Jacob Doughty, Author at ElementIP Law

Ex parte Lindenblatt, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing evidence of unexpected results.

In Ex parte Lindenblatt, the claim at issue was directed to a pharmaceutical (thyroid hormone) formulation. The relevant claim recited:

1. A solid pharmaceutical preparation comprising

levothyroxine sodium,

2-10% by weight based on the preparation of gelatine,

0.2 to 3% by weight based on the preparation of citric acid, and

a filler that is 50 to 80% by weight, based on the preparation, of mannitol, sucrose or lactose, and 10 to 30% by weight, based on the preparation, of maize starch.

In rejecting the claim, the examiner relied on a primary reference that disclosed all of the features except for the gelatin. For this deficiency, the examiner relied on a secondary reference disclosing levothyroxine sodium tablets including gelatin and fillers and describing that, when gelatin is used as a binder, the tablets have surprising stability.

Applicant argued that the tablet of the primary reference was intended to dissolve rapidly in a patient’s mouth and, thus a skilled artisan would not have been led by the secondary reference’s promises of stability through the use of gelatin.

The PTAB was not persuaded, finding that the examiner made a prima facie case of obviousness. The PTAB noted particularly that “while [the primary reference] is concerned with a composition that can easily dissolve in the mouth, such does not indicate that [the primary reference] is not interested in a product that has a stable shelf life until inserted into the mouth of a patient.”

The PTAB was persuaded, however, by applicant’s evidence of unexpected results.

First, applicant provided evidence (a journal article) showing that it was known that citric acid is a pH modifier that reduces the stability of levothyroxine sodium in tablets relative to tablets including a basic pH modifier or no pH modifier (at 10% – much higher than the claimed range and the primary reference). Then, applicant supplemented with experimental evidence, which showed the following results for stability when varying citric acid and gelatin amounts in levothyroxine sodium tablets:

Citric Acid	Gelatin	Stability
1.5%	–	★
–	–	★★
–	5%	★★★
1.5%	5%	★★★★

Looking at the evidence, the PTAB found that the stability results for the combination of gelatin and citric acid would have been unexpected, because citric acid alone was reported in the literature and shown in applicant’s experimental results to negatively affect the stabilization of levothyroxine sodium in a tablet. That is, the PTAB concluded that a skilled artisan would not have expected the combination of citric acid and gelatin to provide better stabilization of levothyroxine sodium in a tablet composition than the stabilization provided by gelatin alone.

Takeaway: In this case, the examiner provided a credible reason for expecting that addition of gelatin to the citric acid-containing tablets of the primary reference would increase stability – the secondary reference explicitly stated that stability would be increased. Applicant was able to find literature evidence suggesting that a large amount of citric acid is expected to destabilize. Applicant supplemented this with post-filing results showing that small amounts of citric acid destabilize. Together, this evidence persuaded the PTAB that the improved performance of the citric acid/gelatin combination shown by applicant was unexpected.

Applicant provided a good amount of evidence and a compelling narrative regarding unexpectedness. The PTAB’s explanation, however, gives little weight to the fact that the primary reference tablets already included citric acid. Further, the post-filing evidence regarding the effect of small amounts of citric acid would not have informed a skilled artisan of what would have been expected or unexpected at the time of the application. This case illustrates that sometimes a persuasive story can be useful in overcoming weaknesses in evidence of unexpected results.

Judges: Adams, Jenks, Townsend

Ex parte Slark, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing whether the changes to a prior art composition that would result from an examiner’s proposed modification were sufficiently dramatic to negate obviousness.

In Ex parte Slark, the claim at issue was directed to a hot melt adhesive composition. The relevant claim recited:

A non-reactive hot melt adhesive composition comprising two thermoplastic polyurethane copolymers (A) and (B), wherein

the thermoplastic polyurethane copolymer (A) comprises a reaction product of at least one polyester polyol, and at least one polyisocyanate, and has a number average molecular weight (M_n) of at least 25,000 g/mol;

the thermoplastic polyurethane copolymer (B) comprises a reaction product of at least one polyester polyol, and at least one polyisocyanate, and has a number average molecular weight (M_n) of less than 25,000 g/mol; and

wherein the hot melt adhesive composition has a melt viscosity of 1,000 to 100,000 mPas at 160 °C and

wherein both thermoplastic polyurethane copolymers (A) and (B) are essentially free of NCO groups.

