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October 4, 2022by Matthew Barnet

In Ex parte Makarova (Appeal No. 2022-002730), the examiner rejected the claims as obvious based on a combination of references. The PTAB reversed, finding important differences between two references suggesting they should not be combined in the way proposed by the examiner.

Independent claim 1 recited:

A microfilter comprising:

a single polymer layer formed from an epoxy-based negative photo-definable dry film, wherein the single polymer layer has a flexibility to be disposed on a roll and unrolled; and

a plurality of apertures formed by exposing the single polymer layer to a UV light via an optical mask to obtain a selected shape of said apertures based on said mask, each of said apertures extending through the single polymer layer having said flexibility,

said single polymer layer having said flexibility forming a freestanding unattached microfilter structure with uniform thickness and having said flexibility.

The examiner found that the primary reference (Wolfe) described most of the limitations of claim 1. For example, Wolfe described a particulate filter with regularly spaced micropores, which comprised a single flexible polymer layer formed from a photo-definable dry film (MYLAR). The single polymer layer in Wolfe had flexibility sufficient to be disposed on a roll and unrolled, and its apertures were formed by exposing the single polymer layer to radiation via an optical mask. The single polymer layer also formed a freestanding, unattached microfilter structure with a uniform thickness.

However, the film in Wolfe was not an epoxy-based film, as recited in claim 1. The examiner turned to a secondary reference (DuPont) for this limitation.

The examiner found that DuPont described a flexible epoxy-based negative photo-definable dry film that had excellent thickness uniformity after hot roll lamination. The examiner found that it would have been obvious to substitute the film from DuPont into Wolfe’s system because both references related to microfabricated polymer membrane structures.

The applicant argued that such a substitution would not have been obvious. In particular, the applicant noted that DuPont’s film was “best suited for permanent applications where it is imaged, cured and left on devices” rather than being a freestanding unattached structure as recited in claim 1. Additionally, the excellent thickness uniformity after hot roll lamination in DuPont was premised on the film being laminated to a substrate, rather than being freestanding.

The PTAB sided with the applicant. The PTAB found that “because DuPont specifically indicates that its film is best used while laminated to an underlying substrate, a person of skill in the art would not have thought that film to be a substitute for Wolfe’s freestanding polymeric sheet.” The PTAB concluded that “the Examiner’s rationale as to why a person of skill in the art would have substituted DuPont’s film for Wolfe’s polymeric sheet is not adequately supported by the evidence of record.” Accordingly, the PTAB reversed the obviousness rejection.

Takeaway: Obviousness rejections often involve a primary reference describing most of the claimed elements, with a secondary reference used to fill in gaps in the primary reference. When an examiner takes the position that it would have been obvious to substitute an element from the primary reference with an element from the secondary reference, it is worth challenging that position if there is a good reason not to make such a substitution.

Judges: Housel, Best, Wilson


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September 9, 2022by Jacob Doughty

Ex parte Ihn is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing obviousness and enablement of a claim directed to an organic light-emitting device – particularly to a compound present in the emission layer of the device. Interestingly, the primary reference in the appealed obviousness rejection, Endo, originated from an anonymous third-party submission.

The claim at issue was directed to an organic light-emitting device comprising, inter alia, an emission layer comprising a thermally activated delayed fluorescence (TADF) emitter and a host (two different compounds). The TADF emitter was required to provide particular emission characteristics in use and to have a structure defined by a generic chemical formula.

Endo disclosed specific compounds that were also disclosed in applicant’s specification as TADF emitters. The claim as filed did not require a specific structure for the TADF emitter – merely that the TADF emitter provide the particular emission characteristics. Based on the commonly disclosed compounds, the third-party submitter – and subsequently the examiner – asserted that the claim was unpatentable (identical compounds have identical properties). During prosecution, applicant added the generic chemical formula which excluded the specific compounds disclosed in the primary reference.

