to methods for treating a patient using dose titration of apremilast. According to the Orange Book, this patent was set to expire on May 29, 2034.
The district court found the claims of the ‘638 and ‘101 patents to be infringed and not invalid, and enjoined generic apremilast until the expiration of the ‘638 patent in February 2028. On appeal the Federal Circuit affirmed, an outcome that Amgen characterizes as a win.
On the other hand, the district court found the asserted claims of the ‘541 patent to be invalid for obviousness, which reportedly “pleased” Sandoz because the ruling “enables Sandoz to launch [its] generic apremilast product in the U. S. in 2028, six years prior to the expiry date of the latest-expiring Amgen patent asserted in litigation.” On appeal, the Federal Circuit affirmed with respect to the obviousness of the ‘541 patent.
Here is a brief overview of the court’s decision regarding the asserted obviousness of these patents.
The ‘638 patent claims apremilast, which is the stereochemically pure (+) enantiomer of a compound falls that within a class of molecules referred to as phosphodiesterase-4 (“PDE4”) inhibitors. Sandoz’s obviousness argument was based primarily upon a prior art Celgene patent, U. S. Patent 6,020,058, which includes an Example 12 that describes a racemic mixture containing apremilast, but that does not disclose the purified (+) enantiomer. The Federal Circuit found that the district court had not erred in holding that Sandoz had not proven that a skilled artisan would have had sufficient motivation to purify the (+) enantiomer from the racemic mixture disclosed in Example 12, nor that a skilled artisan would have had a reasonable expectation of success in resolving that mixture into its enantiomeric components, given the unpredictable nature of resolving racemic mixtures.
The Federal Circuit further found that the district court had not erred in its finding of strong objective indicia of nonobviousness, particularly given the unexpected potency of apremilast relative to the apremilast-containing racemic mixture disclosed in Example 12. The court credited testimony from a Celgene researcher listed as an inventor on the ‘638 patent, who noted a 20-fold difference in potency between apremilast alone and the racemic mixture, and stated that the inventors “didn’t expect a 20-fold difference in potency… Normally, if a racemate is a 50/50 mixture of two enantiomers, you might expect a two-fold difference in potency, all things being equal.” The district court also did not err in determining that apremilast satisfied a long felt need for an improved psoriasis treatment suitable for oral administration, that others in the field had tried and failed to develop other PDE4 inhibitors as drugs, and that there had been a degree of skepticism about the safety of apremilast because of its structural similarity to thalidomide, a drug notorious for its teratogenic effects in fetuses leading to severe and debilitating birth defects.
The issue with respect to the ‘101 patent was whether it could rely upon the filing date of a provisional application to which it claims priority. The ‘101 patent claims crystalline Form B of apremilast, and the provisional application includes an Example 2 which discloses a synthetic procedure for preparing apremilast. Although Example 2 does not explicitly disclose that the resulting apremilast has the Form B crystalline structure, Amgen provided the court with the results of over a dozen experiments following the procedure of Example 2, all of which resulted in crystalline Form B of apremilast, while Sandoz had provided no evidence to establish that Example 2 was capable of producing a crystalline Form other than Form B. Although the district court had based its holding on its conclusion that the provisional application inherently disclose crystalline Form B of apremilast, the Federal Circuit found that it did not need to reach the issue of inherent disclosure because the evidence established that Example 2 actually disclosed crystalline Form B of apremilast, albeit without specifically disclosing the crystal structure of the resulting product.
The ‘541 patent claimed a method of treating a patient with apremilast that basically involves starting with a relatively low dose and, over a course of days, gradually increasing the dosage to arrive at a full dosage which is significantly higher than the initial dosage, i.e., a dose-titration schedule. The court found this to be an obvious method, in view of prior art disclosing a similar dosage schedule. The Federal Circuit observed that, as a general matter, varying doses in response to the occurrence of side effects is well-known and obvious to the skilled artisan.
Jordan is a second-year law student at the University of Missouri and a registered patent agent. He has an extensive background in chemistry and food science.
Amgen markets apremilast, a phosphodiesterase-4 (“PDE4”) inhibitor, which is used for treating psoriasis and related conditions, under the brand name Otezla® which is covered by three patents, U.S. Patents 7,427,638, 7,893,101, and 10,092,541. Sandoz submitted an Abbreviated New Drug Application (“ANDA”) seeking approval market a generic version of apremilast. Celgene, the original plaintiff, brought this Hatch-Waxman suit, asserting that Sandoz’s generic product would infringe the ’638 and ’101 patents. The Federal Circuit affirms the district court’s findings on all issues raised.
Sandoz asserts that U.S. Patent 6,020,358 renders the Amgen patents obvious. The ’358 patent is the first U.S. patent describing a racemic mixture containing apremilast. Enantiomers detail the orientation of the molecule around a chiral center and can have vastly different therapeutic outcomes and clinical results between the (+) and (-) enantiomers, particularly thalidomide analogues. The critical difference between the ‘358 and ‘638 patents is the composition of the mixture:
The ’358 patent is a racemic mixture comprised of 50% of the (+) enantiomer of 2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4acetylaminoisoindoline-1,3-dione and 50% of the (-) enantiomer.
Compare to an excerpt of Amgen’s language in claim three of ‘638:
A pharmaceutical composition comprising stereomerically pure (+)–2-[1-(3- ethoxy-4-methoxyphenyl)-2- methylsulfonylethyl]-4- acetylaminoisoindoline-1,3-dione, or a pharmaceutically acceptable salt, …
The ’638 Patent: Sandoz failed to provide clear and convincing evidence at the district court to show that a skilled artisan would have reasonably expected a benefit from separating the enantiomers or that the (+) enantiomer was the cause of the desirable properties of the ‘358 formulation. Sandoz’s appeal asserts that the district court erred in its findings.
At the Federal Circuit, Judge Lourie, writing for a unanimous panel of Judges Cunningham and Stark, focuses on the unexpected potency of apremilast discovered relative to the apremilast-containing racemic mixture during testing and experimentation. At the district court, the named inventor, Dr. Schafer, testified that the stereomerically pure apremilast reduces the production of tumor necrosis factor alpha (“TNFα”), the factor that is linked to psoriasis, 20 times more effectively than the previous patent.
Dr. Schafer also says that a skilled artisan would expect a twofold improvement in efficiency. The district court finds that the 20-fold difference, when an otherwise two-fold difference would have been expected by the skilled artisan was sufficient to support a finding of an unexpected result and subsequent nonobviousness. A 20-fold difference from the steromerically isolated formulation goes well beyond a difference in degree into a difference in kind.
It strikes me as interesting that the characteristics of apremilast were largely left undiscussed. Apremilast is a thalidomide analogue and safety concerns about the infamously teratogenic effects related to thalidomide were sufficient skepticism for a skilled artisan and the industry at large regarding stereomerically pure formulations. However, it would seem that this teratogenicity could cut both ways as a skilled artisan would have ample incentives to investigate the enantiomers separately for safety concerns in light of the thalidomide paradox.
The thalidomide paradox provides that racemic mixtures and pure enantiomers have different characteristics, despite in vivo racemization. If the molecule is sufficiently analogous to thalidomide, it seems that a skilled artisan would be inclined to be taught towards separating the enantiomers. Regardless, the unexpected result was found to be dispositive on appeal and the objective indicia weren’t necessary but the other findings of the objective indicia of long-felt need, others had tried and failed, industry skepticism, and commercial success were also affirmed.
The ’101 Patent: Sandoz also alleges that the ’101 patent should have been found to be obvious. Sandoz says the ‘101 patent should not be entitled to the priority date of March 2002 because the ’515 provisional application did not inherently disclose crystalline Form B of apremilast and therefore did not satisfy the written description requirements of 35 U.S.C. § 112. The district court relies on a finding that ‘515 application did inherently disclose the crystalline form.
