Richard Treanor, Author at ElementIP Law

Recently we reviewed the USPTO’s published Examiner guidance concerning “the flexible approach to determining obviousness that is required by KSR Int’l Co. v. Teleflex Inc. (KSR)” in which the Office instructed Examiners to avoid any type of formalistic or formulaic approach when providing a reason to modify the prior art in favor of relying on any possible source that “may, either implicitly or explicitly, provide reasons to combine or modify the prior art to determine that a claimed invention would have been obvious.” Unfortunately for applicants, this advice seems to have accurately captured the current sensibility of the Federal Circuit which, in Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258 (Fed. Cir. Apr. 1, 2024), recently openly admonished a District Court for using a “degree of rigidity” in its obviousness analysis that was foreclosed by KSR and, perhaps most devastatingly, for “ask[ing] the wrong questions about important aspects of the obviousness inquiry.”

In particular, and among the district court’s several identified errors, the Federal Circuit in Janssen found that the district court analyzed the prior art without giving the needed weight to the perspective of a person of ordinary skill in the art (POSA) who is “capable of deducing what references fairly suggest or employing ordinary creativity.” And instead of considering the prior art in context or in combination, the Federal Circuit criticized the district court’s consideration of each reference one-by-one, “identifying each difference or dissimilarity between an individual reference and the claims, but not fully assessing the teachings in toto” thereby yielding a “siloed and inflexible approach” that left insufficient room for consideration of how background knowledge in the art would have impacted a POSA’s understanding of, or motivation to modify, the primary references at issue.” This approach, in the view of the Federal Circuit, inflated the significance of “minor variations between the prior art and the claims,” leading to the district court’s erroneous conclusion of nonobviousness.

Given the general decorum typically surrounding court opinions, this level of direct and unfettered criticism can mean only one thing – that at least for the foreseeable future the USPTO guidelines got it right insofar as the Federal Circuit is concerned. As the Federal Circuit, citing KSR, emphasized in this case, “[a]ssessing obviousness is based on an ‘expansive and flexible approach’ that ‘need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ’.” Applicant beware.

On February 27, 2024, the USPTO published “updated guidance to provide a review of the flexible approach to determining obviousness that is required by KSR Int’l Co. v. Teleflex Inc. (KSR).” While these guidelines are “a matter of internal Office management” and do not constitute new rules or new law, going forward they can be expected to significantly influence how Examiners determine obviousness on a day-to-day basis.

Although the stated purpose of the guidelines refers to the 2007 KSR case, the updated guidance first emphasizes that the factual inquiries set forth in the much earlier Supreme Court decision in Graham v. John Deere (1966) continue to control the obviousness determination within the Office: the scope and content of the prior art; the differences between the prior art and the claims at issue; and the level of ordinary skill. Against this background, the obviousness or nonobviousness of the subject matter is determined in light of any so-called secondary considerations such as unexpected results, commercial success, long felt but unsolved needs, failure of others, etc. It is upon this established “Graham framework” that the Office then addresses the ways in which KSR and its Federal Circuit progeny influence this framework.

Here, the guidelines make it very clear that the Office views KSR and its progeny as mandating flexibility in the determination of obviousness, in two respects: “first with regard to the proper understanding of the scope of the prior art, and second with regard to appropriate reasons to modify the prior art.” As concerns the proper (i.e., flexible) understanding of the prior art, the guidelines emphasize that a person of ordinary skill is “a person of ordinary creativity, not an automaton” who has “common sense, which may be used to glean suggestions from the prior art that go beyond the primary purpose for which that prior art was produced” and to make “reasonable inferences” and “be able to fit the teachings of multiple patents together like pieces of a puzzle.” With regard to a flexible approach in providing a reason to modify the prior art the guidelines disavow any type of formalistic or formulaic approach, such as the teaching, suggestion, and motivation (TSM) test, in favor of any possible source that “may, either implicitly or explicitly, provide reasons to combine or modify the prior art to determine that a claimed invention would have been obvious” including market forces, design incentives, the interrelated teachings of multiple patents, any need or problem known in the field of endeavor at the time of invention and addressed by the patent, and the background knowledge, creativity, and common sense of the person of ordinary skill.

Finally, and in summing up, the guidelines note the requirement that the Examiner provide a “clear articulation of the reason(s) why the claimed invention would have been obvious,” warning that “common sense—whether to supply a motivation to combine or a missing limitation—cannot be used as a wholesale substitute for reasoned analysis and evidentiary support, especially when dealing with a limitation missing from the prior art references” and emphasizing that all relevant evidence, including objective indicia of nonobviousness, must be considered in making the obviousness determination.

On balance, these guidelines do not substantially change what we currently see from Examiners in the chemical arts, so why publish them now? Are we about to see an even more “flexible” approach to obviousness? We think (hope) not. Instead, we believe that these guidelines have been published to make the determination of obviousness more consistent throughout the various technical areas of the Office, including the mechanical and electrical arts where, in our limited experience, the amendments and rebuttal arguments necessary to overcome obviousness rejections are perhaps not as significant, or as convincing, as those necessary for success in the chemical arts.

In May of 2023 the U.S. Supreme Court in Amgen v. Sanofi unanimously found that claims drawn to any antibody that could 1) bind to at least two specified residues of a certain protein and 2) block the binding of the protein to a certain receptor by at least 80% were 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 Amgen the Supreme Court made it clear that claiming everything – an entire class – by only its 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.” The court also made it clear that only when this “general quality” is present may the specification then call for a reasonable amount of experimentation to make and use a patented invention.

The U.S. Patent and Trademark Office (USPTO) has recently issued Guidelines for assessing enablement in view of Amgen, setting forth the USPTO’s position. These Guidelines make it clear that the USPTO understands that the ruling in Amgen:

1) applies to all technologies and all types of claims, and

2) confirms that USPTO personnel should continue to use the several “factors” established in In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) when assessing enablement – i.e., when assessing whether only a “reasonable” amount of experimentation (Amgen, Supreme Court) or “undue amount” of experimentation (Wands, Federal Circuit) would be required to practice the full scope of the claims.

As a reminder, the Wands factors include, but are not limited to: (A) the breadth of the claims, (B) the nature of the invention, (C) the state of the prior art, (D) the level of one of ordinary skill, (E) the level of predictability in the art, (F) the amount of direction provided by the inventor, (G) the existence of working examples, and (H) the quantity of experimentation needed to make and use the invention based on the content of the disclosure.

In one sense, the USPTO has essentially said, regarding Amgen, that “there is nothing to see here.” On the other hand, however, Amgen can be seen as effectively putting an end to functional claiming in the absence of what will likely be claim-narrowing specification disclosure of “some general quality . . . running through” the functionally claimed class that gives it its “peculiar fitness for the particular purpose.” Thus, Amgen can be viewed as a “reigning in” of a claiming strategy typically used in the early and quickly developing stages of a new technology, when prior art is often unavailable to provide a moderating effect on claim scope.

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

Older Posts

Posts by Richard Treanor

Federal Circuit Emphasizes Flexible Approach to Obviousness Determination

The USPTO Revisits the Determination of Obviousness

Enablement Reconsidered: USPTO Guidance in view of Amgen v. Sanofi

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

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

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