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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`———————
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`———————
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`ETON PHARMACEUTICALS, INC.,
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`Petitioner
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`v.
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`EXELA PHARMA SCIENCES, LLC,
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`Patent Owner
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`———————
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`U.S. PATENT NO. 10,653,719
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`PGR2020-00086
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`PETITIONER’S REQUEST FOR REHEARING
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`I.
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`INTRODUCTION
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`Pursuant to 37 C.F.R. § 42.71(d), Petitioner requests rehearing of the Board’s
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`decision denying post grant review entered April 23, 2021 (Paper 11, hereinafter
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`“Decision”).1
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`II. BASIS FOR REHEARING
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`A request for rehearing “must specifically identify all matters the party
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`believes the Board misapprehended or overlooked, and the place where each such
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`matter was previously addressed in a motion, opposition, or reply.” 37 C.F.R. §
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`42.71(d). The Board will review the decision for an abuse of discretion. 37 C.F.R.
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`§ 42.71(c). An abuse of discretion results from an erroneous interpretation of law,
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`a factual finding that is not supported by substantial evidence, or if the decision
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`represents an unreasonable judgment in weighing the relevant evidence. Blue Coat
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`Systems, Inc. v. Finjan, Inc., IPR2016-01444, Paper 11 at 2 (P.T.A.B. July 18, 2017).
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`
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`Respectfully, the Decision’s conclusion that the Petition allegedly failed to
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`demonstrate a reasonable expectation of success in achieving the claimed aluminum
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`1 On December 18 and 22, 2020, respectively, Petitioner requested re-hearings in
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`post-grant reviews of related patents, U.S. Patent Nos. 10,478,453 and 10,583,155,
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`for which the Board previously denied institution. Both of those requests for re-
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`hearing are currently pending.
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`1
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`levels is based upon both a misapprehension of the Petition and findings that either
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`lack substantial evidentiary support or are based upon an unreasonable judgment of
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`the allegedly conflicting evidence in three fundamental respects, any one of which
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`standing alone warrants rehearing and institution of post-grant review.
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`A. Error No. 1: The Reasonable Expectation of Success
`Argument is Not New
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`In refusing to address the Petition’s straightforward analysis that a POSITA
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`would have had a reasonable expectation of achieving the claimed aluminum levels
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`by simply removing the known sources of aluminum contamination from the Sandoz
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`Label product, the decision erroneously concludes that this is a “new argument” that
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`is not found in the Petition. Paper 11 at 23, n. 7. That finding is demonstrably
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`incorrect, as illustrated below.
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`The Petition at Section VIII.C.2, which is titled “The Sources of Aluminum
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`Contamination Were Well-Known and Easily Rectified,” not only identifies known
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`sources of aluminum contamination in parenteral drug products (e.g. the drug
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`product ingredients and the container closure system), but also that the POSITA
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`would have addressed these known sources by using raw materials and
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`manufacturing process substantially free of aluminum and a container closure
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`system that did not leach aluminum into the final drug product. Paper 1 at 32. The
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`Petition also expressly states at Section VIII.C.2: “By addressing and eliminating
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`these known sources of aluminum contamination, the POSITA would have had a
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`2
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`
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`reasonable expectation of substantially reducing and eliminating aluminum during
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`manufacture and storage of the drug product.” (citations omitted). Id. at 32-33.
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`Later, at Section VIII.E. tilted “Claims 1-30 Are Unpatentable,” the Petition
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`3
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`
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`expressly states in the fifth and sixth bullet points:
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`Id. at 38-39. This same Section of the Petition then states:
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`Id. at 39-40.
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`In connection with claim limitation 1[c] (the “less than about 150 ppb of
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`aluminum” limitation), the Petition again explains the reasonable expectation of
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`4
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`
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`success in optimizing the Sandoz Label product to achieve the claimed aluminum
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`levels, i.e., a result-effective variable for solving a known problem:
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`
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`
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`(citations omitted). Id. at 43-44.