The examiner then took the position that a generic formula in Endo encompassed structures falling within the scope of that amended claim, notwithstanding that no specific compound within the scope of the claim was disclosed in Endo. Applicant countered by arguing that the claim required that a linking group be present between, e.g., an indolocarbazole group and a heteroaromatic group:

“… L1 is selected from: a cyclopentane group, a cyclohexane group… a1 is an integer from 1 to 5…”

while the structural formula from Endo relied on by the examiner required a single bond:

.

While the structural formula from Endo showed connection via a single bond, and most of the exemplary compounds in Endo were connected via a single bond, some exemplary compounds in Endo included an aromatic heterocyclic group indirectly attached to an indolocarbazole skeleton by way of a hydrocarbon group. (This was not inconsistent with the description of Endo’s structural formula, in which polycyclic groups having both aromatic and heteroaromatic rings could be “Ar”).

In view Endo’s disclosure of some compounds in which an aromatic heterocyclic group was indirectly attached, the PTAB found that this “… would have indicated to one of ordinary skill in the art that those structures provide the possibly improved delayed fluorescence emission efficiency and appropriate positional relationship for intermolecular conformation Endo desires from the compounds within…” the structural formula. Thus, the obviousness rejection was affirmed.

With respect to enablement, the examiner argued that the claim covered innumerable combinations of TADF emitters and hosts and that it would have required an undue amount of experimentation to identify combinations of TADF emitters and hosts that provided the claimed emission characteristics. The PTAB declined to adopt the examiner’s reasoning with respect to enablement. The PTAB noted that a large amount of experimentation is not necessarily undue, and the examiner had provided no evidence to support her assertion: “[t]he Examiner’s mere assertions to that effect are insufficient to establish a prima facie case of nonenablement.”

Takeaway: Third-party submissions provide mixed results – sometimes an examiner will rely heavily on the submitted information, and other times it seems that the submitted information has not been carefully considered by the examiner. However, in this case, the third-party submission led to a PTAB finding of unpatentability. This case shows that third-party submissions should not be ignored (particularly in view of their relative low cost) as part of a strategy for influencing the scope of a competitor’s patents.

Compounds are often defined in claims with generic formulae encompassing large numbers of specific compounds. This creates a tension between arguing about what the prior art fairly suggests and arguing about what your own specification fairly enables. It is important to take some care when arguing that prior art does not provide sufficient guidance to lead a skilled artisan to a claimed genus of compounds – particularly if the prior art’s disclosure is not significantly less robust than the disclosure of your own specification.

Judges: Owens, Hastings, Range


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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


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August 5, 2022by Matthew Barnet

In Ex parte Whiteman (Appeal No. 2021-003736), the examiner rejected the claims as obvious based on a hypothetical particle distribution consistent with the prior art. The PTAB reversed.

Independent claim 1 recited:

An inorganic particulate material comprising:

equal to or more than about 3 ppm of particles having a particle size equal to or greater than about 25 μm,

equal to or less than about 40 wt% of particles smaller than about 0.75 μm,

having a d98 less than about 11 μm, and

wherein the % of particles smaller than 0.5 μm is equal to or less than about 25 wt%.

Relevant to the appeal, the italicized limitations required that (i) particles smaller than about 0.75 μm made up no more than about 40 wt% of the particle distribution, and (ii) particles smaller than 0.5 μm made up no more than about 25 wt% of the particle distribution. In other words, there could not be a large fraction of very small particles. For example, a distribution in which 50 wt% of particles were smaller than 0.75 μm would be outside the scope of the claims, as would a distribution in which 30 wt% of particles were smaller than 0.5 μm.

The examiner rejected claim 1 as obvious over a single reference (Calhoun). The examiner relied on a d50 value (rather than wt%) in the range of 0.8 to 3 μm in Calhoun. A d50 value of 0.8 μm, for example, would mean that 50% of the particles were smaller than 0.8 μm. The examiner took the position that the d50 value in Calhoun “impl[ied] or at least suggest[ed] that the claimed wt% of <~0.75μm particles is met.” The examiner found that it would have been obvious “to adjust the particles’ size (either by removing undesirably-sized particles and/or agglomerates, grinding too large particles/agglomerates, and/or agglomerating too small particles)…to meet the claimed wt% of <~0.75μm particles.”