The examiner cited a primary reference that disclosed a solvent-free hot melt adhesive composition including two thermoplastic polyurethane copolymers, each copolymer being a reaction product of at least one polyester polyol and at least one polyisocyanate. The examiner acknowledged that the primary reference failed to disclose that the hot melt adhesive was non-reactive or that the polyurethane copolymers were essentially free of NCO groups. The examiner noted particularly that the preferred ratio of NCO groups to OH groups in the copolymers of the primary reference (>1) would not result in a “non-reactive” composition in which the copolymers were “essentially free of NCO groups.”

To address this deficiency, the examiner turned to a secondary reference. The secondary reference disclosed a solvent-free hot melt adhesive composition including a polyurethane obtained from a polyester polyol and an isocyanate, in which the ratio of NCO groups to OH groups in the polyurethane (~1) resulted in a “non-reactive” composition in which the polyurethane was “essentially free of NCO groups.” The examiner asserted that it would have been obvious to modify the polyurethanes of the primary reference to have the NCO:OH ratio of the polyurethane of the secondary reference, because the secondary reference disclosed that the ratio was suitable for reacting a polyester polyol with a polyisocyanate such that the resulting hot melt adhesive would be essentially free of NCO groups and nonreactive.

Applicant argued over the rejection by relying on two non-obviousness arguments that are explicitly identified in the MPEP: (1) modifying the composition of the primary reference as proposed by the examiner would render the composition “unsatisfactory for its intended purpose” (MPEP 2143.01.V); and (2) modifying the composition of the primary reference as proposed by the examiner would “change the principle of operation” of the composition (MPEP 2143.01.VI).

With respect to (1), applicant argued that the primary reference was directed to a reactive thermoset hot melt adhesive composition – not a non-reactive thermoplastic composition as required by the claims. Applicant noted that the purpose of the primary reference was to provide a moisture reactive polyurethane hot melt adhesive having a particular cured strength and excellent adhesion to metals. Applicant argued that the examiner’s proposed modification would eliminate essentially all of the isocyanate moieties in the prepolymers, rendering them non-reactive and unsatisfactory for the intended purpose of the primary reference. With respect to (2), applicant similarly argued that, because the examiner’s proposed modification involved eliminating the isocyanate groups from the prepolymers, the principle of operation of the composition of the primary reference would be different – the composition would no longer be a reactive, moisture-curable thermosetting polyurethane adhesive composition.

The PTAB agreed with applicant. The PTAB indicated that the “intended purpose” and “principle of operation” of the adhesive composition of the primary reference were intertwined. The examiner attempted to broadly characterize the composition of the primary reference as involving adhesion – an intended purpose and principle of operation that would be preserved even if the examiner’s proposed modification was made. However, the PTAB indicated that the examiner should have considered the contribution of the primary reference to the art when identifying the intended purpose and principle of operation. The PTAB noted that the primary reference expressly stated that mixtures of isocyanate-terminated polyurethanes provide good adhesion to metal substrates by achieving an initial bond strength upon cooling on a substrate and eventually achieving an ultimate bond strength when cured with ambient moisture. The PTAB agreed with applicant that the examiner’s proposed modification would render the composition of the primary reference unsatisfactory for its intended purpose and would change the principle of operation.

Takeaway: When facing obviousness rejections of chemical compositions, it can be difficult to persuade an examiner that he or she has failed to make a prima facie case. Absent a plain oversight by the examiner regarding the scope of the claims or prior art, it is often necessary to significantly narrow the scope of the claims and/or rely on experimental evidence of unexpected results. However, there are legal arguments that can be effective in overcoming obviousness arguments without amendments or experimental results – and the MPEP remains a great source for identifying compelling reasoning for arguing over obviousness rejections.

Judges: Hanlon, Housel, Inglese

Ex parte Ratcliff, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing whether the requirement that a component of a claimed composition “remains stable in the composition” was indefinite.

In Ex parte Ratcliff, the claim at issue was directed to an oral rinse composition. The relevant claim recited:

An oral rinse composition for enhancing tooth remineralization, comprising:

stabilized chlorine dioxide that remains stable in the composition, the stabilized chlorine dioxide capable of reacting with acidic elements of oral biofilms to produce chlorine dioxide gas;

sodium fluoride; and

a pharmaceutically acceptable buffer effective at establishing an effective pH range of the composition from about 6.0 to about 7.4 for maintaining the stability of the chlorine dioxide in the composition;

wherein the stabilized chlorine dioxide and the sodium fluoride in combination are more effective at enhancing tooth remineralization and reducing tooth demineralization than either of the stabilized chlorine dioxide or the sodium fluoride alone.

