Trials@uspto.gov Paper No. 13
`571-272-7822
`
` Date: July 21, 2021
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ETON PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`Patent Owner.
`____________
`
`PGR2020-00086
`Patent 10,653,719 B1
`____________
`
`
`
`Before ULRIKE W. JENKS, SUSAN L.C. MITCHELL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Petitioner’s Request on Rehearing of Decision Denying Institution
`of Post Grant Review
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`571-272-7822
`
` Date: July 21, 2021
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ETON PHARMACEUTICALS, INC.,
`Petitioner,
`v.
`
`EXELA PHARMA SCIENCES, LLC,
`Patent Owner.
`____________
`
`PGR2020-00086
`Patent 10,653,719 B1
`____________
`
`
`
`Before ULRIKE W. JENKS, SUSAN L.C. MITCHELL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`
`JENKS, Administrative Patent Judge.
`
`
`
`
`DECISION
`Denying Petitioner’s Request on Rehearing of Decision Denying Institution
`of Post Grant Review
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`PGR2020-00086
`Patent 10,653,719 B1
`
`I. INTRODUCTION
`Eton Pharmaceuticals Inc. (“Petitioner”) requests rehearing of our
`Institution Decision (“Decision”) denying post-grant review of claims 1–27
`of U.S. Patent No. 10,653,719 B1 (Ex. 1106, “the ’719 patent”) entered on
`April 23, 2021 (Paper 11, “Dec.”). Paper 12 (“Req. Reh’g”).
`We denied institution based on our determination that Petitioner’s
`contentions relying on reasonable expectation of success based on
`overlapping ranges was not sufficiently supported by the evidence in the
`record. Dec. 15–26. We also determined that the Petition fails to meet the
`particularity requirement of 35 U.S.C. § 322(a)(3) with regard to Petitioner’s
`assertion that the subject matter of the claims would have been obvious over
`the Sandoz Label in conjunction with the knowledge of a person of ordinary
`skill in the art. Dec. 17.
`In its Request for Rehearing, Petitioner contends that the Board in the
`Decision misapprehends Petitioner’s assertions based on reasonable
`expectation of success argument that does not rely on overlapping ranges to
`establish unpatentability, that the Sandoz Label encompasses the claimed
`aluminum range, and that the Board abused its discretion in finding lack of
`particularity. See generally Req. Reh’g.
`Having reconsidered Petitioner’s arguments in view of the Request for
`Rehearing we modify the Decision to incorporate and address Petitioner’s
`contentions with respect to their reasonable expectation of success
`assertions. For the reasons discussed below, the modification of our
`Decision does not alter the outcome. As a result, we deny Petitioner’s
`Request for Rehearing.
`
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`PGR2020-00086
`Patent 10,653,719 B1
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`STANDARD OF REVIEW
`II.
`A party requesting rehearing has the burden to show a decision should
`be modified by specifically identifying all matters the party believes were
`misapprehended or overlooked, and the place where each matter was
`addressed previously in a motion, opposition, or a reply. 37 C.F.R.
`§ 42.71(d). When rehearing a decision on institution, we review the decision
`for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may
`arise if a decision is based on an erroneous interpretation of law, if a factual
`finding is not supported by substantial evidence, or if the decision represents
`an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v.
`United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v.
`Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d
`1305, 1315–16 (Fed. Cir. 2000).
`III. ANALYSIS
`In its Request for Rehearing, Petitioner contends that the Board in the
`Decision misapprehends Petitioner’s reasonable expectation of success
`assertions, determination that the Sandoz Label discloses a range, and
`abused its discretion in finding lack of particularity in the Petition. See
`generally Req. Reh’g.
`1.) Reasonable Expectation of Success
`Petitioner argues that in the Petition they presented a separate
`reasonable expectation of success argument and therefore it is not a new
`argument but instead is based on the ability of a person of ordinary skill in
`the art to reach “the claimed aluminum levels by simply removing the
`known sources of aluminum contamination from the Sandoz Label product.”
