Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 43
`Entered: June 22, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`
`
`Case PGR2017-00008
`Patent 9,283,239 B2
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`Post-grant Review
`35 U.S.C. § 328(a) and C.F.R. § 42.73
`
`
`
`
`
`Tel: 571-272-7822
`
`
`Paper 43
`Entered: June 22, 2018
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`GRÜNENTHAL GMBH,
`Petitioner,
`
`v.
`
`ANTECIP BIOVENTURES II LLC,
`Patent Owner.
`
`
`Case PGR2017-00008
`Patent 9,283,239 B2
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`SHERIDAN K. SNEDDEN, Administrative Patent Judges.
`
`SNEDDEN, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`Post-grant Review
`35 U.S.C. § 328(a) and C.F.R. § 42.73
`
`
`
`
`
`
`Case PGR2017-00008
`Patent 9,283,239 B2
`
`I.
`
`INTRODUCTION
`This is a Final Written Decision in a post-grant review challenging the
`patentability of claims 1–17 of U.S. Patent No. 9, 283,239 B2 (Ex. 1003;
`“the ’239 patent”).
`We have jurisdiction under 35 U.S.C. § 6. This Decision is issued
`pursuant to 35 U.S.C. § 328(a). We conclude for the reasons that follow that
`Petitioner has shown by a preponderance of the evidence that claims 1–17
`are unpatentable for a lack of written description.
`
`A. Procedural History
`Grünenthal GmbH (“Petitioner”) filed a Petition (Paper 2; “Pet.”)
`requesting post-grant review of claims 1–17 of the ’239 patent. Antecip
`Bioventures II LLC (“Patent Owner”) filed a Patent Owner Preliminary
`Response. Paper 6 (“Prelim. Resp.”). Based on these submissions, we
`instituted trial on the following grounds of unpatentability asserted by
`Petitioner:
`
`Statutory Basis Challenged Claims
`Ground
`§ 112(a)
`1–17
`Written Description
`Decision to Institute (Paper 7, “Dec.”).
`After institution of trial, Patent Owner filed a Patent Owner Response
`(Paper 19, “PO Resp.”), to which Petitioner filed a corrected Reply to Patent
`Owner Response (Paper 28, “Reply”).
`Oral argument was conducted on April 5, 2018. A transcript is entered
`as Paper 39 (“Tr.”).
`After the oral argument in this IPR occurred, the Supreme Court held
`that a decision to institute under 35 U.S.C. § 314 may not institute on less
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`than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct.
`1348 (2018). In view of SAS, we modified our institution decision to
`institute on all of the challenged claims and all of the grounds presented in
`the petition. Paper 40. Subsequently, the parties filed a Joint Motion to
`Limit the Petition, requesting that we limit the issues to be considered in this
`proceeding to Petitioner’s challenge of claims 1–17 based on written
`description under 35 U.S.C. § 112. Paper 41. We granted the parties’ Joint
`Motion to Limit the Petition. Paper 42. As such, the sole ground of
`unpatentability remaining in dispute and considered in the Final Written
`Decision is the challenge to claims 1–17 the ’239 patent based on written
`description under 35 U.S.C. § 112.
`Petitioner relies on the Declaration of Dr. Stephen Bruehl, Ph.D.
`(Ex. 1001) in support of the Petition. Petitioner relies on the Declaration of
`Dr. David Brayden, Ph.D. (Ex. 1053) to support its Reply.
`Patent Owner relies on the Declarations of Dr. Socrates Papapoulos,
`M.D., Ph.D. (Ex. 2001 and Ex. 2015) and the Declaration of Dr. Christopher
`Gharibo, M.D. (Ex. 2002) in support of the Patent Owner Response.
`
`B. The ’239 Patent
`The ’239 patent is directed to “oral dosage forms of bisphosphonate
`compounds, such as zoledronic acid, that can be used to treat or alleviate
`pain or related conditions.” Ex. 1003, 1:35–37. One such condition,
`Complex Regional Pain Syndrome (“CRPS”), is “a debilitating pain
`syndrome . . . characterized by severe pain in a limb accompanied by edema,
`and autonomic, motor and sensory changes.” Id. at 4:57–59.