The applicant argued that although Calhoun described a d50 value in the range of 0.8 to 3 μm, the reference said nothing about the fraction of particles smaller than 0.75 μm, or smaller than 0.5 μm, as recited in claim 1. The applicant argued that the examiner had created “a convoluted hypothetical” particle distribution from Calhoun, in which a d50 value of 0.8 μm could be satisfied by 40 wt% of the particles being smaller than 0.75 μm (according to claim 1), and 10 wt% of the particles being between 0.75 and 0.80 μm. Although such a hypothetical particle distribution might have been consistent with the d50 value in Calhoun, the applicant argued that this hypothetical particle distribution was in no way disclosed or suggested by Calhoun.

The PTAB sided with the applicant. The PTAB found that Calhoun’s d50 value of 0.8 to 3 μm “neither discloses nor suggests anything about the particular percentage of particles smaller than about 0.75 μm or smaller than 0.5 μm.” The PTAB found that the “[e]xaminer assumes without providing sufficient evidence that Calhoun’s preferred particulate product having a d50 of 0.8-3 μm contains ‘smaller portion[s] within’ the product, which meet the claimed particular product size distributions.” Accordingly, the PTAB reversed the obviousness rejection.

Takeaway: Obviousness cannot be based on speculation. If a U.S. examiner finds a claimed feature to be obvious over prior art describing a somewhat related, but different feature, the examiner must provide supporting evidence instead of mere speculation. If, as in Ex parte Whiteman, the examiner speculates about a “convoluted hypothetical” feature that is consistent with the prior art – but is not disclosed or suggested by the prior art – it is worth challenging the examiner’s position.

Judges: Colaianni, Dennett, McGee


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July 28, 2022by Richard Treanor

Last December, in Modernatx, Inc. v. Arbutus Biopharma Corp., 18 F.4th 1364 (Fed. Cir. 2021), Moderna, in appealing their challenge to an Arbutus patent in an inter partes review, contended that the Board had erred in dismissing their case because it failed to apply a presumption of obviousness based on overlapping ranges in the prior art. While Moderna admitted that not all of the claimed ranges of the Arbutus components were explicitly disclosed in their cited art, they contended that the single missing range could be calculated based on the other ranges and on the “axiomatic” concept that the total of all components must be 100%. The Federal Circuit disagreed.

While the court acknowledged that it had, in the past, found that a presumption of obviousness exists “when the ranges of a claimed composition overlap the ranges disclosed in the prior art,” it found that, in this case, it was undisputed that a range for one of the components was not expressly “disclosed.” Recognizing that it was also true that the court had never affirmatively decided whether the presumption could apply in a case such as this, the court nevertheless declined to make that decision here “because this case turns on a narrower issue, specifically, Moderna’s failure to show that the overlapping range is actually taught by the prior art.”

In dismissing Moderna’s seemingly reasonable theory of overlapping ranges using a calculated missing range the court found that “[o]ne of the key flawed assumptions that Moderna makes is that the amount of each individual … component in the prior art … can be freely manipulated and adjusted across the full scope of the disclosed ranges” and that, as a corollary, Moderna “assumes that any … component … can be increased as long as any … component … is decreased by a corresponding amount to maintain a total of 100%.” The court came to this position because Arbutus had put forth a “plethora of evidence, including evidence from the prior art references as well as expert testimony” demonstrating that “this case is not that simple because the … components … are interdependent, … they interact with each other unpredictably” and “as a whole, rather than on any one component.” The court then reminded Moderna that even in prior cases with fully, explicitly disclosed overlapping ranges involving multiple components “we have held that evidence that the components interacted in an unpredictable or unexpected way could render the combination nonobvious,” emphasizing in the opinion that such earlier holdings apply even more strongly here, where Moderna’s assumptions necessary to derive the unstated/implicit overlapping range are themselves undermined by the unpredictable interactivity between the components.

