August 26, 2022by Beau Burton

Ex parte Bhatnagar is a recent decision in which the Patent Trial and Appeal Board (PTAB) reversed an obviousness rejection because the Examiner’s reason for modifying the prior art was not commensurate with the underlying disclosure.

The claims in Bhatnagar were directed to a system that included a maintenance pet food having a density from 400 g/l to 600 g/l and a reduced caloric pet food having a density from 300 g/l to 450 g/l.

The primary reference, Pan, disclosed a system with a maintenance pet food and a reduced caloric pet food, but did not mention densities. To remedy this deficiency, the Examiner relied on a secondary reference, Mao, and argued it would have been obvious to have a “density in the range of 200–600 g/l because the pet food has significantly improved palatability.” The PTAB disagreed.

The Board rejected the Examiner’s position because the improved palatability described by Mao was expressly tied to another feature. Specifically, Mao taught:

It is well-known in the art to incorporate palatability enhancing ingredients in dry pet food [products] to increase the palatability thereof and to make them more appealing to pets…. palatability of certain dry pet food products can be improved significantly by coating the food product with a covering layer that contains dry yeast extract, edible phosphate salt[,] and optionally other edible components.

According to the PTAB, the Examiner improperly associated the improvement in palatability, which was expressly tied to the presence of a covering layer, with the density.

Thus, while Mao broadly disclosed a pet food having a bulk density of 200–600 g/l (overlapping with each of the claimed ranges), the PTAB found the Examiner failed explain why, given the teachings of Mao, one of ordinary skill in the art would have been prompted to make the proposed modification to Pan’s food composition density. With no other reason for the modification evident from the record, the PTAB reversed the obviousness rejection.

Takeaway: Ex parte Bhatnagar embodies the recognition from KSR that “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” Beyond that, Bhatnagar shows that an Examiner cannot arbitrarily associate benefits and features in the prior art to arrive at a motivation to modify. Here, the density of the pet food had nothing to do with the benefit cited by the Examiner. This is why it is important to verify and, when appropriate, challenge the accuracy of an Examiner’s characterization of the prior art.

Judges: J. Bahr, P. Kauffman, S. O’Hanlon


July 21, 2022by Beau Burton

A specification must enable one of ordinary skill in the art to practice the full scope of the claimed invention. But as noted by the Federal Circuit, “[t]hat is not to say that the specification itself must necessarily describe how to make and use every possible variant of the claimed invention, for the artisan’s knowledge of the prior art and routine experimentation can often fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending upon the predictability of the art.”

A recent decision from the Patent Trial and Appeal Board, Ex parte Seppo, shows the interplay between enablement and a skilled artisan’s ability to extrapolate beyond potentially inoperative embodiments.

In Seppo, the claims covered a method of generating a composite image of a region of a human tissue sample by generating a first image by binding a human target protein-specific monoclonal antibody labeled with a fluorophore and detecting the bound fluorophore; generating a second image by hybridizing a nucleic acid probe labeled with a fluorophore and detecting the hybridized probe fluorophore; and generating a composite image by registering fluorescent signals from the first image with fluorescent signals from the second image.

The Examiner took issue with a theoretical embodiment involving the use of the same fluorescent label/marker/signal for both steps, stating:

If the label used for the monoclonal antibodies and the label used on the nucleic acid probes is the same … one would not be able to accurately and reproducibly >>register<<, in a composite image, the fluorescent signals from each of the different binding reactions, as they would all be the same.

The Examiner further noted that the examples in the specification used multiple labels on different antibodies and nucleic acid probes, but failed to show how to obtain a composite image with the same fluorescent label – an embodiment covered by the independent claim. Accordingly, the Examiner found “the specification, while being enabling for the method of claim 1 wherein different fluorophores are used … does not reasonably provide enablement for use of the same fluorescent label/marker/signal for all steps.” The Board disagreed.

First, the Board found that although the Examiner “has posited one variant of the claimed method … that in his view would not yield useful information … the Examiner’s reasoning itself suggests that a skilled artisan would expect that embodiment to be of limited or perhaps no utility, and thus those in the art would have known to avoid it.”

Second, the Board noted that the Examiner’s reasoning at best identified a single inoperative embodiment encompassed by the claim, while Federal Circuit precedent suggest that number must be significant and force one of skill in the art to experiment unduly in order to practice the claimed invention. Absent a persuasive showing that undue experimentation would be required to practice the claimed method, the Board reversed the rejection.

