Richard Treanor, Author at ElementIP Law

Recently, the U.S. Supreme Court in Amgen Inc. v. Sanofi, 598 U.S. ___ (May 18, 2023) spoke with one voice in finding claims drawn to any antibody that could do two things – 1.) bind to at least two specified residues of the protein PCSK9 and 2.) block the binding of PCSK9 to the low density lipoprotein receptor gene by at least 80% – invalid for lack of enablement. In doing so, the court found patentee’s 26 specific examples and two disclosed methods for finding other examples insufficient to enable “an entire class of things defined by their function.”

In its analysis the court first reviewed several famous historical U.S. patent cases including the telegraph invented by Morse and the lightbulb invented by Edison that in their view established the concept that claiming everything – an entire class – that provides a certain function is not allowed unless the specification “also discloses ‘some general quality . . . running through’ the class that gives it ‘a peculiar fitness for the particular purpose.’” Only when this general quality is present, the “specification may [then] call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art.”

In reviewing Amgen’s specification the Court found that it failed to identify the required “general quality . . . running through” the claimed class of antibodies that provided their “peculiar fitness” for their claimed functions, and found Amgen’s “roadmap” and “conservative substitution” methods to be “little more than two research assignments” amounting to random trial-and-error. For these reasons, the Court found the Amgen claims to be invalid as not enabled.

The Amgen case thus provides us with good guidance for enabling broad claims generally, and especially broad, functional claims – the importance of describing a “general quality” applicable to the claimed class that gives it a “peculiar fitness” for the claimed purpose.

Only time will tell, but how this case will be applied to traditional chemical cases will be interesting to watch. Will a well-defined chemical “core” be sufficient for a Markush group potentially including 500,000 members? Maybe, with the answer probably depending at least in part on how much “detailed” core there is, and its distinctiveness. Clearly, cores described as “A-B-C” with definitions and sub-definitions for each will face an uphill battle, and probably represent one end of the chemical spectrum (the difficult end) whereas a sterol core, even with several substituents, and many choices of substituents, probably represents the other end.

In the 1960s the Federal Circuit’s predecessor court, the Court of Customs and Patent Appeals (CCPA), established a “flavor” of anticipation that did not require an example – when a reference was so limited and specific in its disclosure that one of ordinary skill in the art was able to “at once envisage” the specific compound, method, etc., claimed, that claim was anticipated by the reference. On December 20, 2022, the Patent Trial and Appeal Board (PTAB) in Ex parte Mizushima (Appeal 2022-003863) extended this theory of anticipation to a secondary, academic use of an “envisioned” composition.

In Mizushima the claim was directed to a powdered coloring material comprising at least one pigment selected from three protein-based pigment candidates in combination with at least one of three chelating agents. The prior art cited described an academic study of the influence of temperature, pH, and preservatives on one of the claimed pigment candidates, all conducted in solution. Eight preservatives were used, one of which was a claimed chelating agent (citric acid), used in solution in a claimed weight ratio. In addition to the solution studies, the paper provided a microstructure analysis on dried solutions of the pigment with two of the preservatives – sugar, described as being known for stabilizing proteins, and salt.

In affirming the examiner’s rejection, the Board acknowledged that the reference failed to make a solid composition comprising the pigment and citric acid in the claimed amounts, but took the position that one of ordinary skill “would have readily recognized or inferred” such a solid composition as emanating from the described solution using citric acid given the description of dried solutions using sugar and salt.

Ex parte Mizushima thus extends traditional “Petering” anticipation, which typically arises when an examiner chooses a combination of ingredients from a limited list to provide a claimed composition, to include different physical forms of ingredient combinations described in a reference for the purpose of academic study. That is, in a typical “Petering” situation the examiner constructs the anticipatory composition for the same reason the inventors did – to cure a disease, to treat a surface, to add to gasoline, etc. Here, the only reason the authors dried two of their solutions was academic curiosity – to see how two of their preservatives coated the pigment. Would the Federal Circuit agree with the Board that academic curiosity is sufficient motivation for one of ordinary skill to “at once envisage” a new form of a described material?

Judges: Hastings, Colaianni, Kennedy

On June 21, 2022, the Federal Circuit decided Novartis Pharm. Corp. v. Accord Healthcare, Inc., No. 2021-1070 (Fed. Cir. June 21, 2022) finding that a negative limitation added during the course of prosecution was not supported by the original specification.