Takeaway: Because a rejection involving overlapping ranges can give rise to a presumption of unpatentability which puts the burden of going forward on applicant/patentee, it must be vigorously contested. The several ways in which Arbutus “fought off” the presumption in the Moderna case provide an instructive framework for traversing such rejections.

Judges: LOURIE, O’MALLEY, and STOLL


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July 15, 2022by Jacob Doughty

LG Elecs. v. Immervision, Inc., No. 2021-2037 (Fed. Cir. July 11, 2022), is a recent decision of the Federal Circuit, considering whether errant information in a prior art reference can be relied upon to demonstrate unpatentability.

LGE challenged an Immervision patent directed to capturing digital panoramic images in an IPR. The Immervision patent claimed, inter alia, a method in which, “… the objective lens compresses the center of the image and the edges of the image and expands an intermediate zone of the image located between the center and the edges of the image.”

In challenging the patent, LGE relied on a prior art U.S. patent, Tada, which did not expressly disclose compressing the center and edges of an image and expanding an intermediate zone, but which included tables setting forth various measurements of specific embodiments of the disclosed lens system. LGE retained an expert who performed calculations based on the measurements and concluded that one of the lens systems of Tada (Embodiment 3) compressed the center and edges of an image and expanded an intermediate zone.

Immervision also retained an expert, who, in the course of performing his own calculations, discovered discrepancies in the measurements for Embodiment 3 of Tada. After some detailed examination of other embodiments of Tada and the Japanese patent application from which priority was claimed, Immervision’s expert determined that the measurements for Embodiment 3 shown in Tada erroneously included measurements for a different embodiment.

That is, due to an apparent cutting-and-pasting error in translating the Japanese application on which Tada was based, LGE’s expert’s calculations indicated that the lens system of Embodiment 3 of Tada compressed the center and edges of an image and expanded an intermediate zone. However, if LGE’s expert had used the correct measurements, this would not have been the case.

Based on the testimony of Immervision’s expert, the PTAB concluded that LGE failed to carry its burden in demonstrating unpatentability. LGE appealed.

The Federal Circuit noted that “… the standard for evaluating these types of apparent or ‘obvious typographical error[s],’” is set forth in a decision of its predecessor court, more than 50 years ago, in In re Yale, 434 F.2d 666 (C.C.P.A. 1970). Particularly:

The court in Yale held that where a prior art reference includes an obvious error of a typographical or similar nature that would be apparent to one of ordinary skill in the art who would mentally disregard the errant information as a misprint or mentally substitute it for the correct information, the errant information cannot be said to disclose subject matter.

In Yale, the CCPA concluded that a reference could not be relied on for disclosing a compound that appeared in a single instance due to an error (CF3CHClBr was shown as CF3CF2CHClBr in a graph).

LGE argued that the error in Tada could not possibly be an obvious error because it took Immervision’s expert hours of detailed investigation to find. LGE further argued that the error in Tada was not “of a typographical or similar nature.” The Federal Circuit was not persuaded. In affirming the PTAB, the Federal Circuit noted that the length of time and manner in which an error was discovered did not diminish its obviousness. Further, the Federal Circuit further stated that “[t]he distinction between the typographical error in Yale and the copy-and-paste error here is a distinction without a difference.”

In dissent, Judge Newman was more sympathetic to LGE’s position:

I agree with the panel majority that Yale establishes the correct standard to determine if an error would be obvious to a person of ordinary skill in the field. However, I do not agree with the majority’s application of this standard to the facts herein. An “obvious error” should be apparent on its face and should not require the conduct of experiments or a search for possibly conflicting information to determine whether error exists. When a reference contains an erroneous teaching, its value as prior art must be determined.

Takeaway: It is not uncommon for technical documents relied on as prior art (e.g., patent publications, journal articles) to include errors – particularly in descriptions of experimental results. Such errors may undermine an assertion that a property or parameter is inherent – and thus possibly provide an avenue for attacking a prior art rejection or assertion of invalidity.