In this case, the examiner took issue with the above-emphasized phrase “stabilized chlorine dioxide that remains stable in the composition.” Particularly, the examiner asserted that “… the claim does not provide a discernable boundary on what provides the functional characteristic to the stabilized chlorine dioxide (SCD),” wondering whether stabilized chlorine dioxide is stable in the composition:

… due to the addition of some other structure (such as pH modifiers, stabilizers, etc.), absence of destabilizing agents (such as stannous chloride), other features of the composition (such as specific pH ranges)… due to a sequence of steps by which it is made or by some other means, or a certain combination of these.

Applicant argued that “stability” was adequately defined in the specification as the “ability to maintain levels of the… chlorine dioxide source… within the levels specified by the present invention when the final composition is placed under…” specified storage conditions. However, the PTAB noted that the “levels specified by the present invention” were not defined in the claim or specification (or identified by applicant in its appeal briefing).

The PTAB searched the specification for further guidance and found a general disclosure of amounts of the chlorine dioxide source (0.005% w/w to 0.800% w/w) and disclosure that a reduction in the amount of stabilized chlorine dioxide after storage (0.125% w/w >> 0.04% w/w) indicated that stability was achievable. However, the PTAB found that there was insufficient guidance in the specification regarding “how much stabilized chlorine dioxide must remain in the composition after being stored under the specified conditions, in order to be stable according to the definition of stability provided in [the specification].” Thus, the PTAB affirmed the examiner, finding the claim so ambiguous that it failed to inform a skilled artisan about the scope of the claimed invention with reasonable certainty.

The PTAB reversed the only other rejection on appeal – an obviousness rejection. However, this was a pyrrhic victory. The PTAB stated that “the scope of the claimed subject matter is so uncertain that we cannot meaningfully perform the required comparison between the composition recited in [the claim] and the compositions of the cited prior art.”

Takeaway: It was apparent in this case that the PTAB was looking for a number – how much stabilized chlorine dioxide would need to remain in the composition after storing under specified conditions for the stabilized chlorine dioxide to be deemed “stable in the composition”? For claims as in this case, it can be helpful to consider how the difference between “stable” and “not stable” will be explained to a lay jury. If it will be hard to show a lay jury the line between infringing and not infringing, it may be preferable to claim the composition differently (maybe product-by-process).

In this case, both the examiner and the PTAB relied on their own judgment of how a skilled artisan would have viewed the meaning of stability. While applicant provided experimental evidence to show that certain prior art compositions did not include stabilized chlorine dioxide that remains stable, a succinct statement from a skilled artisan regarding how to determine whether stabilized chlorine dioxide “remains stable in the composition” may have framed the issue of indefiniteness in a more favorable manner.

Judges: Adams, Prats, Townsend

Ex parte Hwang, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing whether a claimed sequence of layers was rendered obvious by a similar sequence of layers in the prior art.

In Ex parte Hwang, the claim at issue was directed to a barrier film used to protect a display device, such as a liquid crystal, electronic ink, or organic light emitting diode (OLED) type device. The relevant claim recited, in part:

A barrier film comprising:

a stacked sheet having a top surface and a bottom surface and comprising:

at least two first layers formed of a semicovalent inorganic material; and

at least one second layer formed of an ionic inorganic material,

wherein:

each second layer is disposed between two first layers with one first layer in contact with a first surface of the second layer and the other first layer in contact with an opposite second surface of the second layer,

each first layer and second layer are alternately disposed, the first layers are disposed to form both the top and bottom surfaces of the stacked sheet…

the difference in binding energy between the semicovalent inorganic material and the ionic inorganic material is in the range of 0.1 eV to 3.9 eV…

Thus, the claim was directed to a film including a stack of alternating layers of a first material and second material, with a layer of the first material at the top of the stack and the bottom of the stack:

1—2—1; or

1—2—1—2—1….

In rejecting the claim, the examiner relied on a prior art reference disclosing a similar sequence of layers in a barrier film. However, in the prior art reference, the alternating layers were joined by “anchor coat” layers for “improving interlayer adhesiveness between two layers.” The prior art reference disclosed, for example:

1—AC—2—AC—1

Applicant argued the first layers could not be “in contact” with the second layers because of the presence of the anchor coat layers.

The PTAB noted that the examiner must give broadest reasonable meaning to “contact” and that such term was not defined in the specification. Interestingly, the PTAB noted that applicant added the requirement of contact to the claim during prosecution, relying for support on the description of sequential deposition of first and second layers in an actual example. Ultimately, the PTAB relied on a dictionary definition as providing the conventional meaning of “contact” as requiring a “union or junction of surfaces.”