The Federal Circuit did not find it necessary to delve into inherent disclosure because a review of the trial record shows Amgen provided multiple experiments, and expert testimony, showing that there was actual disclosure of the crystalline Form B. Absent any contrary evidence by Sandoz, the priority date and subsequent finding of nonobviousness were affirmed. Another win chalked up to Amgen’s excellent expert testimony.
The ’541 Patent: On cross-appeal, Amgen asserts that the district court finding that the patent is obvious in light of prior art is erroneous. The district court found that the ’541 patent would have been obvious over the prior art or in crediting expert testimony stating that dose-titration modification would have been routine to a skilled artisan. Specifically, dose titration would be something that is regularly done in the treatment of psoriasis.
Rotigotine is a drug used to treat Parkinson’s disease. People with Parkinson’s disease experience significant gastrointestinal dysfunction, such as difficulty swallowing, which can frustrate the oral administration of drugs. However, the complications associated with oral treatment can be avoided by means of a transdermal patch that delivers the drug through the patient’s skin. In order to cross the skin barrier, however, the drug must be in an “amorphous,” i.e., non-crystalline, form. If the drug crystallizes in the patch, it will generally not be able to cross the skin barrier.
In 2007, UCB invented and marketed “original Neupro,” a transdermal patch for the treatment of Parkinson’s disease containing a dispersion of amorphous rotigotine and polyvinylpyrrolidone (PVP), with the PVP functioning as a stabilizer. Unfortunately, soon after original Neupro entered the market it was found that the rotigotine was crystallizing when stored at room temperature, rendering the drug ineffective. This caused UCB to recall the product from the U.S. market in April 2008 (although it remained in limited use under a compassionate-use program). In Europe, regulators allowed original Neupro to stay on the market, under the condition that it would only be marketed under “cold-chain conditions,” i.e., it would be stored in a refrigerator.
The patent at issue in this case, U.S. Patent No. 10,130,589, is directed towards UCB’s solution to this problem, which was to essentially double the amount of PVP in the patch, from original Neupro’s weight ratio of rotigotine to PVP of 9:2 to the new, reformulated Neupro’s weight ratio of 9:4. In particular the ‘589 patent claims a method for stabilizing rotigotine by combining a non-crystalline form of rotigotine with PVP to form a solid dispersion, wherein the weight ratio of rotigotine to PVP is in a range from about 9:4 to 9:6. UCB re-entered the U. S. market with its reformulated Neupro in 2012.
In 2019, UCB sued Actavis for infringing the ‘589 patent in a Hatch-Waxman lawsuit. The district court found the asserted claims to be invalid based on anticipation and obviousness, particularly in view of earlier-issued UCB patents, i.e., the “Muller patents,” which disclosed combinations of rotigotine and PVP present at a range of weight ratios from 9:1.5 to 9.5. Note that the Muller patents cover both original Neupro (9:2) and reformulated Neupro (9:4), while the ‘589 patent (claiming a range of 9:4 to 9:6) only covers reformulated Neupro. Significantly, UCB had successfully asserted a Muller patent in a previous ANDA suit that resulted in an injunction preventing approval of Actavis’s ANDA until the relevant Muller patent’s expiration in March 2021. The ‘589 patent would not have expired until December 2030, and thus could have delayed FDA approval of a generic version of Neupro by nine additional years.
On appeal, the Federal Circuit reversed the district court’s anticipation ruling, but affirmed on the basis of obviousness. The opinion, authored by Judge Stoll, begins by explaining that Federal Circuit precedent sets forth an established framework for analyzing whether a prior art reference anticipates a claimed range. If the prior art discloses a point within the claimed range, the prior art anticipates the claim. On the other hand, if the prior art discloses an overlapping range, the prior art anticipates the claimed range “only if it describes the claimed range with sufficient specificity such that a reasonable factfinder could conclude there is no reasonable difference in how the inventions operate over the ranges.”
In the case at hand, the prior art Muller patents disclose a range (9:1.5 to 9.5) that overlaps with the range claimed in the ‘589 patent (9:4 to 9:6). The Federal Circuit found that the district court had erred by failing to analyze this as an overlapping range case, but to instead treat this as a case in which the prior art discloses a point within the claimed range. The Muller patents did not literally disclose any point within the range claimed in the ‘589 patent, but the district court had nonetheless concluded, based on expert testimony, that the range disclosed in the Muller patents would implicitly teach a person of skill “a few examples” of specific weight ratios, including 9:4 and 9:5 weight ratios of rotigotine to PVP. Nonetheless, the district court’s error with regard to its anticipation analysis was rendered moot when the Federal Circuit proceeded to affirm its obviousness finding.
Judge Stoll cited Federal Circuit precedent for the proposition that there is a presumption of obviousness when a claimed range overlaps with a range disclosed in the prior art. Although this presumption can be overcome if, e.g., the prior art teaches away from the claimed range, or the claimed range produces new and unexpected results, or other evidence demonstrates the nonobviousness of the claimed range, in this case the Federal Circuit agreed with the district court that UCB had failed to present evidence to rebut the presumption of obviousness.
For example, the district court had not erred in its decision to disregard the commercial success of reformulated Neupro, based on a lack of a nexus between the drug’s commercial success and the claimed invention. In particular, the Federal Circuit agreed that the existence of the Muller patents weakened UCB’s evidence of commercial success, because these patents operated as blocking patents, dissuading competitors from developing a rotigotine transdermal patch, at least until the Muller patents expired. While rejecting UCB’s suggestion that the court’s analysis had branded all co-owned patents as “blocking” patents, the court noted that in this case UCB had held exclusive worldwide rights to rotigotine for all therapeutic indications since 1998, and that until the Muller patents expired Actavis had been enjoined from marketing a generic version of reformulated Neupro.
The pending Supreme Court case of Amgen v. Sanofi focuses on a broadly claimed genus and asks whether the disclosure is sufficiently detailed. The Federal Circuit’s recent UMN v. Gilead is the flip-side. Regents of the U. of Minnesota v. Gilead Scis., Inc., 2021-2168, — F.4th — (Fed. Cir. Mar. 6, 2023). UNM’s original disclosure is extremely broad with “laundry lists” of components that might be included in various combinations; while the later-added claim is directed to a more particular sub-genus combination. The court looked in vain for some indication in the specification as to why the claimed combination is important or particularly suggested. Here, they disclosed a large forest, but failed to disclose the tree that turned out to be valuable.
Going forward, a patentee might avoid this particular problem with some patent attorney tricks. Rather than listing all potential components for each functional group and generally suggesting their combination, an early-stage patentee might have its AI assistant provide a hypothetical example of each possible combination, one at a time. That situation would provide clear ipsis verbis disclosure and thus more likely survive a written description challenge.
= = =
Most U.S. patents assert priority to at least one prior patent application filing. The early filing date helps avoid would-be intervening and invalidating prior art. But, the right to priority is not automatic. In addition to the formal paperwork, the original application must sufficiently disclose the invention as claimed in the later patent. Sufficiency of disclosure is generally judged under 35 U.S.C. §112(a) with the doctrines of enablement and written description.
A patent that improperly claims priority is not automatically invalid. Rather, the priority filing date is rendered void and then we consider whether the invention was still novel and nonobvious as-of the later filing date. This setup also allows these disclosure issues to be considered during Inter Partes Review (IPR) proceedings that are statutorily limited to anticipation and obviousness grounds.