`Req. Reh’g 2; Pet. 33, 42–43. Petitioner contends that the Decision
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`Patent 10,653,719 B1
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`overlooks that a person of ordinary skill in the art would have eliminated
`“known sources of aluminum” (Req. Reh’g 2), for example, from the
`component ingredients as well as glass containers. Req. Reh’g 3 (citing Pet.
`32–33, section VIII.E).
`Even if we were to agree with Petitioner that the Petition included a
`separate “reasonable expectation of success argument” that did not rely on
`overlapping ranges, we again find that Patent Owner has the better position.
`In our Decision, we agreed with Petitioner that there was ample motivation
`for reducing aluminum levels in parenteral solutions. See Dec. 22. In the
`Decision, however, we explained that motivation alone is not sufficient for
`reaching a conclusion of obviousness because it does not, without more,
`provide a path for how to achieve the stated goal. Id.
`The issue is not whether an ordinary artisan recognized sources of
`aluminum contamination that could potentially be eliminated; the question is
`whether there is reasonable expectation that removing an aluminum source
`results in a product that contains less than about 150 ppb and “is
`substantially free of visually detectable particulate matter and suitable for
`use as an additive in a parenteral nutrition composition for administration to
`an individual” as defined by the ’719 patent. We agree with Patent Owner’s
`response that “the kinetics and equilibrium chemistry of the various L-
`cysteine and cystine species in any particular L-cysteine solution are
`complex and influenced by multiple interacting variables of that
`environment, including oxygen levels, pH, and the presence of trace metals.”
`Prelim Resp. 19–20. Patent Owner further explains that “removing
`Aluminum may have the unintended consequence of increased [cystine]
`precipitation and product failure in the presence of even small amounts of
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`PGR2020-00086
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`oxygen in the container.” Id. at 21 (citing Ex. 1106, 5:19–23 (“[R]emoving
`Aluminum may have the unintended consequence of increased precipitation
`and product failure in the presence of even small amounts of oxygen in the
`container. This was unexpected.”)); see id. at 44. In other words, the removal
`of aluminum has the unintended consequence of making the product more
`susceptible to oxygen, resulting in product precipitation, and thereby
`rendering the product unsuitable for parenteral administration. Id. at 46–47
`(“[T]he POSITA would have had to know before attempting any
`optimization that particulate matter was relevant to solving the aluminum
`problem with L-cysteine solutions.”).
`Petitioner contends that they provided unrebutted expert testimony
`supporting its position. Req. Reh’g 3–4. “The Board has broad discretion to
`assign weight to be accorded expert testimony.” Consolidated Trial Practice
`Guide1 (“CTPG”) 35 (Nov. 2019). Here, we evaluate Petitioner’s expert
`testimony against the backdrop that it took more than a decade to develop a
`cysteine containing parenteral composition that met the established FDA
`requirements. Considering the great pressure given by the FDA
`recommendation to lower aluminum content in parenteral solutions to avoid
`aluminum toxicity in vulnerable patients and the length of time it took the
`industry to produce such a product, we find that on balance this suggests that
`the solution to the problem was not straight forward as urged by Petitioner.
`See Prelim Resp. 8, 44 (citing Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d
`1346, 1354 (Fed. Cir. 2013) (“If these discoveries and advances were routine
`and relatively easy, the record would undoubtedly have shown that some
`
`
`1 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated.
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`ordinary artisan would have achieved this invention within months of [the
`prior art patents]. Instead this invention does not appear for more than a
`decade.”)); Dec. 25.
`We also agree with Patent Owner that Petitioner’s routine
`optimization argument is infected with hindsight assumptions and ignores
`the complexity of the environmental conditions that contribute to the
`aluminum levels in parenteral solutions. Prelim. Resp. 43–45; 55–63. Here,
`the person of ordinary skill in the art would have been highly motivated to
`solve the “alleged ‘problem of aluminum,’” and yet the problem had “gone
`unsolved for more than a decade” despite the supposedly “simple and
`straightforward solutions.” Id. (citing Leo Pharm. Prods., 726 F.3d at 1354).