Takeaway: When an Examiner alleges that a claim does not satisfy the enablement requirement because it encompasses one or more inoperative embodiments, the Examiner must show that the inclusion of inoperative embodiments is so significant that a skilled artisan would be forced to experiment unduly. In Seppo, the Examiner’s rationale folded on itself because the Examiner admitted that a skilled artisan would have expected his single, hypothetical inoperative embodiment to provide limited information such that a skilled artisan would know to avoid it.

Judges: D. Adams, E. Grimes, J. Fredman


May 26, 2022by Beau Burton

Conclusions of obviousness require a reasonable expectation of successfully making and using an applicant’s claimed invention. Ex parte Micka (Appeal 2021-003755) is a recent decision from the Patent Trial and Appeal Board (“Board”) that shows whether there is a reasonable expectation of success can depend on the number of selections required to arrive at a claimed invention and how those selections would have been expected to affect the resulting combination of elements/ingredients.

The claims in Micka were directed to a process of preparing a solid dosage form by blending an active pharmaceutical ingredient (API) with a natural gum and a particular combination of  hydrophilic gelling polymers, “wherein the solid dosage form deters abuse and provides immediate release of the at least one API.”

The Examiner relied on a prior art reference for the specific ingredients and alleged that it would have been obvious to combine them in the manner claimed because the reference describes blending the ingredients and the dosage form as providing immediate release and being abuse resistant. This, however, was not the complete picture.

First, the appellant pointed out that the prior art described hundreds of polymers, diluents, binders, lubricants, disintegrants, gelling agents, plasticizers, and release modifiers at any concentration from 0-95% w/w in the abuse deterrent compositions. According to the appellant’s estimate, which the Examiner did not contest, the prior art disclosed ~17 trillion possible combinations of polymers, diluents, binders, lubricants, disintegrants, gelling agents, plasticizers, and release modifiers before even considering the concentrations.

Second, the appellant pointed out that the prior art’s focus was on controlled release compositions. The appellant’s argument here was not as strong because the prior art reference did use the phrase “immediate release,” but only once in the abstract. The Examiner grabbed onto this single mention of “immediate release” to argue there would have been a motivation and a reasonable expectation of success. The Board did not agree.

The Examiner’s error here resided in the fact that the prior art reference did not differentiate between excipients that would result in controlled release and immediate release. In the Examiner’s view, this was irrelevant because the same ingredients were suitable for making both. Not only did the Board disagree with this finding, but the Board also found that the prior art taught the choice of ingredients affects the release such that “it cannot be the case that any and all of these possible combinations will provide immediate release dosage forms.” Having no guide for what ingredient(s) could provide an immediate release composition, the Board found there was no reasonable expectation of success and reversed the rejection.

Takeaway: The factual scenarios under which the lack of a reasonable expectation of success can be successfully argued are less common than motivation to combine. A key in Micka was the claimed composition providing the immediate release of the API. And the facts in Micka were particularly strong because of the litany of selections required to arrive at the claimed composition and the complete lack of guidance as to which selections would have resulted in the immediate release property. Without claiming the immediate release property, the obviousness determination would have devolved into whether it would have been obvious to select the combination of ingredients – a more difficult position to rebut.

Judges: J. Morgan, J. Schneider, M. Valek


April 21, 2022by Beau Burton

Nine times out of ten a negative limitation satisfies the written description requirement when the specification positively describes the limitation to be excluded or better yet provides a reason to exclude the limitation. The rationale for the former being that a description of the whole, necessarily describes the part remaining. For instance, when the specification discloses a composition that includes an additive selected from A, B, and C, there is support for a composition that does not include A, B, or C.

Satisfying the written description requirement without a positive recitation of the limitation to be excluded is rare; however, Ex parte Kroepke provides an example in which the Patent Trial and Appeal Board found support for a negative limitation based on silence.

The following claim on appeal is illustrative:

A cosmetic or dermatological preparation, wherein the preparation comprises from 0.01 % to 5 % by weight of at least one red light-filtering dye, at least one white pigment, and from 0.0001 % to 10 % by weight of at least one anti-inflammatory active ingredient which comprises at least one aqueous extract of Glycyrrhiza inflata, and wherein the preparation does not contain strontium cations.