In Regents of the U. of Minnesota v. Gilead Scis., Inc., 2021-2168, — F.4th — (Fed. Cir. Mar. 6, 2023), the Federal Circuit faced the issue of whether the written description found in UMN’s priority applications supported the claims in the resulting US8815830 patent. Here, the ‘830 patent covers the drug sofosbuvir that has FDA approval for Hep-C treatment. Claim 1 does not simply cover sofosbuvir, but instead an entire genus of molecules that fit the general structure shown above and where functional groups R1 – R7 are further defined within the claim. For instance, “R3 is hydroxy … R5 is an amino acid …”
UMN’s initial patent application was a provisional filed back in 2004, followed by a PCT application in 2005, followed by a non-provisional application in 2007 and finally by another non-provisional application in 2013 that led to the ‘830 patent. In 2010, a Gilead patent application published (“Sofia”) that discloses the claimed invention. In this setup, UMN’s can disregard Sofia so long as it properly claimed priority to at least one of those earlier applications. But, if priority fails then the ‘830 patent is anticipated.
During the IPR, the Board sided with Gilead — concluding that the priority filings lacked sufficient written description and thus that the claims were invalid as anticipated. On appeal, the Federal Circuit has affirmed in an opinion by Judge Lourie and joined by Judges Dyk and Stoll.
The patent act requires a “written description of the invention” be submitted in the form of a patent specification. “Judicial gloss” explains this requirement has proving that the inventor “possessed the invention as claimed” at the time of filing. Written description issues most often arise in situations like this one where the patented claims were not found in the original filing documents; but rather were added later during prosecution.
The courts have been particularly hard on patentees seeking to claim coverage for a large genus of compounds. In that situation, it is typically a difficult endeavor for the patentee to literally enumerate all operable compounds covered by the claims. That level of disclosure is not required, but the patentee must describe “the outer limits of the genus” as well as “either a representative number of members of the genus or structural features common to the members of the genus, in either case with enough precision that a relevant artisan can visualize or recognize the members of the genus.” The court will also consider “blaze marks within the disclosure that guide attention to the claimed species or subgenus.” Slip Op., citing In re Ruschig, 379 F.2d 990 (CCPA 1967).
Ipsis verbis: I mentioned above that written description challenges are most often successful in situations where the claim scope has changed during prosecution. Claims that are found word-for-word in the original application (ipsis verbis) can still fail the written description requirement, but that result is much less likely. Here, UMN argued that the original provisional filing disclosed the eventual claim in ipsis verbis form — pointing to a combination of elements of provisional claims 1, 2, 13, 21, 22, 45, and 47 that collectively forming a substantial word-for-word recitation of claim 1 in the ‘830 patent. On appeal though the Federal Circuit found that combination of this disparate set of claims required a bit too much cleverness.
Following this maze-like path, each step providing multiple alternative paths, is not a written description of what might have been described if each of the optional steps had been set forth as the only option. This argument calls to mind what Yogi Berra, the Yankee catcher, was reported to have said: “when one comes to a fork in the road, take it.” That comment was notable because of its indeterminacy, its lack of direction. Similarly, here, all those optional choices do not define the intended result that is claim 1 of the ’830 patent.
Moreover, Minnesota’s argument is akin to that rejected in Fujikawa, where the applicant “persist[ed] in arguing that its proposed count [wa]s disclosed ipsis verbis in Wattanasin’s application.” Fujikawa v. Wattanasin, 93 F.3d 1559 (Fed. Cir. 1996). As the court explained in Fujikawa: “just because a moiety is listed as one possible choice for one position does not mean there is ipsis verbis support for every species or sub-genus that chooses that moiety. Were this the case, a ‘laundry list’ disclosure of every possible moiety for every possible position would constitute a written description of every species in the genus. This cannot be because such a disclosure would not ‘reasonably lead’ those skilled in the art to any particular species.”
Slip Op. I would argue that the Federal Circuit erred on this point. The UMN provisional application’s Claim 1 is directed to the same general molecule, but with much broader definitions for each of the functional group. Then, the subsequent provisional dependent claims (2, 13, 21, 22, 45, and 47) refine the scope of those functional groups in a manner that is identical to that eventually claimed in the ‘380 patent. Here, each of these dependent claims are defined as being dependent upon any of the prior claims. Thus, provisional dependent claim 47 seemingly includes the identical limitations found in the ‘830 patent claim 1. Yes, it is a little bit complicated, but so is chemistry.
It is not clear that my quibble would change the outcome of the case since ipsis verbis support does not necessarily result in sufficient written description.
= = =
The absence of ipsis verbis support is not fatal, so long as the original filings sufficiently show possession of the full scope of the claimed invention. In cases involving very broad disclosure (a forest), the courts look carefully for indications that for disclosure of the particular trees actually claimed. But, long lists of components are not sufficient. Rather, the suggestions – the “blaze marks” — must be clear. Here, the PTAB found the patentee had failed to provide that roadmap and, on appeal, the Federal Circuit affirmed on substantial evidence.
[T]he structures [disclosed in the provisional] are so extensive and varied that [they] encompasses a significantly larger genus than that claimed in the ’830 patent, are not sufficiently common to that of claim 1 of the ’830 patent to provide written description support.
Slip Op.
UMN made other arguments that were all rejected:
The PTAB should have made a credibility determination or other fact finding regarding expert testimony. On appeal though the Federal Circuit concluded that the PTAB is not required to address each and every side contention within its decision.
The PTAB previously issued a decision that is facially inconsistent with this case, and thus is acting in an arbitrary and capricious manner. On appeal, the court found no problem since the Board is not bound by prior panels.
As a state institution, UMN is immune from IPR challenges. UMN recognized that this argument was previously decided by the Federal Circuit. Further, UMN has already lost a case on this argument and so is not just bound by precedent but also collateral estoppel.
KEYnetik, Inc. v. Samsung Electronics Co. (Fed. Cir. 2023)
This short non-precedential opinion authored by Chief Judge Moore affirms a PTAB IPR obviousness finding. The case has one key sentence:
Normally, once the function to be performed by software has been identified, writing code to achieve that function is within the skill of the art.
Slip Op. This statement sits well with modernist design principles aptly stated by architect Louis Sullivan: “Form ever follows function.”
The patent challenger had provided expert testimony that software modifications needed to transform the prior art into the claimed invention would be “straightforward” and “simple.” Those statements were not backed-up with specific analysis showing exactly how the modifications would be done. However, the Federal Circuit concluded that these general conclusions combined with the implied judicial notice from above were sufficient to support the PTAB’s factual finding that PHOSITA would have “a reasonable expectation of success” in making the transformation.
Going back to the function-equals-structure statement from above: The court does not explain or particularly justify its factual conclusion other than to cite its own 1997 decision of Fonar Corp. v. Gen. Elec. Co., 107 F.3d 1543, 1549 (Fed. Cir. 1997). Fonar Corp. did not deal with obviousness, but instead was an appeal on the issue of best-mode disclosure under Section 112. The patentee had provided functions of the software in its disclosure but had not provided the computer code itself. On appeal, the Federal Circuit found that disclosure of the functionality was sufficient to satisfy best mode:
As a general rule, where software constitutes part of a best mode of carrying out an invention, description of such a best mode is satisfied by a disclosure of the functions of the software. This is because, normally, writing code for such software is within the skill of the art, not requiring undue experimentation, once its functions have been disclosed. It is well established that what is within the skill of the art need not be disclosed to satisfy the best mode requirement as long as that mode is described. Stating the functions of the best mode software satisfies that description test. We have so held previously and we so hold today.
Id. The Federal Circuit did not endeavor to work through its Section 112(f) jurisprudence where it has repeatedly held that disclosure of function is insufficient to satisfy the ‘structure’ requirements of that provision.
By Sarah Burstein, Professor of Law at Suffolk University Law School
LKQ Corporation v. GM Global Technology Operations LLC, No. 2021-2348 (submitted but not decided) (oral argument recording available here)
On December 5, 2022, the Federal Circuit heard oral arguments in two cases between LKQ and GM. In one of them, LKQ asked the court to rule that the current primary reference requirement for design patent obviousness, as stated in In re Rosen and Durling v. Spectrum Furniture is inconsistent with the Supreme Court’s decision in KSR v. Teleflex.