`Given this backdrop, we agree with Patent Owner’s assertion that Petitioner
`has not articulated why a person of ordinary skill would have had a
`“reasonable expectation of success in solving the decades-old aluminum
`problem.” Id. at 44.
`In summary, in the Decision we agreed with Petitioner that there was
`ample motivation to lower aluminum concentration in parenteral
`compositions. Motivation alone, however, is not sufficient for reaching a
`conclusion of obviousness. See Dec. 21. At best, the Petition and supporting
`Rabinow Declaration identify aluminum contributing sources in the Sandoz
`Label product that one of ordinary skill in the art would have known about
`and that could have been substituted by trial and error. Considering the
`incentive given by the FDA recommendation to lower aluminum content in
`parenteral solution in order to avoid aluminum toxicity when balanced
`against the length of time it took the industry to produce such a product, we
`find that extended time between these events sufficiently suggests that the
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`solution to the problem was not as straightforward or routine as urged by
`Petitioner. See Leo Pharm. Prods., 726 F.3d at 1354.
`2.) Range
`Petitioner contends that “the Decision reviewed the Sandoz Label in a
`vacuum without reference to the knowledge possessed by the [person of
`ordinary skill in the art],” and that the disclosure is consistent with a range
`below 5,000 ppb. Req. Reh’g 7–8. Petitioner contends that Dr. Rabinow’s
`testimony is unrebutted by Patent Owner’s expert, and therefore, we should
`accept the testimony that a person of ordinary skill in the art would have
`interpreted the Sandoz Label as disclosing an aluminum concentration
`“ranging between 0 to 5,000 ppb over the product’s shelf-life” (i.e., 5,000
`ppb aluminum or less) and that the claim 1 range of less than 150 ppb
`aluminum is within the lower end of the “no more than 5,000 mcg/L” as
`recited on the label. Req. Reh’g. 8; Ex. 1003 ¶ 32.
`In the Decision, we determined that the Sandoz Label describes a
`product. Specifically, the label states that the contents contains a solution
`having “50 mg of L-cysteine hydrochloride monohydrate and water, with the
`air replaced with nitrogen, and the solution having a pH 1.0–2.5.” Dec. 7–8
`(citing Ex. 1005, 5). In the Decision, we identified that the Sandoz Label
`also recognizes that the product contains aluminum in sufficient amount that
`can be toxic, further evidencing that zero is not a reasonable endpoint. Dec.
`8 (“The Sandoz Label provides a warning that the product contains
`aluminum that may be toxic.”). The Sandoz Label lists that “the product
`contains no more than 5000 mcg/L [(5000 ppb)] of aluminum.” Dec. 8
`(footnote omitted). Based on these disclosures in the Sandoz Label we
`concluded in the Decision that the evidence in the record does not support
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`Petitioner’s position, that “the Sandoz Label should be interpreted as a
`disclosure of an aluminum range from 0 to 5000 ppb,” an interpretation
`relied on in Petitioner’s articulated ground of unpatentability. See Dec. 23
`(footnote omitted).
`The Petition cites In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir.
`2003) and ClearValue, Inc. v. Pearl River Polymers, Inc., 668 F.3d 1340,
`1345 (Fed. Cir. 2012) (disclosure of “150 ppm or less” teaches “50 ppm”) in
`support of the position that the aluminum content in the Sandoz Label and
`claim element 1(c) overlap, rendering the ’719 patent claims obvious. See
`Pet. 42–43.
`In ClearValue our reviewing court determined that a disclosure of
`150 ppm or less in the art anticipates the claimed limitation of 50 ppm or
`less. See ClearValue, 688 F.3d at 1345. Specifically, in ClearValue the court
`found that “[t]he disclosure of 150 ppm or less is a genus disclosure . . .