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`
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`Thus, the Petition asserts that the POSITA would have had a reasonable
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`expectation of achieving the claimed aluminum levels by optimizing the Sandoz
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`Label product to reduce the known sources of aluminum contamination.
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`B.
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`Error No. 2: The Petition Does Not Suffer From A Lack of
`Particularity
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`
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`The Decision erroneously accepted PO’s accusation that the Petition lacks
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`5
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`
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`particularity because it allegedly “‘improperly mixes-and-matches two different
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`types of alleged prior art [i.e., the Sandoz Label printed publication with the Sandoz
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`product that was sold in association with the Sandoz Label]” in attempt to “back-
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`door unproven” aluminum levels to the Sandoz Label. Paper 11 at 16. Not so. The
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`Decision conflates the Sandoz Label with the Knowledge possessed by the POSITA,
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`both of which are pertinent to Ground 1. Ground 1 is based upon the disclosure of
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`the Sandoz Label (i.e., the printed publication) in combination with the Knowledge
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`of the POSITA, which includes, among other things, the attributes of the Sandoz L-
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`cysteine product that was sold in association with the Sandoz Label (Paper 1 at 28)
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`– attributes which the POSITA could have readily ascertained. The Petition does
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`not treat the Sandoz Label and its associated product as a “single prior art source”
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`nor does the Petition attempt to “back-door [allegedly] unproven [aluminum levels]”
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`from the product into the disclosure of the Sandoz Label. To the contrary, the
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`Petition relies on the plain language of the Sandoz Label, which discloses “[c]ontains
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`no more than 5,000 [ppb] of aluminum.” As the Petition contends, the POSITA
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`would have interpreted the “no more than 5,000 [ppb]” as disclosing a range between
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`0-5,000 ppb aluminum during the product’s shelf-life (Paper 1 at 27), which
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`encompasses the claimed ranges. However, as noted above, the Petition also
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`explained that the POSITA would have had a reasonable expectation of optimizing
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`the product disclosed by the Sandoz Label (as well as the product sold in association
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`6
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`
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`with the Sandoz Label) to have the claimed aluminum levels by merely removing
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`the known sources of aluminum contamination, regardless of the aluminum levels
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`disclosed by the Sandoz Label or found in the product sold in association with the
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`Sandoz Label.
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`
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`Thus, the Petition does not attempt (nor did it need) to back-fill the aluminum
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`levels taught by the Sandoz Label with the levels found in the product that was sold
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`in association with the Sandoz Label. And, more to the point, Ground 1 is clearly
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`based upon the Sandoz Label printed publication in combination with the knowledge
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`possessed by the POSITA, which includes, among other things, the attributes of the
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`product sold in association with the Sandoz Label.
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`C. Error No. 3: The Sandoz Label Encompasses the Claimed
`Aluminum Range
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`
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`Finally, the Decision’s finding that the Sandoz Label’s disclosure of “contains
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`no more than 5,000 [ppb] of aluminum” does not encompass the claimed 1-150 ppb
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`aluminum range lacks substantial evidence and is based upon an unreasonable
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`judgment of the evidence that the Decision considered. Paper 11 at 17. In reaching
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`this conclusion, the Decision reviewed the Sandoz Label in a vacuum without
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`reference to the knowledge possessed by the POSITA, holding that “no more than
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`5,000” recites the maximum level at product expiration and not a range. Id. at 19-
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`20. However, the Decision overlooks that the disclosure of a maximum of 5,000
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`ppb at product expiration is entirely consistent with disclosure of a range below
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`7
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`
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`5,000 ppb during the product’s shelf-life, i.e. prior to the product’s expiration date.