The claims in this case were originally directed to a method for treating multiple sclerosis by administering a certain “daily dosage” of the drug fingolimod to a patient. Importantly, a “daily dosage” was well known in the art to be different from a “loading dose,” which is a more concentrated dose typically given only once – at the initiation of treatment, and prior to the administration of daily dosages. During prosecution, a preliminary amendment was submitted in which the claims were amended to exclude the use of a loading dose. No support was cited for this amendment.

On rehearing, the Federal Circuit found that this negative limitation lacked written description support in the original specification, noting that the specification was completely silent regarding loading doses. The fact that the (prophetic) example did not use a loading dose was not helpful, according to the court, because it had not been shown that “a skilled artisan would understand the specification as inherently disclosing the negative limitation” for example by establishing “that in a particular field, the absence of mention of a limitation necessarily excluded that limitation.” Otherwise, the court noted, “[i]f silence were generally sufficient, all negative limitations would be supported by a silent specification.”

In Novartis, although the Federal Circuit reversed its prior decision and found the disputed limitation unsupported, the court mentioned all the usual forms of support for negative limitations (stated disadvantages; listed alternatives; etc.) and acknowledged the possibility that silence could also form the basis of support. This is an important reminder for the practitioner trying to distinguish a claim from the prior art – not everything at your disposal is before your eyes: “[w]hile a written description’s silence about a negative claim limitation is a useful and important clue and may often be dispositive, it is possible that the written description requirement may be satisfied when a skilled artisan would understand the specification as inherently disclosing the negative limitation.” Discussion of how the PTAB recently handled a similar can be found on our blog.

This summer the Supreme Court denied certiorari in (i.e., declined to review) American Axle & Mfg. Inc. v. Neapco Holdings LLC. To many patent practitioners in the U.S., American Axle represented both the best hope and the best opportunity for the court to clarify the unsettled state of the law regarding patent eligibility under 35 U.S.C. § 101 caused by its 2012 and 2014 decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., and Alice Corp. v. CLS Bank Int’l., which have led to findings of patent ineligibility for garage door openers, prenatal genetic testing, DNA primers for cancer genes, methods of treating pain, etc.

In Mayo and Alice, the Supreme Court established what has come to be criticized as an extraordinarily vague two-part test for patent eligibility that first asks whether the claims at issue are “directed to” a patent ineligible concept, such as an abstract idea, a law of nature, or a natural phenomenon. If the answer is “yes,” the Court then asks whether the claim’s elements, considered both individually and “as an ordered combination,” “transform the nature of the claim” into a patent-eligible application. Good luck!

American Axle represented, to many, the perfect chance for the Supreme Court to clarify the situation, with claims directed to a process for making an automobile driveshaft having been found by the Federal Circuit to be directed to a natural law, and therefore not eligible for patenting under 35 U.S.C. § 101. In denying rehearing en banc, an evenly split Federal Circuit had six judges agreeing to deny rehearing and an equal number of judges dissenting, these twelve judges producing no less than five separate opinions to articulate their divergent views, demonstrating for many observers the clear controversy existing within the Federal Circuit regarding the correct application of the Mayo/Alice test.

By asking the Supreme Court to clarify “the appropriate standard for determining whether a patent claim is ‘directed to’ a patent-ineligible concept,” and whether “patent eligibility (at each step of the Court’s two-step framework) is a question of law … or a question of fact…” the American Axle case sought to assist the Federal Circuit in its application of 35 U.S.C. § 101 and thereby provide the patent bar with clear guidance on this important issue. Unfortunately, the Supreme Court failed to take up the challenge.

Last December, in Modernatx, Inc. v. Arbutus Biopharma Corp., 18 F.4th 1364 (Fed. Cir. 2021), Moderna, in appealing their challenge to an Arbutus patent in an inter partes review, contended that the Board had erred in dismissing their case because it failed to apply a presumption of obviousness based on overlapping ranges in the prior art. While Moderna admitted that not all of the claimed ranges of the Arbutus components were explicitly disclosed in their cited art, they contended that the single missing range could be calculated based on the other ranges and on the “axiomatic” concept that the total of all components must be 100%. The Federal Circuit disagreed.

While the court acknowledged that it had, in the past, found that a presumption of obviousness exists “when the ranges of a claimed composition overlap the ranges disclosed in the prior art,” it found that, in this case, it was undisputed that a range for one of the components was not expressly “disclosed.” Recognizing that it was also true that the court had never affirmatively decided whether the presumption could apply in a case such as this, the court nevertheless declined to make that decision here “because this case turns on a narrower issue, specifically, Moderna’s failure to show that the overlapping range is actually taught by the prior art.”