`[and] the example in Hassick at 60–70 ppm supports the fact that the
`disclosure of 150 ppm or less does teach one of skill in the art how to make
`and use the process at 50 ppm.” Id.
`Unlike the facts in ClearValue, the present facts do not support a
`conclusion that Sandoz Label describes produces below the level recited in
`the claim. As discussed in our Decision, the limitation “contains no more
`than 5,000 mcg/L” (i.e., 5,000 ppm) disclosed in the Sandoz Label provides
`a rather large genus, but as we explained in the Decision the lower limit is
`not zero. See Dec. 17–18 (citing Ex. 1005, 8 (“WARNING: This product
`contains aluminum that may be toxic” (emphasis omitted))). The Sandoz
`Label establishes that there is aluminum in the composition in quantities that
`may be toxic. Here, the ’719 patent explains that in order to avoid aluminum
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`toxicity in susceptible patient populations such as infants, the composition
`should comprise “no more than 250 ppb, preferably about 120 ppb, or lower,
`of Aluminum.” Ex. 1106, 7:66–67. Therefore, aluminum concentration in
`excess of 250 ppb would have been considered toxic. Because the Sandoz
`Label discloses that the product contains aluminum at levels that may be
`toxic, the label does not support aluminum levels at the lower range of the
`rather large genus.
`The Board has broad discretion in how much weight to give to expert
`testimony. CTPG 35, 40. In this case, Petitioner has not directed us to
`corroborating evidence to suggest that zero is a reasonable lower limit based
`on the disclosure in the Sandoz Label. To the contrary, Petitioner directs to
`evidence in the record (see Pet. 43 (citing Ex. 1022 ¶ 15 (citing Exhibit B
`and C))) that supports the warning in the Sandoz Label that the product
`contains aluminum, establishing that the lower limit is not reasonably zero.
`See Dec. 24 (citing Ex. 1005, 2). Accordingly, we are not persuaded by
`Petitioner’s contention that we abused our discretion to arrive at the
`conclusion that the disclosure of the Sandoz Label does not overlap the less
`than 150 ppb aluminum range recited in claim element 1(c) of the ’719
`patent.
`Petitioner and Petitioner’s expert Dr. Rabinow rely on disclosures in
`the Johnson Declaration to support a position that the Sandoz L-cysteine
`product is at the very low end of the large genus recited in the Sandoz Label.
`See Ex. 1003 ¶¶ 32–33; Pet. 28–29. We understand that extrinsic evidence
`can be used to demonstrate what is “necessarily present” in a prior art
`embodiment even if the extrinsic evidence is not itself prior art. See
`Monsanto Tech. LLC v. E.I. DuPont de Nemours & Co., 878 F.3d 1336,
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`1345 (Fed. Cir. 2018) (allowing “non-prior art data” to be used to support
`inherency). Here, Petitioner is not relying on the Johnson Declaration to
`establish that a handful of Sandoz L-cysteine products produced by Allergy
`Labs inherently meet the limitations of the claimed cysteine solution.2
`Ex. 1003 ¶ 33; Ex. 1022 ¶¶ 14–15. Instead, Petitioner is relying on the
`Johnson Declaration to establish the lower endpoint of the aluminum range
`recited in the Sandoz Label to support the position that the composition as
`claimed in the ’719 patent is obvious based on overlapping ranges. We agree
`with Patent Owner and are not persuaded that the handful of product
`examples3 provided in the Johnson Declaration fairly describe the L-cysteine
`product sold and distributed under the Sandoz Label. See Prelim. Resp. 29–
`32 (questioning whether the product tested was product that is available to
`the consumer); see also Ex. 1106, 42:35–60 (Example 2 showing
`unacceptably high aluminum content when L-cysteine is packaged in
`pharmaceutical quality glass). Accordingly, we are not persuaded that the
`Petition establishes that the Sandoz Label teaches a product having
`aluminum levels that overlaps with the claimed product.
