Takeaway: A declaration that alleges a particular feature would have been obvious to an ordinary artisan but fails to provide sufficient explanation for why it would have been obvious to the ordinary artisan, may not be afforded any consideration by the Board regarding the obviousness of that feature.

In its Decision, the Board denied institution of inter partes review of claims 13, 33, 39, 45, 52, 59, 66, 73, 83, 89, 95-108, 117, and 118 of the ’167 patent because Petitioner did not demonstrate a reasonable likelihood of prevailing with respect to any of the challenged claims.

The ’167 patent relates to edible water-soluble delivery systems in the form of a film composition including a water-soluble polymer, an active component selected from cosmetic agents, pharmaceutical agents, vitamins, bioactive agents, and combinations thereof, and at least one anti-tacking agent. The ’167 patent addresses the issue of particle agglomeration and its associated non-uniform distribution of therapeutic agent within film dosage forms by using a selected casting or deposition method or a controlled drying process.

Petitioner alleged: (1) anticipation of claims 13, 33, 39, 45, 52, 59, 66, 73, 83, 89, 95-108, 117, and 118 by Chen, (2) obviousness of claims 13, 33, 39, 45, 52, 59, 66, 73, 83, 89, 95-108, 117, and 118 over Chen, (3) obviousness of 13, 33, 39, 45, 52, 59, 66, 73, 83, 89, 95-108, 117, and 118 over Chen in view of Leung, (4) obviousness of claims 13, 33, 39, 45, 52, 59, 66, 73, 83, 89, 95-108, 117, and 118 over Chen in view of Leung and Modern Coating, (5) anticipation of claims 13, 33, 39, 45, 52, 59, 66, 73, 83, 89, 95-108, 117, and 118 by Tapolsky, (6) obviousness of claims 13, 33, 45, 52, 66, 73, 83, 89, 95, 96, 98, 101-103, 106, 108, 117, and 118 in over Tapolsky, and (7) obviousness of claims 13, 33, 39, 45, 52, 59, 66, 73, 83, 89, 95-108, 117, and 118 over Tapolsky in view of Modern Coating.

The Board agreed with Petitioner’s construction of “substantially uniform distribution” because it is consistent with language used in independent claims 13 and 95. However, the Board disagreed with Petitioner’s contention that the claims do not recite any conditions on the term “controlled drying process.” The Board construed the term “controlled drying process” as referring to drying with at least one controlled drying parameter, which forms a viscoelastic matrix within a few minutes of the drying process to lock-in the active component within the matrix, and maintains a “substantially uniform distribution” of the active component so that substantially equally-sized individual unit doses do not vary by more than 10% of the desired amount of the active component.

Petitioner alleged that Chen’s films include (1) an ingestible water soluble polymer matrix described by Chen as a hydrocolloid, and (2) sodium benzoate and vitamin E, inter alia, as a preservative and stabilizer, respectively. Petitioner argued that Example 1 of Chen discloses that the active component is substantially uniformly distributed, as measured by substantially equal-sized individual unit doses that do not vary by more than 10 % of the desired amount of the active component. Petitioner alleges that Example 1 reports weights to two significant digits and results in a consistent 0.03 g per film dosage with a variation of 0%. The Board concluded that Example 1 does not disclose all of the limitations recited in independent claims 13 and 95. The Board noted that Example 1 does not include vitamin E, or sodium benzoate, as required by claim 13, or the specific polymers (other than HPMC) and sodium benzoate, as required by claim 95. Petitioner argued that during reexamination of the ’588 patent, which is from the same family of patents as the ’167 patent, the Board had found that having a weight deviation of ± 0.001 is well within the less than 10% variation of active content per film unit.   The Board noted that it had upheld the Examiner’s finding of inherency in relation to a “substantially uniform content” claim limitation at issue in the reexamined claims. The Board concluded that even if it had adopted Petitioner’s arguments regarding the statements by the Board during the ’588 patent reexamination, Petitioner failed to establish that Chen discloses all of the features recited in claims 13 and 95.

Petitioner next argued that the challenged claims are obvious in view of Chen. Petitioner argued that achieving and maintaining uniformity by controlling the drying process was well known prior to the ’167 patent. Petitioner, citing the Cohen Declaration, alleged that an ordinary artisan would have been able to optimize drying variables in the drying process to produce a high degree of uniformity. Petitioner alleged that that the ordinary artisan would have been motivated to adjust the film manufacturing process to produce film featuring a distribution of active component that does not vary by more than 10% of the desired amount. The Board stated that Petitioner failed to explain adequately why an ordinary artisan reading Chen would have been motivated to prepare a film having the specific polymers and specific anti-tacking agents recited in claims 13 and 95. Petitioner had also failed to demonstrate that films produced from a combination of Chen and the expert testimony would have exhibited necessarily the substantial uniform distribution of claims 13 and 95. The Board also concluded that Petitioner failed to explain adequately why an ordinary artisan would have selected the recited components from Chen’s lists of components in combination. Thus, the Board concluded that Petitioner has not shown a reasonable likelihood of prevailing in its obviousness challenge based on Chen.

Similarly, Petitioner’s obviousness challenges based on the combination of Chen and Leung or Chen, Leung, and Modern Coating were met unfavorably by the Board. The Board concluded that Leung and/or Modern Coating failed to remedy the deficiencies of Chen.

Petitioner argued that Tapolsky anticipated the challenged claims. Petitioner argued that the reported degree of certainty in Example 37 of Tapolsky for albuterol sulfate, 1.46 mg/cm2, indicates that the greatest variation in active component between equally-sized individual unit doses of Tapolsky’s film that could exist given the reported value is well within the variation limitation of claims 13 or 95. While Tapolsky describes the concentration of albuterol sulfate, the Board concluded that Petitioner failed to show where Tapolsky describes albuterol sulfate as uniformly distributed within the film prepared in Example 37. Thus, the Board concluded that Petitioner had not shown a reasonable likelihood of prevailing in its anticipation challenge based on Tapolsky.

Petitioner also alleged that a process for making films with active components that vary by no more than 10% would have been obvious to an ordinary artisan. The Board noted that Petitioner’s statement is merely conclusory. Petitioner cited the Cohen Declaration. The Board noted that none of the Cohen Declaration explains why an ordinary artisan would have considered obvious a film having the “substantially uniform distribution” feature. The Board declined to import the discussion regarding obviousness from the declarations of Petitioner’s expert in the Petition simply because Petitioner cited certain paragraphs within the declarations. Moreover, the Board stated that Cohen’s statements failed to explain which specific variables of Tapolsky’s processes would have been optimized or critical to producing the “substantially uniform distribution” required in claims 13 and 95. Petitioner’s obviousness challenge based on Tapolsky and Modern Coating failed because Petitioner did not explain with adequate specificity which particular variables of Tapolsky’s processes would have been optimized or would have been critical to producing a film having a “substantially uniform distribution” of an active agent as required by claims 13 and 95.

Biodelivery Sciences International, Inc. v. Monosol RX, LLC, IPR2015-00167

Paper 6: Decision Denying Institution of Inter Partes Review

Dated: May 20, 2015

Patent 8,765,167

Before: Francisco C. Prats, Jacqueline Wright Bonilla, and Zhenyu Yang

Written by: Bonilla