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October 22, 2021by Richard Treanor

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


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September 17, 2021by Richard Treanor

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


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August 19, 2021by Richard Treanor1

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


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June 7, 2021by Richard Treanor

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


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May 12, 2021by Richard Treanor

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


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April 6, 2021by Richard Treanor

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


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March 5, 2021by Richard Treanor

In January of this year we reported on the Federal Circuit decision Donner Technology, LLC v. Pro Stage Gear, LLC, (link here) where the court clarified the “reasonably pertinent” test used to define the scope of analogous prior art (i.e., whether a reference outside the field of the inventor’s endeavor is “reasonably pertinent” to the particular problem with which the inventor is involved). In Donner the Federal Circuit explained that the problem to which the allegedly non-analogous reference relates must be identified and reviewed from the perspective of one of ordinary skill in the art who is considering turning to art outside their field of endeavor, and the question that must be answered is whether this person “would reasonably have consulted” the reference in solving the relevant problem.

On March 2, 2021, the Patent Trial and Appeal Board (“Board”) issued a decision in Ex parte Brophy (Appeal No. 2021-001800) reversing the Examiner’s rejection of claims to a salt substitute that relied on a reference requiring the use of an ingredient not safe for food. While two of the cited references used in the Examiner’s rejection were related to consumable salt compositions which included all the components recited in the claims, both references failed to describe the physical forms of the claimed salt substitute (solution and crystalline). In view of this omission, the Examiner cited a third reference describing an evaporative salt crystallization technique described as providing free-flowing salt crystals suitable for use in membrane electrolysis cells and in chlorine production using water, the salt to be crystallized, and a water-soluble acrylic polymer.

Appellants argued that the third reference was non-analogous with regard to its field of endeavor (salts for membrane electrolysis cells and for use in chlorine production), both in general and as evidenced by its use of acrylic acid, and provided the Examiner with a reference showing that a commercial polymer taught by the third reference was hazardous to humans. The Board agreed with Appellants and reversed the Examiner, and following the Federal Circuit’s guidance in Donner held that the Examiner failed to “address the underlying question why one of ordinary skill in the art would have looked to [the third reference’s] method for producing electrolysis salts to produce salt seasoning compositions intended for food.”

Takeaway: Non-analogous art arguments, while historically difficult, seem to be gaining more traction recently. Both the Federal Circuit’s and the Board’s recent guidance should be used during prosecution to establish all the elements of the argument, should appeal become necessary.

Judges: B. Franklin, J. Housel, and J. Snay


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January 29, 2021by Richard Treanor

The Federal Circuit’s recent decision in SIMO Holdings, Inc. v. Hong Kong uCloudlink Network Technology Limited (decision) highlights the importance of English grammar when drafting, revising, and amending patent claims in the U.S.

In SIMO, the relevant claim language reads:

A wireless communication client or extension unit comprising a plurality of memory, processors, programs, communication circuitry, authentication data stored on a subscribed identify module (SIM) card and/or in memory and non-local calls database, …

which, for purposes of discussion, can be rewritten as:

A … comprising a plurality of A, B, C, D, E and F, …

The District Court construed the important phrase “a plurality of” to require only “at least two” members selected from the entire list of A-F (e.g., A and B, A and F, C, D, and E, etc.), and as a result found the claim to be infringed. The Federal Circuit disagreed with this claim interpretation, however, and interpreted the claim to require at least two of each of the listed items.

The Federal Circuit based its decision on a very well-known English grammar sourcebook (William Strunk, Jr. & E.B. White, The Elements of Style) and on its earlier SuperGuide decision where it found that, as a matter of ordinary and customary meaning, a phrase grammatically comparable to “a plurality of” at the start of a list of items, joined together by “and”, applied to each item in the list, not to the list considered as a whole. The court further noted that the mix of plural, singular, and mixed-use forms of words in the list following “a plurality of” (“memory,” “processors,” “programs,” “circuitry,” “data,” “database”) made the SIMO phrase “a bit of a mess grammatically” and explained that, because the list uses “and” rather than “or,” the phrase is properly understood as if the word “of” appears before each item (i.e., a plurality of A, of B, of C, of D, of E and of F). As a result, and given the proper interpretation of the claim, the court determined that there was no infringement.