The PTAB concluded that the examiner had impermissibly read the requirement of contact out of the claim and relied on impermissible hindsight in making the rejection over the prior art reference.

Takeaway: The number of patents that are directed to new sequences of layers of known materials would probably surprise a non-practitioner. There is always a tension between defining sequences of layers concretely to distinguish over prior art and being permissive of additional, intervening layers to avoid a design-around. Terms that are seemingly clear – “on,” “over,” “in sequence,” “in contact” – can be the source of disputes during examination and thereafter (“indirect contact”? “contact via”?). To avoid uncertainty (if this is desired), terms defining relative location should be defined explicitly in the specification and used consistently in the claims.

Judges: Colaianni, Dennett, McGee

Ex parte Ha, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing the sufficiency of an examiner’s rationale for combining references and the sufficiency of an applicant’s evidence of unexpected results.

In Ex parte Ha, the claim at issue was directed to a thermoplastic resin composition for electronic device housing. The claims required, inter alia, five known components in specific amounts and a specific weight ratio between two of the components – a very typical composition claim. Independent claim 1 is reproduced in part below:

1. A thermoplastic resin composition comprising:

about 100 parts by weight of a polycarbonate resin;

about 1 to about 30 parts by weight of a rubber-modified aromatic vinyl graft copolymer;

about 1 to about 30 parts by weight of a polyester resin;

about 1 to about 20 parts by weight of a glycol-modified polyester resin having about 10 mol% to about 60 mol% of a cyclohexanedimethanol (CHDM) content based on a total amount of a diol component; and

about 0.5 to about 15 parts by weight of a vinyl copolymer comprising an epoxy group,

wherein a weight ratio of the polyester resin to the glycol-modified polyester resin

ranges from about 1:0.1 to about 1:1.

The examiner rejected the claim as obvious, citing a primary reference that disclosed a resin composition having each of the above recited features except for the glycol-modified polyester resin and the claimed weight ratio. For this, the examiner relied on the resin composition in a secondary reference.

Applicant noted that the resin composition of the primary reference was developed to solve the problem of achieving flame retardancy in a rubber-modified aromatic vinyl copolymer resin without using harmful compounds and without deteriorating impact strength. Applicant asserted that the secondary reference did not recognize or address issues relating to the use of flame retardants and, thus, a skilled artisan would not look to the secondary reference to improve the resin compositions of the primary reference.

The PTAB found applicant’s reasoning unpersuasive, noting that the secondary reference employed the claimed glycol-modified polyester resin in a resin composition that solved the different problem of achieving improved dimensional stability, heat resistance, and weld line strength. The PTAB stated that a skilled artisan would have found the improved dimensional stability, heat resistance, and weld line strength achieved in the secondary reference to be desirable attributes in the resin compositions of the primary reference and, thus, would have been led to incorporate the glycol-modified polyester resin.

Perhaps recognizing the challenges of arguing over the examiner’s prima facie case of obviousness, applicant relied heavily on rebuttal evidence of unexpected results. Applicant presented supplemental experimental evidence during prosecution showing that excluding the glycol-modified polyester resin of secondary reference from the claimed resin composition and/or including the glycol-modified polyester resin in amounts outside of claimed weight ratio resulted in inferior impact resistance and processibility.

The examiner did not appear to contest that applicant’s results demonstrated that the claimed composition exhibited an improvement over the primary reference or that such improvement would have been unexpected. Instead, the examiner argued that applicant simply did not provide a sufficient number of inventive examples to demonstrate that the improvement would occur over the entire scope of the claims (noting the generic components and wide ranges of amounts recited in the claims).

Applicant affirmatively argued during the appeal that a “skilled artisan… can clearly and reasonably extrapolate or extend the probative value of the data to other compositions within the scope of the claims.” However, the PTAB found applicant’s argument to be merely conclusory, noting applicant’s burden to provide “an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner… as the exemplary embodiment.”

Takeaways: Demonstrating obviousness in the US can be a bit different than in other jurisdictions. Applicant, in this case, presented arguments akin to the “problem-solution approach” used to argue inventive step in EP practice. However, US examiners and the PTAB often find motivation to combine references far afield from the specific problem addressed by the closest prior art. It is important to bring US obviousness arguments to bear against US obviousness rejections.