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`As the unrebutted evidence demonstrates, the POSITA would have understood that
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`the aluminum levels in parenteral products such as, for example, the product
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`disclosed by the Sandoz Label gradually increase over the product’s shelf-life,
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`because it was known that aluminum leaches into the drug product from the closure
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`system. Paper 1 at 33.2 Armed with the knowledge that aluminum levels increase
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`during the product’s shelf-life, the POSITA would have interpreted the Sandoz
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`Label’s disclosure of a 5,000 ppb maximum aluminum level at product expiration
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`means that the aluminum levels were below 5,000 ppb pre-expiration, during the
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`product’s shelf-life. Thus, according to Dr. Rabinow, the POSITA would have
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`interpreted the Sandoz Label’s teaching to include aluminum levels ranging between
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`0 to 5,000 ppb over the product’s shelf-life. Id. at 38, 42. Indeed, as the Decision
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`notes, the ’719 patent itself acknowledges that “known L-cysteine compositions
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`contain up to 5000 ppb Aluminum.” Paper 11 at 4 (emphasis added). “Up to 5000
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`ppb” plainly includes levels below 5000 ppb and further corroborates the
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`reasonableness of Dr. Rabinow’s opinion of how the POSITA would have
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`2 PO’s technical expert agrees that it was known that the aluminum content of L-
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`cysteine hydrochloride solutions packaged in glass containers increases over time.
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`Ex. 2001, ¶22.
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`8
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`
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`interpreted the Sandoz Label. Thus, even if, as the Decision concludes, the POSITA
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`would not have interpreted “no more than 5,000” to necessarily include “zero”
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`aluminum, the POSITA would have understood the Sandoz Label’s disclosure of
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`“no more than 5,000 [ppb]” at product expiration to include levels below 5,000 ppb
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`pre-expiration, during the product’s shelf-life. Aluminum levels ranging below and
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`up to a maximum of 5,000 ppb (even if, according to the Decision, not encompassing
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`zero ppb) encompasses the claimed 1-150 ppb aluminum levels (which range does
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`not include “zero”).
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`Indeed, PO does not directly rebut Dr. Rabinow’s opinion that the POSITA
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`would have interpreted the “no more than 5,000 [ppb]” disclosure of the Sandoz
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`Label to encompass the claimed aluminum ranges. PO’s expert, Dr. Kuhn, does not
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`squarely address how the POSITA would have interpreted the Sandoz label, but
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`instead answers a different (and irrelevant) question. PO’s expert (who does not
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`qualify as the POSITA3) merely testified that a “prudent” pharmacist “calculating
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`the potential aluminum exposure . . . would use the 5,000 [ppb] aluminum
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`concentration to do so.” Ex. 2001, ¶¶ 21-23. But the assumption a clinician might
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`make about potential aluminum exposure for purposes of treating a patient does not
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`3 The Decision adopted Petitioner’s definition of the POSITA. Paper No. 11 at 9-
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`10. PO’s technical expert does not meet that definition.
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`9
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`
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`address, let alone rebut, Dr. Rabinow’s testimony that the POSITA would have
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`understood from the Sandoz Label that the aluminum content is somewhere within
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`the range extending between zero (or, according to the Board, some amount above
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`zero) and 5,000 ppb during the product’s shelf-life.
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`III. CONCLUSION
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`
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`For each of these reasons independently, Petitioner respectfully requests
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`rehearing and institution of trial.
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`May 5, 2020
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`
`
`
`
` /s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No 34,167)
`
`HAYNES and BOONE LLP
`2323 Victory Ave. Suite 700
`Dallas, TX 75219
`Tel.: (312) 216-1620
`ralph.gabric.ipr@haynesboone.com
`
`Counsel for Petitioner
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`
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`10
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`
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. §§ 42.105 and 42.6, I certify I caused a true and correct
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`copy of the forgoing document on Patent Owner as detailed below.
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`
`
`Date of service May 5, 2020
`
`Person served Dorothy P. Whelan
`PGR48751-0005PS1@fr.com
`
`Alana Mannige
`PTABInbound@fr.com
`
`
`
`
`
`/s/ Ralph J. Gabric
`Ralph J. Gabric (Reg. No 34,167)
`
`HAYNES AND BOONE LLP
`2323 Victory Ave. Suite 700
`Dallas, TX 75219
`Tel.: (312) 216-1620
`ralph.gabric.ipr@haynesboone.com
`Counsel for Petitioner
`
`
`
`
`
`
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