Richard Treanor, Author at ElementIP Law

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

In attempting to overcome obviousness rejections, our initial focus often centers on the differences between the cited references and the claimed invention. We do this in the hope of finding reasons that, even when the references are combined, the claimed invention would not be taught (no prima facie case). When such reasons are not present, we then generally look for a lack of motivation to combine the references which, unfortunately, has lately become more and more difficult to establish. However, in August the Federal Circuit issued a decision in Eli Lilly & Co. v. Teva Pharm. Int’l GmbH, 2020-1876 (Fed. Cir. Aug. 16, 2021) reminding us that, even where there is motivation to combine references, and even when all the claim limitations are provided by the combination, there is a third, separate requirement that must be met in order to establish a prima facie case of obviousness – a reasonable expectation of success in accomplishing what is required by the claims must also be present.

The Eli Lilly decision was one of three decisions issued on the same day in related inter partes review proceedings between Eli Lilly and Teva concerning patents related to monoclonal antibodies useful for the treatment of headaches. Importantly, in Eli Lilly the court found the claims’ preamble statements of “intentional purpose” (i.e., treating headaches) to be limiting. Then, citing Novartis Pharm. Corp. v. W.-Ward Pharm. Int’l Ltd., 923 F.3d 1051 (Fed. Cir. 2019) and summarizing the holding in that case as finding that “it was not enough for the [defendant] to have shown that a skilled artisan would have pursued the claimed method as a treatment option, but the [defendant] also had to show that the skilled artisan would have reasonably expected to achieve success in the treatment,” the Federal Circuit affirmed the PTAB’s finding that Lilly had failed to establish a reasonable expectation of success in pursuing the claimed method due to the uncertain and unpredictable nature of the underlying technology, even though the applied references taught all the limitations of the contested claims, and even though there was motivation to combine the references.

The Eli Lilly case is thus a good reminder for patent practitioners that, even in the face of what appears to be a very good prima facie case, there may be a pathway to patentability through the “no reasonable expectation of success” route, especially in unpredictable/newly developing arts.

Judges: Lourie, Bryson, O’Malley

Recently, the Federal Circuit, in SRI Int’l v. Cisco Sys., 2020-1685 (Fed. Cir. Sep. 28, 2021), clarified the confusion caused by an earlier remand to the district court, in which the Federal Circuit instructed the district court to determine whether the infringer’s conduct met the “wanton, malicious, and bad-faith behavior required for willful infringement.” The district court, surprised by this instruction (as was the patent bar), nevertheless proceeded and found the infringer’s conduct insufficient to meet this new, heightened standard.

On appeal for the second time, the case returned to the same three-member panel of the Federal Circuit, which clarified that it was not their intent to create a heightened requirement for willful infringement and reiterated the standard for willful infringement summarized last year in Eko Brands, LLC v. Adrian Rivera Maynez Enters., Inc., 946 F.3d 1367 (Fed. Cir. 2020): “willfulness requires a jury to find no more than deliberate or intentional infringement.” Additionally, the Federal Circuit explained that the heightened standard originally cited in remanding the case to district court was meant to refer to conduct warranting enhanced damages, available after willfulness is established.

Thus, the test for willful infringement remains as it was formulated in the U.S. Supreme Court’s 2016 decision in Halo Elecs., Inc. v. Pulse Elecs., Inc., 136 S. Ct. 1923 (2016). Importantly, the Federal Circuit in SRI Int’l. left unchanged the common defense to willful infringement: obtaining an opinion of counsel confirming that an activity or product does not infringe a patent and/or confirming that a patent is invalid and/or unenforceable.

Judges: LOURIE, O’MALLEY, STOLL

In a decision helpful to companies involved in the formulation of generally known ingredients (e.g., lubricants, glass, shampoos, cosmetics, etc.), the PTAB in Ex parte DeGeorge recently overturned an Examiner’s “kitchen sink” rejection based on the combination of two references, one of which listed six of Applicant’s required seven claimed components, all of them optional.

In DeGeorge the Examiner made a typical “kitchen sink” rejection by applying a reference from Applicant’s same general field that listed almost all of Applicant’s claimed components. Arguing that the claimed components were old, well-known, and used by Applicant for their intended purpose, the Examiner found the claim to be obvious by metaphorically throwing everything from the reference – except the kitchen sink (hence the name for such rejections) – into the composition.

In overturning the rejection, the Board found that because the Examiner “failed to identify a reason that would have prompted a person of ordinary skill in the art to combine the claimed components as the new invention does,” and because the Examiner had not “identified a reason to select and combine these independently listed components, absent Appellant’s disclosure” the Examiner failed to satisfy the requirement set out in KSR that an Examiner must provide some “articulated reasoning with some rational underpinning to support a legal conclusion of obviousness.”