Because of the ease with which an examiner can make a prima facie case of obviousness as to composition claims, the patentability of such claims often turns on evidence of unexpected results. The sufficiency of such results often turns on whether the results are “commensurate in scope” with the claims. Arguments of unexpected results should be accompanied with at least a technical explanation – preferably from a skilled artisan – of why results for inventive examples would be expected for all compositions within the scope of a claim.

Judges: Gaudette, Cashion, McGee

Ex parte Yim, is a recent decision of the Patent Trial and Appeal Board (PTAB) addressing whether claimed properties were inherent in prior art compositions.

In Ex parte Yim, the claim at issue was directed to a resin. However, the resin was not defined by structure or composition. Instead, only properties of the resin were recited in the claim: (a) content of water-soluble fraction, (b) absorbency against pressure property, and (c) water-soluble fraction shear index property. Independent claim 16 is reproduced in part below:

16. A water-absorbing resin, in which

[a] a content of a water-soluble fraction is 15 wt% or less based on the total weight of the resin,

[b] an absorbency against pressure at 0.3 psi with respect to a saline solution including sodium chloride at 0.9 wt% is 25 g/g or more, and

[c] a water-soluble fraction shear index A/B represented by the following Expression 1 is in a range of 0.1 x 10^-5 (s) to 10 x 10^-5 (s)….

In rejecting the claim, the examiner relied on a single prior art reference that disclosed a water-absorbing resin but did not disclose the properties recited in the claim. Both the prior art reference and the application on appeal disclosed forming water-absorbing polymers by polymerizing and crosslinking an acrylic acid monomer. The examiner asserted that, in view of the similarities in starting materials and processing steps used in the prior art reference and the application on appeal, the properties in the claim were inherent in the water-soluble resins of the prior art reference.

The examiner further asserted that, even if applicant could demonstrate that none of the water-soluble resins exemplified in the prior art reference had the claimed properties, it would have been obvious to tune the reactions in the prior art references to optimize absorbance/solubility characteristics.

The examiner’s inherency arguments turned, particularly, on the examiner’s determination that the prior art reference used two internal crosslinkers to crosslink an acrylic acid, which was the same or similar to the method disclosed in the application on appeal. Applicant countered by arguing, inter alia, that the steps of the prior art method were different such that the two internal crosslinkers were reacted together before being added to acrylic acid, which could not be said to necessarily result in the claimed properties.

The PTAB found that the examiner had made a good argument that the processes of the prior art reference would result in the claimed properties, such that it became applicant’s burden to show that the exemplified resins did not possess the claimed properties. The PTAB also noted that applicant failed to present arguments rebutting the examiner’s fallback assertion that optimizing the properties of the prior art resin would have been a mere matter of routine experimentation to a skilled artisan. Thus, the examiner’s rejection was affirmed.

Takeaway: Parameter or property claims can be valuable in a patent directed to a material or chemical composition. By keeping strict compositional or structural limitations out of a claim, materials or compositions not contemplated at the time of filing may be encompassed by the claim. Further, if claimed parameters/properties are not explicitly disclosed in the prior art, it can be difficult for a third party to confidently analyze the validity of the claim. However, these advantages in a patent claim can be challenges during examination. While some parameter/property claims “sail through” examination, Ex parte Yim shows that an applicant should be prepared to reproduce prior art examples and provide evidence to rebut assertions of routine optimization to obtain allowance.

Judges: Timm, Smith, Range

Intervening rights address the impact on third parties when a patentee makes substantive changes to the scope of patent claims in a post-grant proceeding (reissue, reexamination, AIA trial). Courts have recognized that such changes in claim scope leave “the door … open for gross injustice” when a third party, having already begun to make, use, or sell a given article, finds its previously lawful activities subsequently infringing under a modified patent. Marine Polymer Techs., Inc. v. Hemcon, Inc., 672 F.3d 1350, 1361 (Fed. Cir. 2012).

Intervening rights wholly protect a third party from infringement liability for activity prior to issuance of claims changed in post-grant proceedings (absolute intervening rights). However, whether there is infringement liability for continued activity after issuance of the changed claims is decided by judges (equitable intervening rights). The CAFC recently considered whether a district court properly granted summary judgment as to equitable intervening rights in John Bean Techs. Corp. v. Morris & Assocs., 2020-1090 (Fed. Cir. Feb. 19, 2021).