The panel did not seem convinced that it had the authority to overrule those prior panel decisions and at least one judge expressed doubt that KSR even applies to designs. But the issue is an important one and well worth discussing, even if the panel declines to address the issue in this case.
Under Federal Circuit case law, “the ultimate inquiry under section 103 is whether the claimed design would have been obvious to a designer of ordinary skill who designs articles of the type involved.” To this end, the Federal Circuit has created a two-part test. First, the court must identify a primary reference—“a something in existence, the design characteristics of which are basically the same as the claimed design.” If there is a proper primary reference, then “other ‘secondary’ references may be used to modify it to create a design that has the same overall visual appearance as the claimed design.” To qualify as a proper secondary reference, a design must be “so related [to the primary reference] that the appearance of certain ornamental features in one would suggest the application of those features to the other.”
The primary reference requirement comes from the CCPA case In re Rosen. These references are, therefore, sometimes referred to as “Rosen references.” Durling is perhaps the clearest statement of the Federal Circuit’s current § 103 test for designs, which incorporates the Rosen requirement.
There is certainly much to criticize about the Federal Circuit’s approach to § 103 and designs. For example, the “so related” language has a long pedigree but its meaning has never been particularly clear. And these days, it seems like the Federal Circuit hardly ever reaches step 2 of the Durling test because it has applied such a high standard of visual similarity for the first step that it sometimes seems hard to see any blue sky between a design that looks “basically the same” (and is, therefore, a proper Rosen reference) and one that is “the same” (and thus anticipates the claimed design).
As currently applied, the Durling test—and in particular the Rosen reference requirement—seems to be just as rigid, if not more so, as the TSM approach the Supreme Court rejected in KSR. But does that mean the Rosen requirement is the problem? Or is the problem the way it is being applied?
As I wrote in my very first design patent article, “[t]he primary reference requirement performs the valuable function of focusing the nonobviousness inquiry on the design ‘as a whole.’ If a new design is so different from other products of its type that no primary reference can be found, that would generally be strong evidence of nonobviousness.” I continue to believe that, properly and flexibly applied, this general approach makes sense for designs and is consistent with KSR. (If you’d like to read more, you can find those arguments here.)
Unmooring the § 103 inquiry from this primary reference requirement would allow challengers to pick and choose visual elements from the prior art to combine into “Frankenart.” The Frankenart approach would devolve the § 103 inquiry into whether a designer technically could have created the claimed design based on the prior art, as opposed to (the more proper question of) whether it would have been visually obvious to do so.
Yes, it’s true that challengers can effectively use a Frankenart approach in most utility patent cases. But a design patent covers a different type of invention that is claimed in a different way. It makes perfect sense to apply the general command of § 103 in a different way when it comes to designs.
It’s also worth noting that while the primary reference requirement looks different from how we do § 103 in most utility patent cases, it’s not totally without cognates. It is at least reasonably analogous to the “lead compound” approach used in some chemical cases.
To be clear, this is not to say that the Federal Circuit’s current § 103 case law is great. It’s not. The cases apply the proper primary reference requirement too strictly. And it’s not at all clear how Durling step two does or should work. But that doesn’t mean we should abandon the primary reference framework entirely.
George Washington University Law School Professor Dmitry Karshtedt has passed. Dmitry was a remarkable scholar, wonderful colleague, and incredible friend. We often had different ways of thinking about patent law, and I always hoped that some day we might have time to write something together. Sadly will never happen. The world was more with Dmitry and less without him.
Professor Karshtedt received an A.B from Harvard and a PhD from UC Berkeley, both in chemistry. After a few years working as a chemist for a semiconductor startup, he went to law school, receiving his JD from Stanford Law School in 2011. He worked for a short time at Wilson Sonsini in Palo Alto before clerking for Judge Kimberly Moore on the Federal Circuit. He joined GW Law in 2015 after a fellowship at Stanford and received tenure in 2020.
Professor Karshtedt’s work was wide-ranging. He is named as an inventor on 13 patents, is the first-named author on five scientific publications, and spoke at dozens of conferences and presentations. His legal scholarship was deep and contemplative, and includes two articles published in the Iowa Law Review. His most recent work with Mark Lemley and Sean Seymore, The Death of the Genus Claim, 35 Harv. J. L. & Tech., is cited extensively in petitions for certiorari before the Supreme Court.
But more importantly, Dmitry was a wonderful colleague who contributed to every conference and workshop he attended. If you emailed him anything, whether a short question or a draft paper, he would always reply with a thoughtful response, including in depth comments on your work–comments that always made it better. I and many others had many wonderful conversations with Dmitry both over email and in person. I cannot speak personally about his teaching, but if it was any reflection of his professional interactions it must also have been terrific.
I have so many memories of Professor Karshtedt, but for now will end with a link to a PatentlyO guest post that he wrote just last year, in which he reconceptualized the framework for how courts should think about nonobviousness – an approach that will continue to influence my own thinking and make me sad for else might have been.
Zahner’s Design Pat. D746,078 covers the ornamental design of a shower curtain as shown in the figures above. Zahner sued Katri Sales for infringement, and the defendant turned-around and filed a request for ex parte reexamination. The examiner found some great prior art from 2013, which predates this particular design application filing date. But, the design patent also claimed priority to Zahner’s prior utility patent application (Serial No. 09/617,402) that predates the reference. The utility application includes a number of drawings that are similar-to, but not exactly the same as those in the Design Patent. (Images below).
The basic question in the case then was whether the priority drawings provide sufficient written description support for the eventual design as claimed.
09/617,402 (Priority filing)
The PTAB found the design claim was not sufficiently supported by the priority disclosure and so the priority claim was invalid. And, without the priority claim, the invention had become obvious by the time of the later actual filing date. The basic problem, can be seen in the design patent’s perspective view shown below. The perspective shows that the inner surface of the aperture is flat and with right-angled edges. According to the PTAB, those features are new to the design patent and not disclosed by Figure 21 of the priority filing. On appeal, the Federal Circuit affirmed without opinion.
Close-up of the Design Patent drawing
Zahner disagrees with the merits of the decision here, but has also suggested that it will raise procedural challenges in an upcoming petition for writ of certiorari. In particular, Zahner intents to raise the same question that Arthrex will likely raise, although this time in the reexamination context:
Question: Does the Reexamination Statute permit a challenge to priority claims?
Zahner has also argued that its situation is particularly egregious because the priority question was particularly addressed by the examiner during the original prosecution. That is important because reexaminations are limited to “new” questions of patentability.
After receiving the R.36 no-opinion affirmance, Zahner filed a petition for panel rehearing that included the following line: “A written opinion on this issue is respectfully requested.” The Federal Circuit though denied the petition without opinion. This situation thus raises the issue I addressed in my 2017 paper titled Wrongly Affirmed without Opinion. In that paper, I argue that these no-opinion judgments are contrary to the statutory requirement of Section 144 requiring the court to issue an opinion in appeals from the PTO. Although this argument has been raised in dozens of cases, the court has not yet responded to the argument, and the peculiar procedural setup allows this status quo. In a recent request for extension of time, Zahner indicated to the Supreme Court that it also plans to raise the no-opinion question.
I mentioned Arthrex above, its petition to the Supreme Court will be due in November 2022. In its failed petition for rehearing on the IPR-priority issue, Arthrex asked the following question:
Whether 35 U.S.C. § 311(b)’s restriction “only on a ground that could be raised under section 102 or 103” permits IPR challenges that depend solely on compliance with the written description requirement of section 112.