Of note here is that the specification did not positively mention strontium cations, group II cations, or even alkaline earth metals. The closest disclosure of cations appears to be from ingredients in the examples such as magnesium sulphate, sodium citrate, and potassium sorbate. However, Appellant did not rely on these cation containing ingredients. Appellant simply argued that the written description requirement was satisfied because the specification included “sixty exemplified (most diverse) preparations, none of which contains strontium cations.”

The Examiner disagreed, finding Appellant’s disclosure “as a whole does not conceptualize that the preparation should or should not contain strontium cation. Further, as to the sixty examples disclosed in the application, no explicit[] disclosure of strontium cation does not mean that exemplified preparations do not contain strontium cation.”

The Board found Appellant’s position more persuasive in view of the Federal Circuit’s recent Almirall, LLC v. Amneal Pharms. LLC decision, which held:

[A] reference need not state a feature’s absence in order to disclose a negative limitation. Instead, it was reasonable for the Board to find that, in the context of Garrett, a skilled artisan would recognize that the reference discloses a complete formulation—excluding the possibility of an additional active ingredient… It is undisputed that Garrett discloses dapsone formulations that lack adapalene. The Board thus did not err in concluding that Garrett discloses the negative adapalene claim limitation.

28 F.4th 265, 273–274 (Fed. Cir. 2022) (citations omitted).

At first glance, Kroepke appears to extend the rationale from Almirall permitting the exclusion of an additional unrecited active ingredient to the exclusion of any unrecited ingredients. However, upon closer inspection, Kroepke fits the same pattern as Almirall. First, the invention in Kroepke related to “preparations that include a combination of a dye and an anti-inflammatory active ingredient, and particularly to preparations for the prophylaxis and treatment of sun-irritated skin that aid the body’s own repair mechanisms.” Second, the prior art relied upon by the Examiner in Kroepke for an obviousness rejection (which was also reversed by the Board), required the mandatory presence of strontium for its anti-irritation function when used in combinations with ingredients such as moisturizers and anti-inflammatory agents. Consequently, both Kroepke and Almirall support the exclusion of an additional active ingredient where there are exemplary and complete formulations that do not include an additional active ingredient.

Takeaway: Kroepke and Almirall illustrate a continued expansion of negative limitations satisfying the written description requirement to an extent that might not be possible in other jurisdictions. Nevertheless, it is important to keep in mind that Kroepke and Almirall fit a specific pattern in which exemplary compositions include an active ingredient, and the negative limitation relates to another active ingredient. It is unlikely that these holdings can be extended to the exclusion of any ingredient that is not recited in an example.

Notably, Appellant never had the chance to raise or argue the facts of the Almirall decision because it was decided only one month prior to the decision in Kroepke. Thus, the Board’s reliance on Almirall shows it is applying the most recent Federal Circuit precedents.

Judges: D.E. Adams, J. N. Fredman, T. Chang


March 24, 2022by Beau Burton
Obviousness rejections of composition claims are often premised on an examiner’s assertion that it would have been obvious to replace a component in a primary reference composition with a functionally equivalent component from a secondary reference. As discussed in a prior blog, the context of a disclosure of functional equivalence is key because obviousness requires an examiner to show a skilled artisan would have had an apparent reason to modify the prior art to arrive at the claimed invention. And when a component is taught to be an alternative for a completely different purpose, this undercuts the apparent reason to modify the prior art. Ex parte Shooshtari is illustrative.

The claims on appeal in Shooshtari were drawn to a binder composition that included “a catalyst for catalyzing a crosslinking reaction between the reducing sugar and the crosslinking agent, wherein the catalyst comprises a sulfonic acid compound.” The primary reference relied on by the Examiner disclosed a binder composition that included a pH adjuster, such as HCl, for preventing unwanted polymerization, but it did not disclose the presence of a sulfonic acid compound.

To remedy this deficiency the Examiner relied on a secondary reference that taught a binder composition containing a mineral acid catalyst, such as HCl or p-toluene sulfonic acid, to effect crosslinking reactions. According to the Examiner, it would have been obvious to replace the HCl pH adjuster of the primary reference with the sulfonic acid polymerization catalyst of the secondary reference. The Board disagreed.