John Bean was the owner of a patent directed to poultry chillers. Morris sent a letter to John Bean in 2002, arguing that the patent was invalid over prior art. John Bean did not respond, and Morris proceeded to develop and sell poultry chillers. In 2013 – 11 years after Morris sent its letter – John Bean filed a request for ex parte reexamination, which issued with amended claims in 2014. Six weeks after the reexamination certificate issued, John Bean sued Morris. After several years of litigating, the district court granted Morris summary judgment based on its assertion of equitable intervening rights.

In granting summary judgment, the district court considered a number of factors relating to the type and amount of investments in poultry chillers made by Morris before the reexamination certificate issued. Morris noted its “years of research, developments, investments, improvement, promotion, and goodwill associated with the accused product” and conversion of “nearly [two-thirds] of its business to selling the accused product.” John Bean focused on one factor: whether Morris made profits sufficient to recoup its investment. John Bean argued that Morris had fully recouped (and then some) any monetary investment made in reliance on the scope of the claims of the original patent, and this should foreclose the grant of equitable intervening rights.

The CAFC disagreed, stating:

… recoupment is not the sole objective of [the intervening rights statute’s] protection of “investments made or business commenced” before the claims’ alteration… We see no indication in the statute that monetary investments made and recouped before reissue are the only investments that a court may deem sufficient to protect as an equitable remedy.

Noting the district court’s finding that John Bean’s delay was in bad faith, and Morris’s investment was more than just a financial investment, the CAFC affirmed summary judgment. Thus, Morris was permitted to continue unfettered in its poultry chiller business.

Takeaway: Neither patent applicants nor examiners are omniscient, so patentability/validity issues may arise after a patent issues. When considering – or being forced by a third party to consider – post-grant proceedings, it is important to appreciate the risks associated with amending the claims of an issued patent. Of course, the best course of action is to preserve useful, original patent claims. If this is not possible, a patentee should correct defective patent claims with deliberate speed and awareness of the activities of competitors in the marketplace.

Judges: Laurie, Reyna, and Wallach

Ex parte Whalen, is a 2008 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) precedential decisions. Ex parte Whalen, is indicated by the PTAB to be precedential as to “Anticipation – 35 U.S.C. § 102… Inherency… evidence and reasoning” and “Obviousness – 35 U.S.C. § 103… Rationales… optimizing a variable.”

According to the PTAB’s Standard Operating Procedure, “[a] precedential decision is binding Board authority in subsequent matter involving similar facts or issues.”

In Ex parte Whalen, the BPAI considered whether an examiner met his burden in asserting inherency, or alternatively routine optimization, of a claimed viscosity that was not explicitly disclosed in the prior art.

Independent claim 1 was identified as a representative claim:

A composition capable of embolizing an aneurysm at a vascular site comprising:

(a) a biocompatible polymer;

(b) a biocompatible contrast agent wherein a sufficient amount of said contrast agent is employed in said composition to effect visualization in vivo; and

(c) a biocompatible solvent which solubilizes said biocompatible polymer

wherein a sufficient amount of said polymer are [sic] employed in said composition such that, upon delivery to a vascular site, a polymer precipitate forms which embolizes said vascular site; and

further wherein the biocompatible polymer has a molecular weight sufficient to impart to the composition a viscosity of at least about 150 cSt at 40° C.

The claim was rejected as anticipated or obvious over several prior art references. All of the cited prior art references disclosed combinations of components (a), (b), and (c) in compositions for embolizing an aneurysm at a vascular site, but none explicitly disclosed a composition having “a molecular weight sufficient to impart to the composition a viscosity of at least about 150 cSt at 40° C.” The examiner argued that the prior art compositions inherently possessed the claimed viscosity or, alternatively, it would have been obvious to a skilled artisan to “optimize” the prior art compositions by increasing their viscosity to the level recited in the claims.

It was undisputed that the prior art disclosed compositions including components (a), (b), and (c) in amounts overlapping those in the specification and claims of the application on appeal. However, the only disclosure in the prior art of viscosity was of a preferred composition having a viscosity much lower than the viscosity specified in claim 1. The BPAI found that the examiner had not met his burden in establishing inherency. The BPAI stated that, even if some of the compositions encompassed by the prior art’s broad disclosure might have the claimed viscosity, “that possibility is not adequate to support a finding of inherent anticipation.” The BPAI noted that the examiner did not provide evidence or scientific reasoning to show that any specific composition disclosed in the prior art was within the scope of claim 1.