`
`
`2 The Johnson Declaration provides a handful of “Certificate of Analysis” of
`products made by Allergy Labs for Sandoz that show aluminum levels
`below 100 ppb. See Ex. 1022 (Exhibit B and C). Petitioner, however, cites
`the Johnson Declaration not for the purpose of disclosing an anticipating
`product but instead attempts to use the information to set the lower endpoint
`of the aluminum contamination associated with the product described in the
`Sandoz Label.
`3 The Johnson Declaration does not establish how many lots of L-cysteine
`Allergy Labs produced for Sandoz over the years, thus, it is not clear
`whether the samples described in the Declaration is a fair representation of
`the Sandoz product that was sold and distributed to consumers.
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`3.) Particularity
`We are not persuaded by Petitioner’s contention that “[t]he Decision
`conflates the Sandoz Label with the Knowledge possessed by the [person of
`ordinary skill in the art].” Req. Reh’g 6, see id. at 7 (“[T]he Petition does not
`attempt (nor did it need) to back-fill the aluminum levels taught by the
`Sandoz Label with the levels found in the product that was sold in
`association with the Sandoz Label.”). We agree with Patent Owner that the
`Petition is using the references as more than just corroborating prior art. Sur-
`reply 10. Specifically, when describing the product associated with the
`Sandoz Label the Petition repeatedly references information that is not part
`of the label – but instead suggests that a person of ordinary in in the art
`could have measured certain aluminum levels in the Sandoz Product. See
`Pet. 43 (suggesting that a person of ordinary skill could have determined
`aluminum levels in the Sandoz Product and if they did so would find that the
`product contained less than 100 ppb (citing Ex. 1022 ¶ 15; Ex. 1003 ¶ 33)).
`We understand that it is permissible to rely on expert evidence that is
`corroborated by prior art to be within the general knowledge of the skilled
`artisan. Koninklijke Philips N.V. v. Google LLC, 948 F.3d 1330 (2020).
`Here, the information about specific product attributes goes beyond the
`general knowledge of the ordinary artisan. Petitioner has not cited authority
`to establish that the general knowledge of the person of ordinary skill in the
`art “includes, among other things, the attributes of the Sandoz L-cysteine
`product that was sold in association with the Sandoz Label. . . . – attributes
`which the [person of ordinary skill in the art] could have readily
`ascertained.” Req. Reh’g 6. Accordingly, we are not persuaded that we
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`abused our discretion in determining that the Petition lacked particularity
`under of 35 U.S.C. § 322(a)(3).
`IV. CONCLUSION
`We have reconsidered our decision of April 23, 2021, in light of
`
`Petitioner’s comments in the Request for Rehearing, and we modify our
`Decision in response to Petitioner’s argument by incorporating our analysis
`herein with respect to the “reasonable expectation of success” argument (see
`above III.1) that Petitioner asserts does not rely on overlapping ranges. For
`the foregoing reasons, Petitioner has not demonstrated that we abused our
`discretion in exercising our discretion to deny institution.
`V. ORDER
`In consideration of the foregoing, it is hereby ordered that the
`
`Petitioner’s Rehearing Request is denied.
`
`
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`PGR2020-00086
`Patent 10,653,719 B1
`
`PETITIONER:
`Ralph J. Gabric
`Eugene Goryunov
`Jeff Wolfson
`Judy K. He
`HAYNES AND BOONE LLP
`ralph.gabric.ipr@haynesboone.com
`eugene.goryunov.ipr@haynesboone.com
`jeff.wolfson.ipr@haynesboone.com
`judy.he.ipr@haynesboone.com
`
`PATENT OWNER:
`Dorothy P. Whelan
`Alana Mannige
`FISH & RICHARDSON P.C.
`whelan@fr.com
`mannige@fr.com
`
`
`
`
`
`13
`
`
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