In particular, the Board found that the primary reference taught HCl for the sole purpose of adjusting the pH to inhibit unwanted polymerization, while the secondary reference taught HCl and sulfonic acid as acid catalysts to effect crosslinking reactions–a completely different purpose. Consequently, the Board held the Examiner failed to identify a reason why a skilled artisan would have sought to include the acid catalyst of the secondary reference in the composition of the primary reference.

Takeaway: Shooshtari shows the value in analyzing the purpose of each component of a composition when facing an obviousness rejection that relies on functional equivalence. The purpose and function of the components ties into whether there is an apparent reason to modify the prior art in the manner proposed by the Examiner. Here, the purpose of the components in each of the references was contradictory to the other such that a skilled artisan would not have had a reason to equate and replace them. Accordingly, when facing a rejection that relies on functional equivalence it is important to fully assess the purpose and function of the components involved.

Judges: T. Ownes, W. Wilson, J. Snay


March 17, 2022by Beau Burton

There is no requirement to provide unexpected results until the Patent Office establishes a prima facie case of obviousness. Seems simple, but Ex parte Popplewell shows Examiners still put the cart before the horse and improperly seek evidence of unexpected results.

This initial burden for showing unpatentability falls on the patent office because § 102 mandates that “[a] person shall be entitled to a patent unless.” See In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002) (the PTO “bears the initial burden of presenting a prima facie case of unpatentability… However, when a prima facie case is made, the burden shifts to the applicant to come forward with evidence and/or argument supporting patentability.”). Despite this unambiguous framework of burden shifting, Examiners routinely seek evidence of unexpected results prematurely.

In Popplewell, the independent claim required a spray dryer in a particular method to have inlet and outlet air humidity values between 0–4 and 10–20 g H2O/kg dry air, respectively. The Examiner admitted that the prior art relied on did not teach the inlet or outlet air humidity. While this should have been the end of examination, the Examiner took the position that the claimed inlet and outlet air humidities did not provide an unexpected result over the prior art.

On appeal, the Board found the Examiner’s statement regarding the claimed air humidities to be nothing more than a “mere conclusory statement[]” lacking an “articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.” From the Board’s perspective, the Examiner failed to show that the prior art taught or suggested the inlet and outlet air humidities and failed to provide any explanation as to why the claimed humidities would have been obvious. Consequently, the Board held the Examiner’s request for a showing of unexpected results was inappropriate.

Takeaway: Poppelwell is a good reminder that: one, “obviousness requires a suggestion of all limitations in a claim”; and two, an Examiner’s demand for evidence of unexpected results prior to showing a suggestion of all limitations is improper. CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003). It is surprising to see a case like this on appeal because it requires the Examiner and an appeal brief review panel to misunderstand the burden shifting framework before the case is sent to the Board, but it shows why some appeals are inevitable.

Judges: G. Best, L. Ren, M. Cashion


February 3, 2022by Beau Burton

In Ex parte Kano (Appeal No. 2021-004640), the Patent Trial and Appeal Board (“Board”) rejected an Examiner’s finding of obviousness that was premised on a nonoverlapping range being “sufficiently close.”

The independent claim on appeal was directed to a non-oriented steel having a chemical composition defined by various ranges of elements (e.g., C, Si, Mn, Al, P, S, N, etc.) and exhibiting, among other things, an X-ray diffraction (XRD) intensity ratio, I{100}/I{111}, between 0.50 and 1.18.

The primary reference relied on by the Examiner disclosed a non-oriented electrical steel sheet having a chemical composition that included each of the chemical elements in overlapping amounts, but failed to describe the intensity ratio. To remedy this deficiency, the Examiner relied on a secondary reference; however, its intensity ratio was greater than or equal to 1.20.

Notwithstanding the absence of an overlapping intensity ratio, the Examiner maintained obviousness on the basis that a steel sheet constructed from the prior art with an intensity ratio of 1.20 was sufficiently close to the claimed 1.18 ratio that one of ordinary skill in the art would expect them to have the same properties. The Board did not agree.

In particular, the applicant’s specification showed that the claimed intensity ratio resulted from a combination of the claimed composition and holding the composition at 550–700°C for 10–300 seconds (an intermediate holding step). The primary and secondary references relied on by the Examiner performed annealing processes at 950°C and 860°C, respectively, but did not include an intermediate holding step. Thus, the Board held that a skilled artisan would not have expected the steel composition from the Examiner’s hypothetical construct to have an intensity ratio within the claimed range and reversed the Examiner’s rejection.