Takeaway: The SIMO case provides a good reminder to review U.S. claims for both accuracy and English grammar, either prior to submission (e.g., in a preliminary amendment) or in response to an Official Action.

Judges: O’Malley, Wallach, Taranto


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January 26, 2021by Richard Treanor

Typically, the first step in mounting an obviousness challenge is to determine the scope and content of the prior art. However, more than just an early publication date is required for a reference to qualify as prior art against a given claim – it must also be “analogous.”

Traditionally, two separate tests are used to define the scope of analogous prior art: (1) whether the art is from the same field of endeavor as the claimed invention, regardless of the problem addressed and, (2) if the reference is not from within the field of the inventor’s endeavor, whether the reference is reasonably pertinent to the particular problem with which the inventor is involved. Recently, in Donner Technology, LLC v. Pro Stage Gear, LLC, (decision) the Federal Circuit clarified test (2) – the “reasonably pertinent” test.

In Donner the issue was whether Mullen, directed to supported electrical relays, was analogous to the target patent, directed to a guitar effects pedalboard. While the PTAB held that Mullen was not analogous, the Federal Circuit disagreed.

In explaining its decision, the Federal Circuit clarified that the dividing line between reasonable pertinence and less-than-reasonable pertinence ultimately rests on the extent to which the reference of interest and the claimed invention relate to a similar problem or purpose. Thus, when addressing whether a reference is analogous art with respect to a claimed invention under a reasonable-pertinence theory, the problems to which both relate must be identified and compared. This identification and comparison, the court noted, must be from the perspective of one of ordinary skill in the art who is considering turning to art outside their field of endeavor, and the question that must be answered is whether this person “would reasonably have consulted” the reference in solving the relevant problem even if they did not understand each and every last detail of the reference.

In applying this framework to the PTAB’s decision the Federal Circuit found several points lacking, and vacated their decision while providing a helpful “roadmap” to follow when addressing the issue of analogous art.

Judges: Prost, Dyk, Hughes


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January 21, 2021by Richard Treanor

We are all aware of the challenges that prosecuting a claim including the term “about” can raise during prosecution – whether it is definite, whether it is defined explicitly or in some other form in the specification, etc. – but the recent Federal Circuit case Par Pharmaceutical, Inc. v. Hospira, Inc. (Fed. Cir. 2020) (decision) demonstrates the possible usefulness of the claim term “about”, and perhaps justifies the extra effort that can be necessary to bring such a claim to allowance.

In Par Pharmaceutical, the Federal Circuit found that Hospira’s generic allergy drug containing 9 mg/ml of a tonicity regulating agent literally infringed Par patents requiring “about 6 to 8 mg/mL of a tonicity regulating agent”, thereby avoiding all the issues that surround (and generally reduce or defeat) an allegation of infringement under the Doctrine of Equivalents.

Relying on the fact that Hospira had agreed that “about” meant, simply, “approximately” and on the District Court’s pretrial order that “[t]he extent of the term ‘about’ must be determined using a functional approach” the Federal Circuit found that the claim term ‘about’ avoided a strict numerical boundary of the specified parameter and was instead confined to what a person having ordinary skill in the art would reasonably consider ‘about’ to encompass. And because neither party proposed a claim construction based on intrinsic evidence (i.e., amendments and arguments made during prosecution, specification definitions, etc.), the Court explained that the scope of the term “about” must be tied to the purpose of the limitation in the claimed invention—not the purpose of the invention itself.

Then, in agreeing with Par’s expert, who explained that the limitation’s endpoints were not critical and that, given the purpose of the limitation, a relevant artisan would reasonably understand 9 mg/ml to fall within “about 6 to 8 mg/mL”, the Federal circuit affirmed the District Court’s finding of literal infringement, finding that such an expansion of the limitation was only a “modest amount”.

Takeaway: As mentioned above, this finding of literal infringement through the use of the claim term ‘about’ avoided consideration of all of the events that typically occur during prosecution and which generally narrow any possible application of the Doctrine of Equivalents, and delivered a significant victory to patentee. In view of this, consideration should be given to including the term ‘about’ in one or a few claims of a given claim set.

Judges: Dyk, Taranto, Stoll