Further, and in a statement particularly helpful to applicants fighting such “kitchen sink” rejections, the Board held that “[w]ithout a reason to combine the claimed components apart from their known uses, the Examiner’s reasoning relies on ‘hindsight reconstruction to pick and choose among isolated disclosures in the prior art.’” This requirement for more than just known utility to justify the selecting and combining of multiple known components in an obviousness rejection provides applicants with many options for rebuttal, as references typically used in “kitchen sink” rejections often simply list the claimed components with little or no description of their individual properties. Because Examiners very rarely provide supplemental references describing a particular component’s properties and behavior, “kitchen sink” rejections such as the one in DeGeorge may now be easier to rebut at the PTAB in view of this decision.

Judges: D. Katz, J. New, R. Pollock

Examiners often use U.S. patents in making rejections, and they sometimes cite to the patent’s claims as evidence. In Ex parte Argembeaux the PTAB made it clear that claim scope, in and of itself, could not be used to broaden the overall teachings of a reference.

The claims in Argembeaux were directed to a skin cleansing preparation comprising less than 5% water. The Examiner cited only claim 13 of Franklin, a US patent, as the basis of the rejection – as both anticipating the pending claims and rendering them obvious. Because claim 13 of Franklin did not recite water (but listed all other components of Applicant’s claims) the Examiner found the listed components in Franklin’s claim to be anticipatory, and perhaps hedging his anticipation bet, also rejected the claims as obvious.

The Board reversed both rejections, dismissing the contention that “the absence of any mention of water in Franklin’s claims amounts to an affirmative disclosure that the compositions …. are necessarily water-free” in view of Franklin’s expressly described preference for an aqueous or aqueous-alcoholic carrier and the fact that all of the examples in Franklin used significantly more than 5% water. Based on the totality of Franklin’s disclosure, and finding no explicit disclosure affirmatively stating that water is merely an optional ingredient that may be omitted from the described compositions, the Board held that one of ordinary skill would not immediately envision (anticipation) nor be led to (obviousness) a composition as claimed containing less than 5% water.

The Argembeaux case can thus be useful in rebutting rejections where an Examiner improperly relies on a U.S. patent’s claims as evidence of prior art outside the scope of the specification’s underlying description.

Judges: R. Lebovitz, F. Prats, J. New

In Ex Parte Mitani, Japan Tobacco took a creative approach in attempting to overcome a non-statutory obviousness-type double patenting rejection before the Patent Trial and Appeal Board: they argued that an improper Markush group rejection during prosecution was tantamount to a restriction requirement, and that it afforded Appellant with “safe harbor” protection under 35 U.S.C.121.

Rather than arguing the merits of the rejection, which was based on an isomeric/close structural similarity relationship between the claimed and the patented compounds, Appellant argued that the Examiner’s improper Markush group rejection, made in the patented case, was a de facto restriction requirement that forced Appellant to prosecute only one of four possible bicyclic substituents. To make them file a terminal disclaimer in a child case in which a different bicyclic structure was being pursued was argued to be unfair.

While sympathetic, the Board found itself constrained by the strict guidance given by the Federal Circuit in Geneva Pharms., Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1382 (Fed. Cir. 2003) that “§ 121 only applies to a restriction requirement that is documented by the PTO in enough clarity and detail to show consonance.” Because Appellant did not cite to any documented restriction requirement in the application under appeal (or any application in the chain of priority) between the subject matter claimed and the patented subject matter, and because Appellant did not identify any authority allowing the Board to substitute an improper Markush group rejection for a documented restriction requirement, the Board affirmed the Examiner.

Takeaway: The safe harbor protection under 35 U.S.C. 121 is contingent on a documented restriction requirement in the application under appeal (or any application in the chain of priority) between the subject matter claimed and the patented subject matter. One issue that did not seem to be fully taken into consideration in this appeal was the issuance of an Election of Species requirement in the abandoned parent application, in which the Examiner stated that “each compound is distinct, having different chemical and physical properties, and is made in a different way. In addition, these species are not obvious variants of each other based on the current record.” Because no prior art was used in the double patenting rejection, this statement of patentable distinctness should still apply.

Judges: E. Grimes, R. Lebovitz, F. Prats

The Patent Trial and Appeal Board issued a decision in Ex Parte Shaw in which an Examiner’s choice of lead compounds (i.e., prior art compounds identified by the Examiner which are then modified to produce the claimed compounds) was reviewed.