Takeaway: While a prima facie case of obviousness may be established where the claimed range and the prior art range do not overlap, it is essential that there be an expectation that the properties would be the same. This expectation may be rebutted by information in the applicant’s own specification as in Kano or with additional experimental evidence. Another great source of rebuttal evidence is the prior art itself because a lot of times the prior art will associate its nonoverlapping range with a particular property and describe values outside that range (likely values within the claimed range) as inferior or different in some way such that a skilled artisan would not expect the properties to be the same.

Judges: J. Housel, W. Wilson, J. Gupta


January 7, 2022by Beau Burton

In Ex parte Zhang (Appeal No. 2021-005022), the Patent Trial and Appeal Board (“Board”) rejected an Examiner’s finding of obviousness that was premised on an unappreciated ratio being a result-effective variable.

The independent claim on appeal read:

1. A sinterable conductive composition comprising:

a metal component having an average particle diameter of greater than about 150 nm to about 100 μm…;

a sintering agent; and

an emulsion comprising water, and

at least one particulate polymer having an average particle diameter

wherein a ratio of average metal component particle diameter to average particulate polymer particle diameter is between 1:1 and 10:1.

The Examiner rejected claim 1 over a primary reference that disclosed a metal component having an overlapping average particle diameter and a secondary reference disclosing metal particles, a sintering promoter, and an emulsion containing resin fine particles. Equating “fine particles” with nano-sized particles, the Examiner found the claimed ratio obvious (i.e., using the overlapping metal component diameter from the primary reference and the nano-sized particulate polymer diameter from the secondary reference).

In the alternative, the Examiner argued it would have been obvious to optimize the “fine particle” size to sufficiently disperse the polymer particles in the emulsion.

The Board rejected both of the Examiner’s positions. The Board first emphasized that claim 1 required a specific ratio particle size of the metal component and the polymer particle, and “not merely a size range for the polymer particle.” The primary reference did not disclose a particulate polymer so it could not possibly recognize a relationship between the metal component and the polymer particle.

As for the secondary reference, the diameter of the polymer relied on by the Examiner was for a precursor – not the final product – and nowhere did it suggest a relationship between the polymer particle size and metal particle size.

In the Board’s own words:

Missing from the record is any evidence of an interdependent relationship between the diameter sizes of the metal component and the polymer particle. In addition, nothing in the combined references suggests or recognizes that the claimed ratio relationship is a result effective variable.

We cannot accept general conclusions about what is ‘basic knowledge’ or ‘common sense’ as a replacement for documentary evidence for core factual findings in a determination of patentability.

Takeaway: Sometimes patentability resides in a relationship between properties that are seemingly obvious when considered individually. As shown in In re Zhang, when a reference relied on by the Examiner is missing the claimed property, it cannot possibly recognize a relationship involving that property. And even where a reference has the individual properties needed to arrive at the claimed relationship, the relationship will not obvious unless there is an overlap or a recognition of an interdependent relationship between the properties involved in the relationship.

Judges: C. Timm, D. Dennett, M. Cashion, Jr.


November 29, 2021by Beau Burton

In Ex parte Talamoni (Appeal No. 2020-006553), the Patent Trial and Appeal Board (“Board”) rejected an Examiner’s claim construction overriding the phrase “derived from the reaction product of” with “comprising.”

The independent claim on appeal read:

A composition comprising an acrylic adhesive derived from the reaction product of

(a) an acrylic ester of monohydric alcohol having an alkyl group of the 5 to 10 carbon atoms; and

(b) a nonpolar acrylic monomer having a solubility of less than 9.2 as measured by the Fedors method using a homopolymer of the nonpolar acrylic monomer,

wherein the reaction product has a side chain crystallinity.

The Examiner rejected the claim as anticipated by or, in the alternative, obvious in view of a reference that disclosed a terpolymer produced from monomers (a) and (b) and 0.5–5 wt% of a monomer (c) (a monoolefinically unsaturated ketone). The Examiner argued the “side chain crystallinity” although not disclosed would be present in view of In re Spada (i.e., “[w]hen the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not”). The Board disagreed.

At the outset, the Board found that the phrase “derived from the reaction product of” monomers (a) and (b) would be understood by those of skill in the art to exclude the terpolymer of the prior art derived from monomers (a), (b), and (c). The Board did agree that the use of “comprising” in the preamble opened the claim up to additional unrecited ingredients such as tackifiers but it did not override or expand the requirement for a reaction product obtained from the two monomers (a) and (b). Accordingly, the Board reversed the anticipation rejection.