The examiner’s obviousness position rested on the assertion that a skilled artisan would have been motivated to optimize the viscosity of the prior art composition to achieve “the safest clinical outcome and avoiding transvenous passage.” The BPAI noted that the prior art disclosed “adjustment of the viscosity of the composition as necessary for catheter delivery can be readily achieved by mere adjustment of the molecular weight of the copolymer composition.” However, the prior art also disclosed that low viscosity was a desired property in embolic compositions and, as noted above, the only disclosed viscosity in the prior art was much lower than that of claim 1.

Taking the foregoing facts into consideration, and mindful of the Supreme Court’s (then) recent command of “flexibility” in the obviousness inquiry (KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)), the BPAI nonetheless concluded that the examiner had not met his burden. Particularly:

… when the prior art teaches away from the claimed solution as presented here… obviousness cannot be proven merely by showing that a known composition could have been modified by routine experimentation or solely on the expectation of success; it must be shown that those of ordinary skill in the art would have had some apparent reason to modify the known composition in a way that would result in the claimed composition.

That is, the examiner was required but failed to provide an “explanation based on scientific reasoning” that would support the conclusion that a skilled artisan would have considered it obvious to optimize the prior art compositions by increasing their viscosity to the level recited in the claims.

Ex parte Whalen was decided by an expanded five-judge panel, instead of the usual three-judge panel. The Chief Administrative Patent Judge was one of the deciding judges. According to the PTAB’s Standard Operating Procedure, “[a]n expanded panel is not favored and ordinarily will not be used… [a]n expanded panel may be used, where appropriate, to secure and maintain uniformity of the Board’s decisions…”

Takeaway: One of the challenges of prosecuting composition claims (combinations of known components) is the seeming ease with which an examiner can assert that a property not explicitly disclosed in the prior art is inherent and/or would have been readily achieved by a skilled artisan as a matter of routine optimization. Of course, the burden-shifting framework for examination of claims reciting properties is reasonable; however, there remains some burden on the examiner. Rejections based on inherency or routine optimization require that the examiner provide “scientific reasoning” consistent with the overall teaching of the prior art. Conclusory or thinly reasoned assertions of inherency or routine optimization thus provide an avenue for challenge.

Judges: Fleming, Lane, Grimes, Lebovitz, Prats

Ex parte Grillo-Lopez, is a 2020 decision of the Patent Trial and Appeal Board (PTAB) that is listed among the Board’s precedential decisions. Ex parte Grillo-Lopez, is indicated by the PTAB to be precedential as to “[i]ssues specific to ex parte appeals… printed publication.”

According to the PTAB’s Standard Operating Procedure, “[a] precedential decision is binding Board authority in subsequent matter involving similar facts or issues.”

In Ex parte Grillo-Lopez, the PTAB considered a request for rehearing based on applicant’s assertion that the PTAB, in its original decision, improperly affirmed an obviousness rejection relying on the transcript of the July 25, 1997 meeting of the FDA’s Biological Response Modifiers Advisory Committee (FDA Transcript) as a prior art reference (a “printed publication” under pre-AIA 35 USC 102(b)).

Relevant to the discussion: the fact and subject matter of the advisory committee meeting were announced in the Federal Register; a member of the public attended the advisory committee meeting; and the FDA is required by law to prepare a transcript of advisory committee meetings and to make such transcripts available. The FDA Transcript was available in the FDA’s reading room more than one year before the critical date of the application on appeal.

In the PTAB’s original decision, it concluded that the FDA Transcript was made sufficiently accessible to the public interested in subject matter of the claimed invention to render the transcript a printed publication. Applicant countered that the PTAB’s decision was contrary to a prior PTAB decision in which the exact same transcript was found not to be available as prior art.

The PTAB noted that the prior decision finding that the transcript was not prior art related to Inter Partes Review (IPR) proceedings, not ex parte examination. The PTAB noted that, in the IPR proceedings, the burden was on the petitioner to establish that the transcript was prior art, while, in examination, the examiner may shift the burden of demonstrating that a reference is not prior art to the applicant after making a prima facie case. Thus, the PTAB concluded that the prior IPR decisions relating to the transcript did not conflict with the conclusion in its original decision. The PTAB further noted that the Federal Register Notice and the attendance of a member of the public were not in evidence in the prior IPR proceedings.

The PTAB noted applicant’s arguments that the Federal Register notice, the attendance of the member of public, and the legal requirement of preparing the transcript did not prove that the transcript itself was publicly available – applicant argued that someone would have to have been a lawyer – not skilled artisan in the subject matter of the claimed invention – to be aware of, much less find, the FDA Transcript. However, the PTAB found that the established facts, together, were sufficient to establish a prima facie case that a skilled artisan would have been aware of the meeting and aware that a transcript would be available. Thus, it was applicant’s burden to prove with contrary evidence that the transcript was not readily available to a skilled artisan.