Judges: Newman (dissenting in part), Stoll, Cunningham


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July 8, 2022by Yanhong Hu

Ex parte Deporter (Appeal 2021-003598) is a recent decision of the Patent Trial and Appeal Board (“Board”) where the Board considered whether a prior art reference taught away from Appellant’s claimed invention.

The claim at issue was directed to a composite structure of at least one spunbonded, nonwoven, polymeric layer and at least one meltblown, nonwoven, polymeric layer. The Examiner found that the primary reference, Moore, disclosed each element of the claim except that Moore did not teach “at least one of the spunbonded layers comprises inorganic particulate filler in an amount from about 12% by weight to about 16% by weight of the spunbonded layer.” The Examiner found that the secondary reference, McAmish, taught nonwoven fabrics of spunbonded polymeric fibers which contained fillers such as calcium carbonate particles in an amount of about 10-15 wt% and the associated advantages. The Examiner thus determined it would have been obvious to use from 10-15 wt% of filler in one of Moore’s spunbonded layers as motivated by the advantages described in McAmish.

Appellant argued that there would be no motivation to modify Moore’s structure using McAmish’s amount of filler because Moore taught away from using so much filler. In particular, as noted by Appellant, Moore disclosed that “[f]illers, plasticizers, and other additives, when used at levels above 3% by weight, and more certainly above 5% by weight of the aliphatic polyester, can have a significant negative effect on physical properties such as tensile strength of the nonwoven web. Above 10% by weight of the aliphatic polyester resin, these optional additives can have a dramatic negative effect on physical properties.”

However, Moore also disclosed that “total optional additives including any particulate phase other than antishrinkage additive, preferably are present at no more than 10% by weight, preferably no more than 5% by weight and, most preferably no more than 3% by weight.” Based on such disclosure, the Examiner contended that Moore “does not … expressly teach away from the combination [of Moore and McAmish]” because “Moore acknowledges fillers as high as 10%.”

The Board acknowledged that “[in] some circumstances, the use of the word ‘preferably’ in this context might militate against a finding of teaching away.” However, the Board found that Moore’s specific statement that using above 10% by weight “can have a dramatic negative effect on physical properties” was “direct and specific enough” to outweigh the possibility that “a person of skill in the art might see the word ‘preferably’ and consider using more than 10% of filler.”

Therefore, the Board agreed with Appellant that Moore taught away from using 12-16% by weight of an inorganic particulate filler in at least one of the spunbonded layers and reversed the Examiner’s obviousness rejection.

Takeaway:  Teaching away from an applicant’s claimed invention is a strong indication that it would not have been obvious. Teaching away can be found in a situation where a reference criticizes, discredits, or otherwise discourages the route the applicant takes. However, it is also well-settled that the indication that a certain embodiment is a preferred embodiment is not a teaching away. Deporter is a case where the two situations coexist. It illustrates that “teaching away” is still an effective rebuttal argument for patentees, especially when a reference specifically and directly discourages the alleged modification.

Judges:  B. A. Franklin, G. C. Best, and N. W. Wilson


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June 27, 2022by Matthew Barnet

In Ex parte Jung (Appeal No. 2021-003163), the examiner rejected the claims as obvious based on an inherency rationale. The PTAB reversed.

Independent claim 16 recited an inkjet set consisting of:

a black inkjet ink, a cyan inkjet ink, and two inkjet inks A and B… wherein

the inkjet ink A has a hue angle H* between 70 and 85 and a chroma C* between 30 and 80;

the inkjet ink B has a hue angle H* between 20 and 40 and a chroma C* between 30 and 80 …

The dispositive issue on appeal was whether the hue angle H* and chroma C* were inherent in the applied art.

The examiner cited a reference broadly disclosing mixtures of pigments, and including the specific pigments C.I. Pigment Orange 71, C.I. Pigment Yellow 139, C.I. Pigment Red 254, and C.I. Pigment Red 122 among a long list of suitable pigments. The examiner noted that these specific pigments were recited in the applicant’s dependent claims 19 and 21. Based on this, the examiner took the position that if these specific pigments were selected in the reference, the resulting inks “would intrinsically [i.e., inherently] have” the claimed H* and C* values.