As for obviousness, the Board found that the prior art taught away from omitting monomer (c) since it taught the monomer (c) provided the terpolymer with stability and stated, “if the amount of monomer (c) is less than 0.5 mass %, an insufficient effect is produced by the addition.” With no reason for why a person of ordinary skill in the art would have been motivated to omit monomer (c) from the prior art, the Board reversed the obviousness rejection.

Finally, the Board emphasized that the Examiner was not entitled to rely on the presumption from Spada because Appellant’s claim did not cover a reaction mixture containing monomer (c) and the breadth of monomer (c) in terms of the amount and potential species was too broad to conclude that the prior art’s terpolymer was substantially identical to the claimed copolymer of monomers (a) and (b).

Takeaway: In re Talamoni is notable for two reasons. First, the Board found the phrase “derived from the reaction product of … (a) … and (b)” to be closed. While savvy US applicants are accustomed to “comprising” and “consisting of,” phrases like this tend to be more common in applications originating outside the US. Accordingly, it is a good practice to replace uncommon transitional phrases with the corresponding US equivalent (e.g., comprising, consisting essentially of, or consisting of) to limit these types of disputes. And second, the Board correctly found that use of the transitional phrase “comprising” in the preamble did not render the following transitional phrase obsolete. Unfortunately, this type of interpretation before an Examiner is not uncommon, but it is promising to see the Board consistently reaching the correct conclusion. See, e.g., (PTAB rejecting an Examiner’s attempt to construe “comprising … a single odorant chamber” to allow for a plurality of chambers).

Judges: G. Best, N. Wilson, M. Cashion, Jr.


October 13, 2021by Beau Burton

Equivalence is a common tool used by Examiners to demonstrate the obviousness of a claimed component that is known to be interchangeable with a component in the prior art. However, Ex parte Breder illustrates that the interchangeability alone is insufficient for obviousness – the context of the equivalence is key. Appeal No. 2021-002289 (PTAB Oct. 5, 2021) (non-precedential).

In Breder, the claims were directed to a method of antagonizing 5-HT7 and 5-HT1B receptor activity in a patient suffering from ADHD by administering viloxazine. The primary reference relied on by the Examiner taught a method of treating ADHD with a norepinephrine reuptake inhibitor reboxetine. The primary reference emphasized the high selectivity of reboxetine for norepinephrine processing and its efficacy for treating ADHD, but said nothing whatsoever about viloxazine.

Attempting to present a prima facie case of obviousness for the treatment of ADHD with viloxazine, the Examiner found a secondary reference that disclosed reboxetine and viloxazine as norepinephrine reuptake inhibitors and alleged that a skilled artisan “would have been motivated to substitute the norepinephrine reuptake inhibitor, viloxazine, … with the norepinephrine reuptake inhibitor, reboxetine, in the method of treating ADHD.” Despite this apparent equivalence, the Board did not agree.

From the Board’s perspective, any functional equivalence between viloxazine and reboxetine as norepinephrine reuptake inhibitors was outweighed by the secondary reference had nothing to do with ADHD. In fact, the secondary reference was directed to a topical composition for the transdermal delivery of active agents for ailments such as muscle pain and muscle cramps, which could optionally include norepinephrine reuptake inhibitors. According to the Board, the “sole nexus between the teaching of [the prior art]” is “that reboxetine and viloxazine are norepinephrine reuptake inhibitors,” and this was not enough.

Simply put, the Board did not agree that an optional ingredient in a topical composition for treating muscle pain provided sufficient motivation for a skilled artisan to replace the reboxetine with viloxazine in a complexly different method for treating ADHD, with a reasonable expectation of success. The primary reference’s emphasis on the high selectivity and efficacy of reboxetine bolstered this conclusion.

Takeaway: Context is key. Functional equivalence can be essential for a prima facie case when the primary reference lacks a claimed component but includes a component known to be interchangeable with it. But as shown by Breder, this functional equivalence will not carry the day when the references being combined have nothing in common. Therefore, it is important to thoroughly assess the purpose and end use of each of the references being combined when an Examiner relies on a theory of functional equivalence for the obviousness of a claimed component.

Judges: R. Lebovitz, J. New, D. Cotta