Patent cases regularly involve expert testimony about the how a “person having ordinary skill in the art” (PHOSITA) might think. PHOSITA is the objective ‘reasonable person’ that serves as a reference point for most patent doctrines. Often, PHOSITA is particularly defined by some educational or experience level related to the particular area of technology. The intuition here is that someone very little experience is likely to see an incremental invention as patentable; while someone with a very-high level of skill might see the same incremental advance as obvious. See Innovention Toys, LLC v. MGA Entm’t, Inc., 637 F.3d 1314, 1323 (Fed. Cir. 2011) (“A less sophisticated level of skill generally favors a determination of nonobviousness . . . . while a higher level of skill favors the reverse.”). Although this intuition generally makes sense, most agree that particulars are fairly irrelevant.
One difficulty with patents is that the inventions often bridge two or more major educational areas. A good example of this is Best Medical Int’l., Inc. v. Elekta Inc., — 4th — (Fed. Cir. Aug 26, 2022). Best’s patents cover a method of optimizing a radiation beam for use in tumor targeting. US 7,015,490. The invention requires understanding of how radiation treatment works and its impact on tumor growth. In addition, the invention requires a substantial amount of computer programming to implement the particular algorithms.
In the IPR, the patentee introduced testimony from Daniel Chase who has been designing and running radiation plans for decades. One problem here, although Chase has been doing this work and has expertise in radiation therapy design and optimization, he is not a computer programmer.
The basic rule with experts testifying about PHOSITA appears to be that the experts need to personally be at or above PHOSITA level.
[W]here an issue calls for consideration of evidence from the perspective of one of ordinary skill in the art, it is contradictory to Rule 702 to allow a witness to testify on the issue who is not qualified as a technical expert in that art.
Sundance, Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1363 (Fed. Cir. 2008)
In Best Medical, the PTAB qualified Chase as an expert as to portions of the invention, but then highly discounted his testimony regarding obviousness of the computer programming aspects of the invention. On appeal, the Federal Circuit gave deference to the Board’s factual conclusion that PHOSITA would have computer programming experience and affirmed that conclusion.
= = =
Best Medical also includes a small but important mootness decision. In the case, the patentee caught itself in the eye of the needle. In particular, an issue became moot after the PTAB’s decision, but before it filed the notice of appeal. On appeal here, the Federal Circuit found that the decision stands cannot be appealed; and no Munsingwear vacatur.
We talked about the IPR above. In addition, the petitioners had also challenged the same patent via ex parte reexamination. In the reexam, Best Medical cancelled claim 1, but did so “without prejudice or disclaimer.” Claim 1 had also been challenged in the IPR and Best Medical asked the PTAB to also drop that claim — but the PTAB refused and instead issued its final written decision that Claim 1 was obvious. Why?: The reexam was still pending and Best Medical had not filed a statutory disclaimer as to claim 1. The Board explained that “Under SAS we still have to issue a ruling on that claim unless it’s actually disclaimed.” On appeal, the Federal Circuit found no problem with the Board’s approach: “We cannot say that the Board erred in addressing claim 1’s patentability under these circumstances.”
Ok if the Board had power to hold claim 1 obvious, then the patentee should have a right to appeal that decision. Right?-Wrong. The catch here is that the Reexam ended before the appeal here and Best Medical did not appeal claim 1. At that point, claim 1 was dead and gone and a moot point.
Why even appeal a claim that you cancelled? The patentee doesn’t want the claim back, but is concerned that the IPR decision regarding claim 1 could create some amount of res judicata that might later inhibit its ability to enforce similar claims. An examiner in a separate case with a claim similar to claim 1 has apparently already stated that she is “essentially bound by the Board’s reasoning” On appeal though the Federal Circuit found this reasoning insufficiently concrete to create standing. In particular, the court apparently doubted the examiner’s reasoning. “Indeed, we know of no cases that would apply collateral estoppel in these circumstances, nor has BMI cited any.” The court also concluded that potential collateral consequences are generally insufficient on their own to confer standing to appeal. Thus, the appeal on claim 1 is dismissed as moot.
To be clear, this still looks like a good outcome for the patentee because of the general approach to issue preclusion that “non-appealable issues and judgments are without preclusive effect.” SkyHawke Techs., LLC v. Deca Int’l Corp., 828 F.3d 1373 (Fed. Cir. 2016).
The Federal Circuit’s decision here is a bit squirrelly for those of you who know about the Munsingwear line of cases. US v. Munsingwear, Inc., 340 U.S. 36 (1950), involved charges of violating WWII era price regulations. The district court had dismissed the case on the merits. Meanwhile, while the case was on appeal, the President cancelled and annulled the regulation. This seemingly made the appeal moot–except for the potential collateral consequences. In its decision, the Supreme Court vacated the judgment below with instructions to dismiss the case.
That procedure clears the path for future relitigation of the issues between the parties and eliminates a judgment, review of which was prevented through happenstance. When that procedure is followed, the rights of all parties are preserved; none is prejudiced by a decision which in the statutory scheme was only preliminary.
Munsingwear. In Best Medical, the Federal Circuit distinguished Munsingwear based upon timing of the appeal. The apparent difference: In Munsingwear the case became moot after the notice of appeal had been filed. In Best Medical the case became moot before the notice of appeal.
We also hold that Munsingwear vacatur is inapplicable here because this appeal did not become moot during the pendency of the appeal. Rather, the “mooting” event— claim 1 being finally canceled—occurred before BMI filed its notice of appeal.
Slip Op. This final bit appears potentially wrong to me. The Federal Circuit does not cite any prior cases holding that Munsingwear does not apply to cases that become moot during that short window between a lower court’s final judgment and the filing of a notice of appeal. But, I have not seek a case on-point yet.
For our patent law course today, the students read the Justice O’Connor unanimous opinion in Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141 (1989).
Bonito Boats centers on a Florida statute prohibiting copying of unpatented boat hulls via direct molding. The Florida courts had refused to enforce the law because it conflicted with Federal Patent Law. And the Supreme Court affirmed — holding that the “carefully crafted bargain” embodied by the US patent system occupies the entire space and thus preempts any further state action offering patent-like rights.
From their inception, the federal patent laws have embodied a careful balance between the need to promote innovation and the recognition that imitation and refinement through imitation are both necessary to invention itself and the very lifeblood of a competitive economy.
Id. The “balance” recognized by the Court is that some innovations are patentable, but only under the strict requirements found in sections 101-112 of the Patent Act. And, once a patent expires (or is refused or forfeited by public use), the balance allows “free access to copy whatever the federal patent and copyright laws leave in the public domain.” Compco Corp. v. Day–Brite Lighting, Inc., 376 U.S. 234 (1964). In its analysis, the court had to contend with its prior statements permitting state regulation of trade secrets covering innovations that could have been patented. See Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470 (1974). The key difference is that the Boat Hull statute offered rights to inventions available to the public, while trade secret rights only apply information outside of public awareness. And, in addition the court noted that trade secrets protect a “most fundamental human right, that of privacy.” Id. In other words, there is a substantial state interest in protecting trade secrets that fall outside of the realm of the patent balance. Kewanee also made an assertion that trade secrets are so weak that they are unlikely to shift innovator activities. That final assertion has become dubious in my mind as trade secrets have become more important within certain industries, alongside the expansion of patent eligibility exclusions.
One reason we read Bonito Boats early in the semester is because of the way that O’Connor walks through the various patentability doctrines, explaining how each serves an important role in the patent balance.