The applicant argued that even if the specific pigments were selected in the reference, the claimed H* and C* values would not necessarily result. The applicant stated that these limitations “are not only achieved by selecting specific pigments, but also by the amounts of the pigments used and the weight ratio of the different pigments in the mixture.” Additionally, the applicant provided calculations of H* and C* values resulting from the examples of the reference, showing them to fall outside the claimed ranges. However, the examiner dismissed these calculations as “attorney argument and not evidence.”

The PTAB sided with the applicant. The PTAB found that “the use of the recited pigments alone is not adequate to guarantee that the H* and C* limitations are met” and that the ratio of different pigments mattered. Regarding the calculations provided by the applicant, the PTAB found that the examiner dismissed them in error (“There is no dispute that the calculations are based on examples disclosed by [the reference], and there is no dispute as to the accuracy of the calculations. Because [the reference] itself is evidence, the calculations made using the data from [its] examples should not have been disregarded as mere ‘attorney arguments.’”).

The PTAB acknowledged that the claims still might have been obvious if the reference “teaches or suggests combining pigments in a way (e.g., optimizing the weight ratios of different pigments) that would have resulted in H* and C* values within the scope of claim 16.” However, the PTAB found no such teaching or suggestion. While the reference taught that the pigments or mixture of pigments be present “in an amount of 0.1 to 20% by weight based on the total weight of the non-aqueous inkjet ink,” the reference provided no teaching or suggestion for weight ratios among different pigments. Accordingly, the PTAB reversed the obviousness rejection.

Takeaway: Whenever an examiner takes the position that a claimed property is inherent in the applied art, it is important to carefully evaluate embodiments of the applied art that might result in the claimed property. Inherency requires necessity, not merely possibility. That is, just because it might be possible for the applied art to satisfy a claimed property, that does not mean that the applied art necessarily satisfies the property. If the prior art does not necessarily satisfy the claimed property, then inherency has not been established.

Judges: Abraham, Kennedy, Gupta


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June 1, 2022by Richard Treanor

On February 28, 2022, the Patent Trial and Appeal Board (PTAB) issued a decision in Ex parte Chen (Appeal 2021-001752) affirming an Examiner’s rejection of claims directed to a polyisocyanurate foam composition comprising a certain two-component blowing agent.

In making the rejection, the Examiner used the same technique used in Almirall, LLC v. Amneal Pharm., No. 2020-2331 (Fed. Cir. Mar. 14, 2022) (discussed here) – she applied a primary reference disclosing one of the claimed blowing agent components and combined it with a secondary reference disclosing an expansive laundry list of blowing agent components that partially overlapped with species described in the primary reference and which, importantly, included the claimed blowing agent component missing from the primary reference. In justifying the combination, the Examiner took the position that because all the blowing agent components in the laundry list were “interchangeable and equivalent” it would have been obvious to substitute one of the overlapping components in the primary reference with the missing component.

Applicant traversed the rejection in three different ways in their Brief. First, they argued that neither reference, on its own, rendered the claims obvious (never a good idea in an obviousness rejection based on two references). Next, they asserted that because the primary and secondary references focused on different types of blowing agents one of ordinary skill in the art would not have combined the references. And finally, they argued that the data submitted during prosecution showed unexpected synergy for their blowing agent composition at their claimed ratios.

The Board, in its decision affirming the Examiner, ignored the first argument, rejected the second argument as lacking evidence and support, and found the data submitted during prosecution to be insufficient because it did not show the beneficial trend asserted and was not commensurate in scope with the claims.

Takeaway: Unfortunately, and as we learned in our prior blog on Almirall, where Applicant went wrong in this case was in not fleshing out its non-combinability argument. The primary and secondary references did indeed focus on different types of blowing agents – saturated v. unsaturated. A declaration explaining why the co-blowing agents listed in each reference were specially tailored for use with only one of these types of agents, and an explanation why only the few overlapping agents could be used with both types, might well have overcome the rejection.

Judges: J. Robertson, M. Cashion, Jr., S. McGee


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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