Richard Treanor, Author at ElementIP Law

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

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

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

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

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

On November 9, 2020, the Patent Trial and Appeal Board issued a decision in Ex parte Tramontano et al. (Appeal 2020-002413) in which a misplaced claim interpretation/35 U.S.C. 112 argument distracted the Board from finding clear error in the Examiner’s obviousness rejection.

In Tramontano Claim 25, relating to the formation of a gel at a tissue treatment site, was the representative claim:

25. A process for forming a gel comprising:

forming an oxidized cellulose solution;

forming a precipitating composition; and

contacting the oxidized cellulose solution and the precipitating composition at a tissue treatment site thereby precipitating oxidized cellulose from the oxidized cellulose solution and forming the gel.

As explained in the Tramontano specification, the claimed gel may be used as an adhesive to seal tissue and/or to provide for the delivery of bioactive agents ([0274]).

During prosecution, the Examiner concluded that it would have been obvious to a person of ordinary skill in the art to substitute the cellulose ether used as the polymer in the cross-linked gels taught by Gehrke, with oxidized cellulose as taught by Blaskovich, at a tissue treatment site, as taught by Hubbard. In their Appeal Brief Appellants argued, among other things, that none of the cited references disclosed their claimed “precipitating composition” and, in response to a statement made by the Examiner in the Advisory Action (“it is not clear what the precipitation composition ….comprises”) argued to the Board that the lack of a 35 U.S.C. 112 rejection meant that the claim term “precipitation composition” was definite. Appellants further provided the Board with a legal framework for determining the meaning of a claim term, and argued that the references did not disclose the use of a “precipitating composition” as properly understood under their framework.

In affirming the rejection the Board first felt “obliged to make several initial points,” constituting over four full pages of their nine page analysis, the first of which was to correct Appellants’ legal framework for determining the meaning of a claim term, and the second of which was to apply the correct standard and find that the Blaskovich reference did indeed disclose the use of a “precipitating composition.” In coming to this conclusion and affirming the rejection, the Board characterized Appellants’ arguments regarding definiteness as “largely irrelevant” in view of the acknowledged fact that no 35 U.S.C. 112, second paragraph, rejection was at issue.

In Tramontano, the Board was clearly distracted (and perhaps irritated) by Appellants’ unnecessary arguments regarding definiteness to the point that Appellants’ other, stronger, arguments were ignored. In this regard, one of the applied references, Hubbard, was cited as teaching the delivery of oxidized cellulose, in gel form, to a tissue site. However, while Appellants argued that the combined references failed to suggest contacting an oxidized cellulose solution and a precipitating composition at a tissue treatment site, thereby forming the gel at the treatment site as claimed, this argument was not specifically addressed by the Board. Instead, the Board emphasized the presence of a “precipitating composition” and “oxidized cellulose solution” in the Gehrke and Blaskovich references.

Takeaways: The Tramontano case illustrates the importance of leading with the best arguments and focusing the Appeal Brief on issues of clear error in the rejections of record. In addition, the Tramontano case provides us with a reminder to review claims for the presence of unnecessary steps, such as the “forming” steps in Claim 25 above. Such unnecessary steps can provide infringers with the possible defense of “divided infringement” if third parties perform certain steps within a claimed method.

25. (Amended) A process for forming a gel comprising:

forming an oxidized cellulose solution;

forming a precipitating composition; and

contacting the an oxidized cellulose solution and the a precipitating composition at a tissue treatment site thereby precipitating oxidized cellulose from the oxidized cellulose solution and forming the gel.

Judges: Prats, Katz, New

On September 15, 2020, the Patent Trial and Appeal Board (PTAB) issued a decision in Ex parte Lebovich reversing the Examiner’s rejection of claims directed to a packaged food assembly that allows the consumer to see the package contents from all angles while still permitting substantial labeling of the package. While the Board found that the Examiner’s rejection did present a prima facie case of obviousness, it further determined that Appellant’s objective evidence of nonobviousness was sufficient to rebut the Examiner’s prima facie case.

Perhaps the most interesting aspects of the Lebovich case are Appellant’s successful presentation of several types of secondary considerations not often encountered in typical prosecution (i.e., commercial success, industry praise and recognition, and solving a long-felt, unmet need), and their successful assertion that the development of brand loyalty beyond what is typical for a staple food, and particularly for meat, attributable to their food assembly qualified as an “unexpected result.”

Takeaway: This “out of the box” thinking in Lebovich serves to remind us of the essentially limitless contours of the unexpected results analysis, and should encourage us to consider all aspects of a claimed invention – how it is used, stored, transported, etc. – during prosecution in order to increase our level of advocacy.

Judges: J. Smith, G. Best, J. Snay

On July 14, 2020, the Patent Trial and Appeal Board issued a decision in Ex parte Park (Appeal 2019-006050) in which a rejection over an overlapping prior art genus was determined to be insufficient to establish a prima facie case of obviousness under both a lead compound analysis and an obvious equivalents/overlapping genus analysis. In addition, the Examiner’s initial rejection of subject matter beyond the elected specie was determined to be a withdrawal of the election requirement.

On August 7, 2020, the Patent Trial and Appeal Board issued a decision in Ex parte Koseoglu (Appeal 2019-002720) and reversed an obviousness rejection of a catalyst composition. Implicit in the Board’s decision was the determination that one of the catalyst components, having only an upper limit on its amount, was present in the catalyst composition.

On July 16, 2020, the Federal Circuit issued a decision in Akeva L.L.C. v. Nike, Inc., Addidas America, Inc. (nonprecedential) in which the difference between removing a subject matter disclaimer from the specification, as opposed to removing one made in amendments and/or remarks during prosecution, amounted to the difference between winning and losing.

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Posts by Richard Treanor

A Roadmap for Nonobviousness?

Non-analogous Art Arguments Gaining Traction

Your Mother Was Right – Grammar Matters

Yes, But Is It Analogous?

“About 8” Encompasses 9 – Literally

Misplaced Argument Distracts Board from Finding Clear Error in Examiner’s Obviousness Rejection

Achieving “Brand Loyalty” Found to Be a Surprising Result

Board Finds Rejection Based on Overlapping Prior Art Genus Insufficient; Election Requirement Withdrawn by Broadened Initial Search

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