In dismissing Moderna’s seemingly reasonable theory of overlapping ranges using a calculated missing range the court found that “[o]ne of the key flawed assumptions that Moderna makes is that the amount of each individual … component in the prior art … can be freely manipulated and adjusted across the full scope of the disclosed ranges” and that, as a corollary, Moderna “assumes that any … component … can be increased as long as any … component … is decreased by a corresponding amount to maintain a total of 100%.” The court came to this position because Arbutus had put forth a “plethora of evidence, including evidence from the prior art references as well as expert testimony” demonstrating that “this case is not that simple because the … components … are interdependent, … they interact with each other unpredictably” and “as a whole, rather than on any one component.” The court then reminded Moderna that even in prior cases with fully, explicitly disclosed overlapping ranges involving multiple components “we have held that evidence that the components interacted in an unpredictable or unexpected way could render the combination nonobvious,” emphasizing in the opinion that such earlier holdings apply even more strongly here, where Moderna’s assumptions necessary to derive the unstated/implicit overlapping range are themselves undermined by the unpredictable interactivity between the components.

Takeaway: Because a rejection involving overlapping ranges can give rise to a presumption of unpatentability which puts the burden of going forward on applicant/patentee, it must be vigorously contested. The several ways in which Arbutus “fought off” the presumption in the Moderna case provide an instructive framework for traversing such rejections.

Judges: LOURIE, O’MALLEY, and STOLL

On February 28, 2022, the Patent Trial and Appeal Board (PTAB) issued a decision in Ex parte Chen (Appeal 2021-001752) affirming an Examiner’s rejection of claims directed to a polyisocyanurate foam composition comprising a certain two-component blowing agent.

In making the rejection, the Examiner used the same technique used in Almirall, LLC v. Amneal Pharm., No. 2020-2331 (Fed. Cir. Mar. 14, 2022) (discussed here) – she applied a primary reference disclosing one of the claimed blowing agent components and combined it with a secondary reference disclosing an expansive laundry list of blowing agent components that partially overlapped with species described in the primary reference and which, importantly, included the claimed blowing agent component missing from the primary reference. In justifying the combination, the Examiner took the position that because all the blowing agent components in the laundry list were “interchangeable and equivalent” it would have been obvious to substitute one of the overlapping components in the primary reference with the missing component.

Applicant traversed the rejection in three different ways in their Brief. First, they argued that neither reference, on its own, rendered the claims obvious (never a good idea in an obviousness rejection based on two references). Next, they asserted that because the primary and secondary references focused on different types of blowing agents one of ordinary skill in the art would not have combined the references. And finally, they argued that the data submitted during prosecution showed unexpected synergy for their blowing agent composition at their claimed ratios.

The Board, in its decision affirming the Examiner, ignored the first argument, rejected the second argument as lacking evidence and support, and found the data submitted during prosecution to be insufficient because it did not show the beneficial trend asserted and was not commensurate in scope with the claims.

Takeaway: Unfortunately, and as we learned in our prior blog on Almirall, where Applicant went wrong in this case was in not fleshing out its non-combinability argument. The primary and secondary references did indeed focus on different types of blowing agents – saturated v. unsaturated. A declaration explaining why the co-blowing agents listed in each reference were specially tailored for use with only one of these types of agents, and an explanation why only the few overlapping agents could be used with both types, might well have overcome the rejection.

Judges: J. Robertson, M. Cashion, Jr., S. McGee

Last month, in Almirall, LLC v. Amneal Pharm., No. 2020-2331 (Fed. Cir. Mar. 14, 2022) the Federal Circuit affirmed the Board’s holding of obviousness in an inter partes review. In Almirall the main issue in the case was the absence, in the primary reference, of the claimed gelling agent.

Petitioner, in asserting obviousness, used a secondary reference that disclosed both the claimed gelling agent and the gelling agent of the primary reference in a “laundry list” of ten broad types, or classes, of gelling agent useful in the secondary reference. Importantly, Petitioner also included substantial expert testimony characterizing the claimed gelling agent and the gelling agent of the primary reference as being “closely related,” as capable of being “interchangeably used” in the claimed formulations “in the same concentration range,” that such a substitution was “routine and predictable,” and that one of ordinary skill in the art “would not have expected any incompatibilities.”

Patentee, unable to successfully counter this mountain of evidence, was left to argue at the margins, and focused on the non-overlapping concentration ranges of gelling agents used in the primary and secondary references. However, the Court was having none of it:

Ultimately, despite Almirall’s attempts to argue otherwise, this case does not depend on overlapping ranges. It is simply a case of substituting one known gelling agent for another. Each may be effective at a different concentration in different formulations, but that is just a property of the particular known material, subject to conventional experimentation.