In Shaw, Appellant’s principal argument was that the Examiner lacked any basis for choosing Examples 33 and 53 of the primary reference as lead compounds because there was nothing in the reference that distinguished them from the other 363 disclosed compounds. Arguing that the reference failed to provide specific, favorable biological activity for Examples 33 and 53, and citing the activity requirements for lead compounds set out in Daiichi Sankyo Co., Ltd. v. Matrix Labs. Ltd., 619 F.3d 1346 (Fed. Cir. 2010) (“proving a reason to select a compound as a lead compound depends on more than just structural similarity, but also knowledge in the art of the functional properties and limitations of the prior art compounds. Potent and promising activity in the prior art trumps mere structural relationships.”) Appellant urged that the Examiner’s selection of Examples 33 and 53 was improperly based on hindsight structural similarity to the claimed compounds, as there was simply no other good reason to choose Examples 33 and 53 as lead compounds.

The Board disagreed, affirmed the Examiner, and cited a passage in the primary reference seemingly generic to all compounds disclosed therein:

The compounds of Examples 1-365 were tested in the … in vitro AMPK activation assay . . . and found to have EC50 values of less than 10 micromolar and greater than 80% maximum AMP activation.

In explaining its opinion, the Board took the position that this indication of activity was sufficient to justify the Examiner’s choice of lead compounds, even in view of the Daiichi court’s instruction, cited with approval by the Board, that:

[T]he analysis still requires the challenger to demonstrate by clear and convincing evidence that one of ordinary skill in the art would have had a reason to select a proposed lead compound or compounds over other compounds in the prior art.

While the primary reference in Shaw did not do this, likely underlying the Board’s decision were several factors hinted at in the decision – the fact that the lead compound analysis was Appellant’s only real argument, and the fact that Appellant’s claimed compounds were only as efficacious as those of the primary reference.

Takeaway: In Shaw we see the Board willing to bend somewhat on the requirements of the lead compound analysis in a case where Appellant was not able to (or at least, did not) argue the existence of better lead compound candidates in the prior art, and in which no unexpected results were provided. With nothing to tip the scales in Appellant’s favor, the Board seemed willing to set a lower limit on the evidence needed to sustain a lead compound designation.

Judges: F. Prats, R. Guest, D. Katz

In February, the Federal Circuit issued a decision in Takeda Pharmaceutical Co. v. Torrent Pharmaceuticals Ltd. concerning the obviousness of a chemical compound. Perhaps the most interesting aspect of the court’s decision was the framework that they used in making their decision.

The case arose in ANDA litigation, with Takeda alleging that Torrent would infringe Takeda’s Orange Book-listed patent claiming certain alogliptin benzoates. Torrent defended by alleging obviousness – both statutory obviousness (35 U.S.C. 103) and non-statutory obviousness-type double patenting – and in all cases relied on the obvious modification of a “lead compound” to produce Takeda’s claimed compounds.

In Takeda, central to the court’s ultimate decision-making process was determining whether there was a “reasonable expectation of success” in making Torrent’s suggested modifications. But in essentially answering this question before it was asked, the court prefaced its discussion with the following statement:

Relevant to ‘the assessment of [reasonable] expectation of success’ in all three of [Torrent’s] invalidity theories … is the undisputed factual finding that ‘in the relevant art of pharmaceutical development, very small changes in molecular structure can have dramatic effects on the properties of the molecule,’ …. Indeed, ‘the more distantly related two chemical structures are, the less probable it will be that they have the same biological effect.’ … Against this backdrop, we turn to the details of Appellants’ invalidity theories.

As one might guess just from reading this opening decisional framework, the court found in favor of Takeda, holding that a skilled artisan would not have been motivated to modify Torrent’s lead compound with a reasonable expectation of success.

Takeaway: Does the Takeda case provide us with a roadmap to nonobviousness? Perhaps. In Takeda patentee used expert testimony, buttressed by a publication, to establish the unpredictability of chemical structural changes vis-à-vis functionality in the relevant pharmaceutical art. In the absence of evidence to the contrary, the Federal Circuit found it very easy to affirm the validity of Takeda’s claims and deny Torrent’s allegations of obviousness. Using this strategy during prosecution should yield the same results, with the advantage of an “adversary” (i.e., the Examiner) who lacks the resources of a pharmaceutical litigant.

Judges: Dyk, Mayer, Chen

Newer Posts

Older Posts

Posts by Richard Treanor

Method Claims: The Importance of Claiming the Result

Appeal Briefs: The Importance of Issue Advocacy

PTAB Accepts Attorney Argument as Persuasive on Inherency

Motivation to Combine References not Enough to Show Obviousness

Federal Circuit Clarifies Willful Infringement Standard

COMBINING KNOWN INGREDIENTS – A “Kitchen Sink” Rejection Reversed by the PTAB

PATENT CLAIMS AS PRIOR ART– No Broadening Beyond Specification Disclosure

ODP Safe Harbor Provision, Close but No Cigar…

And Speaking of Lead Compounds . . .

A Roadmap for Nonobviousness?

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

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