The novelty requirement [operates] to exclude from consideration for patent protection knowledge that is already available to the public. [The provisions] express a congressional determination that the creation of a monopoly in such information would not only serve no socially useful purpose, but would in fact injure the public by removing existing knowledge from public use. . . . As the holding of Pennock makes clear, the federal patent scheme creates a limited opportunity to obtain a property right in an idea. Once an inventor has decided to lift the veil of secrecy from his work, he must choose the protection of a federal patent or the dedication of his idea to the public at large. As Judge Learned Hand once put it: “[I]t is a condition upon the inventor’s right to a patent that he shall not exploit his discovery competitively after it is ready for patenting; he must content himself with either secrecy or legal monopoly.” Metallizing Engineering Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d 516 (2nd Cir. 1946).
In addition to the requirements of novelty and utility, the federal patent law has long required that an innovation not be anticipated by the prior art in the field. Even if a particular combination of elements is “novel” in the literal sense of the term, it will not qualify for federal patent protection if its contours are so traced by the existing technology in the field that the “improvement is the work of the skillful mechanic, not that of the inventor.” Hotchkiss v. Greenwood, 11 How. 248 (1851). In 1952, Congress codified this judicially developed requirement in 35 U.S.C. § 103, which refuses protection to new developments where “the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person of ordinary skill in the art to which said subject matter pertains.” The nonobviousness requirement extends the field of unpatentable material beyond that which is known to the public under § 102, to include that which could readily be deduced from publicly available material by a person of ordinary skill in the pertinent field of endeavor. Taken together, the novelty and nonobviousness requirements express a congressional determination that the purposes behind the Patent Clause are best served by free competition and exploitation of either that which is already available to the public or that which may be readily discerned from publicly available material.
The applicant whose invention satisfies the requirements of novelty, nonobviousness, and utility, and who is willing to reveal to the public the substance of his discovery and “the best mode … of carrying out his invention,” 35 U.S.C. § 112, is granted “the right to exclude others from making, using, or selling the invention throughout the United States,” for a period of 17 years. 35 U.S.C. § 154. The federal patent system thus embodies a carefully crafted bargain for encouraging the creation and disclosure of new, useful, and nonobvious advances in technology and design in return for the exclusive right to practice the invention for a period of years.
Bonito Boats. Of course one interesting bit of the story that the SUpreme Court admits is that Congress was not fully aware of what it was doing throughout all this careful crafting.
The Bonito Boats decision continues to have important influence on state activities. For instance, in its 2020 Jackson decision, the Second Circuit applied Bonito Boats in the copyright context to hold that copyright law impliedly preempted a particular right of publicity claim made by Curtis Jackson, aka “50 Cent.” In re Jackson, 972 F.3d 25 (2d Cir. 2020). Jackson had sold his copyrights to his record label, but was attempting to use rights of publicity to effectively control reproduction of his works.
A few years ago I read a great series of fantasy books, The Wandering Inn. A key series storyline involves the protagonist meeting with ant-like Antinium and, through their interactions, transforming some of more computer-like hive members into individuals. The word individual is important for U.S. Patent Law, because the U.S. Patent Act was amended in 2011 to expressly require that inventors be “individuals.” 35 U.S.C. § 100(f) (2022). For Antinium, becoming individual meant breaking away from the hive-mind. In its newest decision on the topic, the Federal Circuit declares instead, for the purposes of patent law, an inventor must be human.
Here, there is no ambiguity: the Patent Act requires that inventors must be natural persons; that is, human beings.
Thaler v. Vidal, 2021-2347, 2022 WL 3130863 (Fed. Cir. Aug. 5, 2022). In the case, Thaler claims to own a computer named DABUS, and that DABUS conceived-of two patentable inventions. But, Thaler refused to claim credit as the inventor. And, the USPTO refused to issue a patent without a listed human inventor.
In my mind, it was always clear that the Federal Circuit would refuse Thaler’s petition, but it remains a fascinating topic in my mind. American legal personhood continues to ingenerate debate well beyond AI, including the contexts of legal fictions such as corporations, pre-birth human, and even non-human organisms (such as rivers). The result here shuts-down the debate – at least for the patent law concept of inventorship.
Of all the arguments presented, I thought that Thaler’s best relied upon Section 103’s statement that patentability shall not depend upon “the manner in which the invention was
made.” Thaler argued that the PTO was, in fact, refusing to issue a patent because the invention was made by an AI rather than a human. On appeal, the Federal Circuit held that provision should be limited only to apply to the obviousness context. “Section 103 is not about inventorship. Instead, it provides, in relevant part, that inventions may still be nonobvious even if they are discovered during ‘routine’ testing or experimentation.” Slip Op.
The court went on to expressly explain that it is only interpreting the words given by Congress. If someone wants to change the rules, the correct path is through legislation. Thaler will petition to the Supreme Court, but is unlikely to win.
* Thanks to Avery Welker for helping with this post.
One quirk of the Patent Act is Section 271(e), which creates infringement liability for simply seeking FDA approval to market a generic version of an already approved drug. 35 USC 271(e). Here, Actavis filed an Abbreviated New Drug Application (ANDA) seeking FDA approval to market a “liquid methylphenidate (MPH) oral suspension.” This is the same drug found in Ritalin and used to treat ADHD and other neurological concerns. This particular formulation is in liquid form and the active ingredient is designed for slow release. (Tris sells under the brand “Quillivant XR”). Tris responded to the Actavis ANDA by suing under 271(e) and asserting three separate patents.
271(e) actions are seen as a form of declaratory action similar to those taken by courts of equity prior to the merger of law and equity. As such, there is no Constitutional right to a jury trial in these cases and instead all issues of fact and law are typically determined by a federal district court judge.
The usual jury verdict just requires the ticking of an [X] invalidity box. Likewise, the Federal Circuit regularly decides its cases with by ticking the [X] affirmed without opinion box. The trick with bench trials though, is that the judge is required to explain its factual and legal conclusions. Fed. R. Civ. Pro. 52(a).
In an action tried on the facts without a jury or with an advisory jury, the court must find the facts specially and state its conclusions of law separately.
Id. Here, Judge Connolly (D.Del.) held a bench trial and original sided with the generic manufacturer–finding the asserted claims obvious. That original decision though was vacated by the Federal Circuit back in 2018 (the also panel slightly amended its decision in a 2019 rehearing order). In its decision, the Federal Circuit found that the district court had failed to explicitly and specifically consider a number of factual disputes and thus remanded for further findings:
[T]he district court failed to make the necessary factual findings and provide sufficient analysis of the parties’ arguments to permit effective appellate review. Specifically, the district court’s opinion merely recites the parties’ arguments but fails to explain or identify which arguments it credits or rejects. We thus cannot reach the merits of whether the Quillivant XR® formulation would have been obvious over the prior art. Rather, we identify gaps in the district court’s opinion and remand for the district court to conduct further factfindings and detailed analysis consistent with this opinion.
Tris Pharma, Inc. v. Actavis Lab’ys FL, Inc., 755 F. App’x 983 (Fed. Cir. 2018) (Tris I).
On remand, the district court accepted further briefing on the merits and then flipped the outcome–this time siding with the patentee. In particular, the district court held that “Actavis failed to prove by clear and convincing evidence that a person of ordinary skill in the art would have been motivated to combine the prior art references with a reasonable expectation of success.” On appeal here, the Federal Circuit has affirmed.
Claim 1 of Tris Pharma’s U.S. Patent Nos. 8,465,765 reads as follows:
1. A methylphenidate aqueous extended release oral suspension comprising (1) an immediate release methylphenidate component, (2) a sustained release methylphenidate component, and (3) water, said suspension having a pH of about 3.5 to about 5,
wherein said suspension provides a single mean average plasma concentration peak and a therapeutically effective plasma profile for about 12 hours for methylphenidate, and
wherein the suspension has a pharmacokinetic profile in which the single mean plasma concentration peak for methylphenidate has
an area under the curve (AUC)0->∞ of about 114 to about 180 ng-hr/mL,
Cmax of about 11 to about 17 ng/mL,
Tmax of about 4 to about 5.25 hours, and
T1/2 of about 5 to about 7 hours
following a single oral administration of said suspension at a dose equivalent to 60 mg racemic methylphenidate HCl in adults.