Takeaway: The Almirall case is interesting because the initial “hook” that led to the finding of obviousness was one that Examiners use in rejecting claims all the time: a secondary reference with an expansive laundry list of agents that includes both the claimed agent and the agent of the primary reference. The difference between the inter partes review in Almirall and regular prosecution, however, is that during prosecution the Examiner simply alleges interchangeability based on the common listing, without more, while in Almirall Petitioner submitted substantial evidence regarding combinability, interchangeability, and expectation of success. The Almirall case thus provides applicants with a good example of the type of evidence, albeit in the reverse, to submit in traversing such rejections during prosecution.

Judges: Lourie, Chen, Cunningham

In the chemical arts, method claims can sometimes seem like an afterthought. Oftentimes presented simply to fill out a claim set, they generally play “second fiddle” to compound and composition claims, their second-class status being justified by the belief that they are more difficult to enforce. However, in many instances where the underlying agent is old, for example in second indication/new use cases, method claims play an important, even primary, role. Recently, in Univ. of Strathclyde v. Clear-Vu Lighting LLC, 2020-2243 (Fed. Cir. Nov. 4, 2021), the Federal Circuit reinforced not only the importance of method claims in such circumstances, but the importance of claiming the result of the method in such circumstances.

In Strathclyde, university researchers found that blue light of a certain wavelength could be used to inactivate methicillin-resistant Staphylococcus aureus (MRSA) bacteria, without the use of a photosensitizing agent. During prosecution, Strathclyde claimed not only the single step of their simple yet elegant method (exposing MRSA to certain light), but also the result of the method (inactivating MRSA):

1. A method for disinfecting … by inactivating … MRSA … comprising exposing the … [MRSA] to visible light without using a photosensitizer … and wherein a portion of the visible light that inactivates the … bacteria consists of wavelengths in the range 400-420 nm. . .

After issuance of the patent, Clear-Vu filed an IPR based on prior art that disclosed a series of experiments attempting to inactivate MRSA via exposure to the same blue light, both with and without photosensitizing agent, finding that the MRSA was not inactivated unless a photosensitizing agent was used. Clear-Vu argued that at least some of these experiments anticipated Strathclyde’s claims, because they exposed the same bacteria to the same light in the absence of photosensitizer.

The PTAB disagreed, finding Strathclyde’s “inactivating” claim language to be a limitation not provided by the reference. The PTAB did however find the claims unpatentable as obvious in view of a secondary reference showing that different bacteria could be inactivated using strong doses of blue light, the PTAB reasoning that it would have been obvious to increase light intensity/exposure time, etc., in experiments without photosensitizer, and that there would have been a reasonable expectation of success in inactivating MRSA by doing so.

On appeal, the Federal Circuit agreed with the PTAB’s finding of no anticipation, and did a “deep dive” into the references, finding first that neither reference showed bacteria being inactivated in the absence of photosensitizer, and second that prior art attempts at such photosensitizer-free inactivation failed. Because “the claims require that the inactivation is a result of exposing bacteria to 400–420 nm light without using a photosensitizer,” and because “failures [of prior art attempts] undermine a finding of a reasonable expectation of success” the court reversed the PTAB’s determination of obviousness and reinstated the claims.

Thus, in Strathclyde we see the importance of specifying the result of a method in the claim itself as an unavoidable limitation. Here, it preserved patentability whereas simply setting out the method’s single step (exposing MRSA to blue light), without more, would have provided a very different result. While including the result of a method may not always be necessary in an independent claim (for example in a claim with multiple or complicated steps) it is always good practice to have at least a dependent claim present specifying the method’s result should it become necessary during licensing or enforcement, or in an after-issuance challenge, to preserve validity.

Judges: Reyna, Clevenger, Stoll

Even a casual, unscientific survey of recent PTAB decisions shows a clear and unmistakable trend: shorter decisions, with little or no discussion of issues not specifically raised by Appellant. While those seeking review of an Examiner’s decision could, at one time, expect both an independent review of the underlying rejection as well as consideration of their arguments, the PTAB is now more likely to focus solely on, and respond only to, those issues raised in Appellant’s brief. Indeed, 20% of recent decisions in Tech Centers 1600 and 1700 included the following language:

We review the appealed rejections for error based upon the issues Appellant identifies, and in light of the arguments and evidence produced thereon. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010) (precedential), cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed. Cir. 2011) (“[I]t has long been the Board’s practice to require an applicant to identify the alleged error in the examiner’s rejections.”).

Whether this trend is due to an increased workload at the PTAB, represents an attempt to reduce pendency, or is caused by something else altogether doesn’t really matter. What matters is that Appellants recognize this new reality and respond to it.