Takeaway: This case highlights differences in the burdens of persuasion between post-grant proceedings, like IPRs, and ex parte examination. The burden on a petitioner in an IPR to prove, e.g., that a document is a printed publication, is much higher than the burden on an examiner in ex parte prosecution. Take note of the differing burdens when making arguments based on PTAB precedent during ex parte examination. Further, if an examiner persists in a position for which he/she is only obligated to make a prima facie case, be prepared to supplement your arguments with evidence (e.g., declaration evidence).

Judges: Fredman, Chang, and Cotta

Ex parte Jud, is a 2007 decision of the Board of Patent Appeals and Interferences (BPAI) that is listed among the Patent Trial and Appeal Board’s (PTAB) informative decisions. Ex parte Jud, is indicated by the PTAB to be informative as to “Obviousness – 35 U.S.C. § 103… Person of ordinary skill in the art…evidence considered.”

According to the PTAB’s Standard Operating Procedure, “[i]nformative decisions set forth Board norms that should be followed in most cases, absent justification, although an informative decision is not binding authority on the Board.”

In Ex parte Jud, the BPAI considered a request for rehearing based on applicant’s assertion that the BPAI, in its original decision, did not properly consider the requirement that a determination of the level of ordinary skill in the art must be made to sustain an obviousness rejection.

The BPAI first noted that both 35 USC 103 and the Supreme Court’s decision in Graham v. John Deere Co., 383 U.S. 1 (1966), require a skill-level determination to ensure objectivity in the analysis of obviousness. However, neither the statute nor Graham requires any particular format for the determination. The BPAI posited that this flexibility is intentional.

The BPAI stated that evidence of the level of ordinary skill can be found in applicant’s disclosure, prior art references, and additional testimony, if necessary. The BPAI noted that evidence of the level of ordinary skill in applicant’s own disclosure tends to be indirect and must not be confused with applicant’s own contribution over the prior art. According to the BPAI, prior art references should be given great weight – although prior art references also generally give indirect evidence of the level of ordinary skill, such references are reliable because generally they are prepared without regard for their use in the skill-level determination (in contrast with direct testimony on the level of ordinary skill).

The BPAI noted that direct testimony about the level of ordinary skill could be probative if well-grounded in facts. However, the BPAI cautioned that, during examination, an examiner has little chance to challenge testimony. Further, the BPAI noted that statements of the education/experience level of a skilled artisan and statements that the level ordinary skill is high or low are typically of little probative value.

In making her obviousness rejection in this case, the examiner stated what she believed a skilled artisan would understand based on the references forming the basis of the rejection, without explicitly stating what she believed to be the level of ordinary skill. The BPAI stated that this was sufficient to put applicant on notice of what the examiner thought one of skill in the art would have known and why. The BPAI stated that, procedurally, the examiner’s skill-level findings can be faulted – at most – for failing to be explicitly labeled as such.

The BPAI noted particularly that applicant did not propose alternative findings on the level of ordinary skill and did not explain why the examiner’s determination (even if indirect) resulted in an incorrect obviousness determination. The BPAI concluded that it would not undo the original panel decision in the absence of some indication that reconsideration of the determination of the level of ordinary skill would make a difference in the ultimate outcome.

Ex parte Jud was decided by an expanded seven-judge panel. According to the PTAB’s Standard Operating Procedure, “[a]n expanded panel is not favored and ordinarily will not be used… [a]n expanded panel may be used, where appropriate, to secure and maintain uniformity of the Board’s decisions….”

Takeaway: Determining the level of ordinary skill is a critical part of obviousness analysis, as is clear from the language of 35 USC 103 and the Supreme Court’s articulation of the Graham factors. However, a purely procedural attack on an examiner’s failure to explicitly state the level of ordinary skill is not likely to be fruitful. The Jud decision leaves a path for challenging obviousness rejections based on the level of ordinary skill: (i) applicant should use facts from her own disclosure and the prior art (and possibly expert testimony based on such facts) to correctly define the level of ordinary skill, and (ii) applicant should provide an explanation of why, if viewed properly, the prior art would not have rendered her invention obvious. If an examiner has truly failed to view prior art in the manner that a skilled artisan would, a challenge based on the level of ordinary skill could be productive.

Judges: Fleming, Torczon, Kratz, Timm, Smith, Moore, Linck

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