By the time Tris filed its patent application, several other methylphenidate oral formulations & extended release versions were already on the market, including Concerta, Daytrana, Focalin XR, Metadate CD, and Ritalin LA. As with most obviousness cases, the prior art taught all the claim limitations in various subsets, but no single reference disclosed an embodiment with all the limitations. And, the Federal Circuit agreed with the district court that the patent challenger had failed to show that PHOSITA would have a reasonable expectation of success when attempting to make any of the proffered combinations.
Without delving into the merits here, I only want to note the court’s focus on motivation-to-combine that is now regularly coupled with the requirement that the combination be based upon a “reasonable expectation of success.” The Federal Circuit (as well as lower courts and the USPTO) have increasingly used the “reasonable expectation of success” as a prong in the obviousness analysis. The chart below shows the number of Precedential Federal Circuit decisions that discuss a the Reasonable Expectation of Success test as part in the context of an Obviousness determination. As you can see, there was a substantial rise in its use beginning in 2006 during the lead-up to KSR (2007).
I’ll note also that this appears to be a case where forcing the tribunal to fully explain its decision ended up shifting the ultimate result.
In a divided opinion, the Federal Circuit rejected a PTAB non-obviousness decision–holding that “generic industry skepticism” is irrelevant to the question of obviousness. Auris Health, Inc. v. Intuitive Surgical Operations, Inc., 2021-1732, — F.4th —, 2022 WL 1275241 (Fed. Cir. Apr. 29, 2022). I suggest the Auris Health majority departs from KSR by again drawing sharp lines rather than allowing for a functional, flexible analysis. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The opinion was penned by Judge Prost and joined by Judge Dyk. Judge Reyna wrote in dissent.
The Intuitive Surgical patent is directed to a “method for performing robotic surgery.” The improvement is a servo-pulley mechanism for swapping surgical tools (e.g., scissors to scalpel to graspers). In 2018, Intuitive Surgical sued Auris Health for patent infringement. Intuitive Surgical Operations, Inc. v. Auris Health, Inc., No. 1:18-cv-01359 (D. Del.). In response, Auris petitioned for inter partes review. The PTAB instituted the IPR, but ultimately concluded in its final written decision that the claims had not been proven obvious. On appeal, the Federal Circuit has vacated and remanded.
The IPR focused on the combination of two prior art references: Smith and Faraz (US5624398 and US5824007) that collectively teach all of the claim limitations. Smith is directed to a robotic surgical system; and Faraz is directed to stand for holding surgical instruments. In its analysis, the PTAB considered evidence presented that (1) combining the two references would create some complications and (2) conventional wisdom established substantial skepticism regarding the use of robotic systems during surgery. Based upon this evidence, the PTAB concluded that a person of skill in the art would not have been motivated to combine the references in order to arrive at the claimed invention. On appeal, the Federal Circuit altered course–holding that “generic industry skepticism cannot, standing alone, preclude a finding of motivation to combine.”
There are two areas where skepticism might come into play: (1) as part of the KSR obviousness analysis considering reasons to combine references; and (2) as a secondary consideration of non-obviousness (aka objective indicia). In the second use-case (objective indicia), the Federal Circuit has previously tightened scope of relevant evidence to only those shown to have a tight nexus with the claimed invention. Here, however, the skepticism was tied to the particular claim elements, but rather was general skepticism shown to be held by persons of skill in the art “about performing robotic surgery in the first place.”
Here, the Federal Circuit has taken the nexus requirement used for secondary indicia and brought it forward to also apply when considering motivation-to-combine.
[W]hile specific evidence of industry skepticism related to a specific combination of references might contribute to finding a lack of motivation to combine, that’s not what we have here.
Auris Health. It seems to me that this approach is unduly restrictive and in tension with KSR’s rejection of “[r]igid preventative rules that deny factfinders recourse to common sense.” Rather, in KSR, the Supreme Court held that the question of whether a person of skill would combine references is a broad and flexible inquiry. Here, it appears that the Federal Circuit is asking for evidence relating to motivation-to-combine to be tied directly to the problem being solved. But KSR rejected that approach as well.
The Court of Appeals failed to recognize that the problem motivating the patentee may be only one of many addressed by the patent’s subject matter. . . . Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.
KSR. One question to consider here is whether the Supreme Court intended its analysis to by symmetrical or balanced. The Supreme Court talked about “reasons for combining” involving substantial flexibility, but did not discuss whether “reasons for not combining” should receive the same treatment. It seems obvious that this should be a balanced inquiry.
In his dissent, Judge Reyna agreed that “general skepticism toward robotic surgery” should ordinarily not be enough–by itself–to negate a motivation to combine. However, he argues that it should still may be relevant to the analysis. Here, Judge Reyna found that the Board had included this reason as one among many, and that substantial evidence thus supported the Board’s conclusion of no motivation to combine. (For example, the Board noted that the combination would restrict physician movement and would reduce surgical precision).
Judge Reyna also commented on the seeming rigid new rule:
I am also concerned that the majority opinion may reasonably be understood to announce an inflexible and rigid rule, namely that it is “impermissible” for the Board to consider evidence of artisans’ skepticism toward robotic surgery in determining motivation to combine. I find no authority for this assertion, and indeed it appears in tension, at a minimum, with the central thrust of KSR. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 415, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007) (rejecting the “rigid approach of the Court of Appeals” and articulating an “expansive and flexible approach” of determining obviousness). This is particularly true when considering art in fields of endeavor that are inherently dangerous or risky. Indeed, in past cases, this court has accounted for the attitudes of medical professionals toward certain types of procedures when determining whether a motivation to combine has been adequately demonstrated. See, e.g., Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1369 (Fed. Cir. 2012) (finding no motivation to combine where “doctors were not using the disclosed devices and methods to heal wounds with negative pressure because they did not believe that these devices were capable of such healing”).
Reyna in dissent.
= = =
What’s really happening here. In my view, the problem in this case comes down to the reality that the patentee’s evidence against combining the references is quite weak, and the majority disagreed with the PTAB’s conclusion giving it weight. However, since the court must give deference to PTAB factual findings, it would have been much harder challenge the decision on that ground, especially because the obviousness analysis depends upon so many factors. So, instead of challenging the factual findings, the majority decided to create a bright rule of law barring the evidence from even being considered as relevant to the inquiry.
By Sarah Burstein, Professor of Law at the University of Oklahoma College of Law
In December 2020, the USPTO put out a request for comments on “The Article of Manufacture Requirement.” (For prior PatentlyO coverage, see here.) Last week, at Design Day 2022, the USPTO announced that it had completed its summary of those comments. That summary is available here.
In the request for comments, the USPTO floated the idea of issuing design patents for what they are now calling “designs for projections, holograms, and virtual and augmented reality (PHVAR).” Presumably, this acronym is meant to suggest that these are new types of designs, uncontemplated by Congress when it passed statutes that—according to some—are in need of “modernization.”
But projected designs aren’t new.
As we explained in our law professor comments, designs for “magic lantern” projections go back at least as far as the 17th century. So the concept of projected designs was well-established by the time Congress passed the first design patent act in 1842—not to mention when it codified the Patent Act in 1952. Projected designs are simply not some new, unforeseen concept.
There may be new types of projection machines today, but this type of design is not new.
The USPTO suggests that the scope of design patentable subject matter “should be reevaluated in order to incentivize and protect innovation in new and emerging technologies.”
But it is not—and should not—be the role of the design patent system to incentivize or protect new machines. We have utility patents for that.