Unfortunately, this means that Appeal Briefs may need to include secondary arguments that, at one time, might have been left out as being distracting. More importantly, however, it is imperative to include, wherever possible, those arguments that appear to be “in favor” at the PTAB (i.e., those arguments that appear regularly in cases where the Examiner is reversed), and to present them prominently.

Right now, the “in favor” argument for Appellants unquestionably is whether the prior art provides a reasonable expectation of success. We have written extensively about this in our blog (link, link, link, link, link), saw it at the end of last year at the Federal Circuit in Teva Pharm. U.S. v. Corcept Therapeutics, Inc., 2021-1360 (Fed. Cir. Dec. 7, 2021) (invalidating the claim requires proof of “a reasonable expectation of success in achieving the specific invention claimed”), and may soon see it addressed at the Supreme Court in Apotex Inc. v. Cephalon, Inc., where infringer Apotex, in their Writ of Certiorari, neatly summed up the doctrine’s current pro-applicant, pro-patentee, pro-validity understanding that an obvious-to-try approach is only sufficient to invalidate where there is a reasonable expectation of success:

[T]he Federal Circuit seems to believe that if there is any uncertainty about whether an obvious-to-try approach will succeed, that potentially compromises the motivation to try an obvious solution to a pressing problem, and therefore produces patent monopolies for what is obvious to try. Indeed, so ingrained has the motive-to-try-what-is-likely-to-succeed test now become in the Federal Circuit’s obviousness psyche, that the Federal Circuit now sometimes includes motivation as a fifth Graham factor.

Because a “no reasonable expectation of success” argument cuts against the establishment of a prima facie case, success on this issue does away with any need for a showing of unexpected results, which can sometimes be difficult to provide. Thus, until there is something to the contrary diminishing this doctrine’s current status, understanding, and application, best practice issue advocacy dictates that whenever a “no reasonable expectation of success” argument can be made, it should be made. Supporting such a position during prosecution with a Declaration makes ignoring it, and refuting it, very difficult for both the Examiner and the PTAB.

In Ex parte Watabe, No. 2020-005979 (P.T.A.B. Sep. 28, 2021), the Patent Trial and Appeal Board (PTAB) reversed an Examiner’s rejection of claims directed to a solar cell assembly comprising a recess having a particular flatness. The issue in the case, both on appeal and at the examiner level, was whether the applied prior art inherently possessed the necessary flatness.

During prosecution, the Examiner presented several technical reasons explaining why the claimed flatness was inherent in the prior art, including a detailed comparison of the process used in the prior art with that of the inventors and, citing MPEP 2112.01, invited Applicant to provide evidence showing that the prior art did not necessarily possess the claimed flatness feature. Applicant responded to both the first and final rejection with a detailed analysis of their own, only to be denied in favor of the Examiner’s analysis, necessitating appeal.

In its Appeal Brief, Applicant expanded (from 3 pages to 5 pages) its analysis, and expanded it even further in its Reply Brief (to 7 pages in length). In reversing the rejection, the PTAB accepted Applicant’s analysis as showing a difference in methodologies between the specification and the applied reference, and found this persuasive on the issue whether the reference necessarily possessed the claimed flatness (note that the PTAB often makes the opposite decision).

Takeaway: While Applicant eventually prevailed in this case, it was a close call – the PTAB accepted “attorney argument” as persuasive on inherency, seemingly focusing on methods of preparation rather than final products. Wouldn’t it have been easier to file a Declaration in response to the first rejection, making it clear that the reference did not possess the required flatness, thereby providing evidence that the Examiner could rely on (and had asked for)? In this case there was an interview, two responses, an Appeal Brief, and a Reply Brief. While ultimately successful, it seems as though prosecution could have been short-circuited very early in the process with the right Declaration.

Judges: B. Franklin, B. Range, D. Dennett

Older Posts

Posts by Richard Treanor

Big Claims, Big Trouble

“Petering” Anticipation Extended to Different Physical Form

Negative Limitations Must be Supported by Positive or Inherent Disclosure

Supreme Court Refuses to Address Patent Eligibility Uncertainty

Speaking of Overlapping Ranges…

Oh, and about that Laundry List…

Inclusion in “Laundry List” Supportive of Interchangeability

Method Claims: The Importance of Claiming the Result

Appeal Briefs: The Importance of Issue Advocacy

PTAB Accepts Attorney Argument as Persuasive on Inherency

USPTO Further Delays Non-DOCX Fee Until January 17, 2024

USPTO Further Delays Non-DOCX Fee Until June 30, 2023