Furthermore, projected designs are not as the USPTO seems to suggest, unprotected today. Projected images qualify as pictorial, graphic, or audiovisual works that are already protected—costlessly and immediately upon fixation—by copyright. It can’t be seriously suggested that Congress was unaware of projected designs when it passed the broad definitions of protectable subject matter in the Copyright Act of 1976. It’s clear from the definitions that one form of projected creativity, cinema, was very much on Congress’ mind. See, e.g., 17 U.S.C. § 102(a)(6) (providing protection for “motion pictures and other audiovisual works.”).
Again, the type of projector may be new, but the type of work is not.
So why push for design patents when copyright is already available? There may be some who just want to accrue as many belts and suspenders as their IP budgets will allow. But that alone is not a good enough reason to expand design patentable subject matter.
It may be that, for at least some potential applicants, the goal is to avoid the requirements of copyright law. In Feist v. Rural, the Supreme Court held that a work must have “minimal creativity” to be protected. Thus, to gain copyright protection, a work must “possess some creative spark, ‘no matter how crude, humble or obvious’ it might be.” This is, according to the Supreme Court, a requirement of the Progress Clause.
Minimal creativity is a low bar. Yet the USPTO has granted numerous design patents for designs that fall below it—especially in the context of computer-generated designs. In theory, novelty and nonobviousness could be a higher bar but, in practice, that is not the case.
So let’s all be clear:
These are not new types of designs.
They’re not unprotected—unless they fail to meet the low constitutional threshold set in Feist.
The text of the Patent Act suggests that obviousness is a straightforward inquiry: find how the claimed invention differs from the prior art and ask whether, based upon those differences, an objective artisan would deem the invention obvious. 35 U.S.C. § 103. In reality, the analysis is not easy or straightforward. At the end of the day, tribunals are often left guessing whether the invention went far enough—are the differences from the prior art meaningful in some way or are they merely points of distinction. There are myriad ways that patentees endeavor to show results that are important, surprising, or synergistic—all terms that connote non-obviousness. One way to show meaning is through the use of what the Supreme Court has termed “secondary considerations” and others term “objective indicia.”
Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented. As indicia of obviousness or nonobviousness, these inquiries may have relevancy. See Note, Subtests of “Nonobviousness”: A Nontechnical Approach to Patent Validity, 112 U. Pa. L. Rev. 1169 (1964).
Graham v. John Deere Co., 383 U.S. 1 (1966). When courts ask about the importance of the advance, they must take care to ensure a nexus between the advance and its import. Focusing on the importance of the advance incentivizes advances that are important. Nexus is always relevant when considering if an advance is meaningful, but in recent years the Federal Circuit has aggressively used nexus particularly to limit the use of objective indicia such as industry praise or commercial success. Rather than permitting a fact to weigh the evidence, the court requires a proven nexus before any consideration of the objective indicia and its impact. Often industry praise and commercial success are tied to a commercial product rather than “the invention.” In this situation—where a product has been successful and praised—courts have permitted the patentee to prove a nexus linking the praise to the invention by pointing to the product and showing the product is an embodiment of the patent claim and the claimed invention is not merely a small component of the invention. In various formulations, the court has seen this as requiring the product to be “commensurate in scope” or “coextensive” with the claimed features. See Polaris Industries, Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1072 (Fed. Cir. 2018); Asyst Techs., Inc. v. Emtrak, Inc., 544 F.3d 1310, 1316 (Fed. Cir. 2008); In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983); Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d 1120, 1130 (Fed. Cir. 2000); Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). A difficulty with this formulary is that there are always unclaimed features found in any product, and so it is difficult to know when the two are “coextensive.” In its important 2019 Fox Factory decision, the Federal Circuit drew a hard line, requiring the product and claim be “essentially” identical:
Although we do not require the patentee to prove perfect correspondence to meet the coextensiveness requirement, what we do require is that the patentee demonstrate that the product is essentially the claimed invention. While coextensiveness is an issue of fact that should ordinarily be decided by the fact finder in the first instance, no reasonable fact finder could conclude, under the proper standard, that the X-Sync chainrings are coextensive with the patent claims.
Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366 (Fed. Cir. 2019) (citing to Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)). I wrote about Fox Factory back in 2019 and explained:
The court here again raised the “nexus” hurdle by holding that a presumption of nexus can only be achieved by proving that the product being sold by the patentee is “essentially the claimed invention.” This is a situation where SRAM owned two patents in the same patent family — both of which covered aspects of its X-Sync bicycle chainring (gear). Each patent included elements not claimed in the other — for the court that was enough evidence to disprove coexistence.
Dennis Crouch, Nexus: Product must be “Essentially the Claimed Invention”, Patently-O (December 18, 2019). Since the product in Fox Factory included multiple inventions—each covered by its own patent—the patentee was unable to show that any one of the inventions had nexus with the product. (Note here in Fox Factory, we are not talking about some complex invention – it was only a chain ring, i.e. a gear, that sold well).
An important en banc petition is pending before the Federal Circuit in Zaxcom, Inc. v. Lectrosonics, Inc., 20-1921 (Fed. Cir. 2022) involving that nexus and asking the Federal Circuit to reconsider its Fox Factory precedent. The setup in the case is fairly typical: Zaxcom sued Lectrosonics for patent infringement back in 2019 (D.New Mexico); Lectrosonics responded with two inter partes review petitions. The PTAB granted both IPR petitions and then cancelled the challenged claims as obvious. On appeal the Federal Circuit affirmed, and Zaxcom has now petitioned for en banc rehearing.
The Zaxcom inventions relate to a wireless method for multi-track video recording. The problem with wireless was always timing, and the inventions here solve that with very particular time-codes. The invention here was said to change the industry, and the inventors were awarded both an Emmy and an Oscar. Here is the deal, the invention is embodied in the product, and the praise was tied to the new functionality offered. But, the invention also includes features claimed in a different patent. Because of that, the Board found no nexus and refused to consider the Emmy/Oscar results based upon Fox Factory. On appeal, the Federal Circuit affirmed. The petition now asks for reconsideration of Fox Factory and its progeny:
By deviating from established law, the Fox Factory panel precedent has triggered a need for en banc review. This Court has warned against unduly “strict requirements” in evaluating nexus. Rambus. Nowhere is the wisdom of this warning more apparent than in the present case. Here, it is undisputed that products embodying the claimed invention (Zaxcom’s wireless audio recording system) received industry praise, including a technical Oscar and an Emmy. Lectrosonics did not contend that the claimed invention is just a “small component” of this system. Under this pre-Fox Factory standard, this entitles Zaxcom to a presumption of nexus. Yet the Board and the panel not only rejected this presumption but quixotically failed to find that the claimed invention received any industry praise, because they found that another feature contributed to the praise but was not required by the claims. Put another way, the decisions below disregarded the fact that products embodying the claimed invention undisputedly received the equivalent of not just one Nobel Prize in its field, but two.
What started as a relatively straightforward evidentiary presumption to facilitate the obviousness analysis under 35 U.S.C. § 103 has now morphed into a complex analysis “requir[ing] the fact finder to consider the unclaimed features of the stated products to determine their level of significance and their impact on the correspondence between the claim and the products.” Teva Pharms. Int’l GmbH v. Eli Lilly & Co., 8 F.4th 1349 (Fed. Cir. 2021) (citing Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1375 (Fed. Cir. 2019)). In addition to the new “level of significance” factor, recent cases have imposed an “essentially claimed” factor in the presumption analysis. See, e.g., Quanergy Sys., Inc. v. Velodyne Lidar USA, Inc., 24 F.4th 1406, 1418 (Fed. Cir. 2022). These new “requirements” of the presumption-of-nexus analysis conflict with this Court’s precedent.
Judge Michel brief. I expect responsive briefs from both the USPTO and the patent challenger Lectrosonics in late April 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.”
by Dennis Crouch