`Bisphosphonates generally have low oral bioavailability, and the ’239 patent
`describes enhancing oral bioavailability of zoledronic acid by administering
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`it in the disodium salt form. Id. at 1:30–31, 38–41. An oral dosage form of
`zoledronic acid may be used to treat CRPS. Id. at 2:12–15.
`According to the specification,
`In some embodiments, the monthly dose of zoledronic acid . . .
`is about 5000 mg or less, about 4000 mg or less, about 3000 mg
`or less, about 2000 mg or less, about 1000 mg or less, about 700
`mg or less, about 600 mg or less, about 1 mg to about 4,000 mg,
`about 1 mg to about 1,000 mg, about 10 mg to about 1000 mg,
`about 50 mg to about 1000 mg, about 10 mg to about 600 mg,
`about 40 mg to about 600 mg, about 50 mg to about 600 mg, or
`about 100 mg to about 600 mg, about 40 mg to about 2000 mg,
`about 40 mg to about 800 mg, about 50 mg to about 800 mg, or
`about 100 mg to about 800 mg, about 40 mg to about 1000 mg,
`about 50 mg to about 1000 mg, or about 100 mg to about 1000
`mg, or any monthly dose in a range bounded by, or between, any
`of these values.
`Id. at 11:34–48.
`The monthly dose may be administered for only 1 month, or may
`be repeatedly administered for 2 or more months.
`Id. at 12:2–3.
`Column 10 of the specification provides the following guidance with
`regard to dosing regimens:
`
`Any suitable amount of zoledronic acid may be used.
`Some solid or liquid oral dosage forms, or units of oral dosage
`forms (referred to collectively herein as “oral dosage form(s)”)
`may contain about 0.005 mg to about 20 mg, about 0.1 mg to
`about 10 mg, about 0.5 mg to about 10 mg, about 0.2 mg to about
`5 mg, about 1 mg to about 500 mg, about 1 mg to about 50 mg,
`about 10 mg to about 250 mg, about 100 mg to about 300 mg,
`about 20 mg to about 200 mg, about 20 mg to about 150 mg,
`about 30 mg to about 100 mg, about 1 mg to about 1,000 mg,
`about 10 mg to about 50 mg, about 10 mg to about 300 mg, about
`10 mg to about 150 mg, about 10 mg to about 100 mg, about 40
`mg to about 150 mg, about 10 mg to about 600 mg, about 40 mg
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`to about 600 mg, about 40 mg to about 2000 mg, about 40 mg to
`about 800 mg, about 25 mg to about 800 mg, about 30 mg to
`about 800 mg, about 10 mg to about 500 mg, about 50 mg to
`about 150 mg, about 50 mg, about 100 mg, about 50 mg to about
`500 mg, about 100 mg to about 2000 mg, about 300 mg to about
`1500 mg, about 200 mg to about 1000 mg, about 100 mg to about
`500 mg, or about 150 mg of zoledronic acid, or any amount of
`zoledronic in a range bounded by, or between, any of these
`values. In some embodiments, the oral zoledronic acid is
`administered daily, weekly, monthly, every two or three months,
`once a year, or twice a year.
`Id. at 10:40–63 (emphasis added).
`Column 13 of the specification provides the following guidance with
`regard to dosing regimens:
`
`In some embodiments, an oral dosage form comprises
`about 10 mg to about 150 mg or about 10 mg to about 100 mg of
`zoledronic acid, and is administered daily for about 5 to about
`10 consecutive days. This regimen may be repeated once
`monthly, once every two months, once every three months, once
`every four months, once every five months, once every six
`months, once yearly, or once every two years.
`Ex. 1003, 13:34–40 (emphasis added).
`Example 3 of the ’239 patent reports on treatment of CRPS with
`orally administered zoledronic acid in a rat tibia fracture model. Id. at
`17:18–25. CRPS was induced by fracturing the right distal tibias of the
`animals, then casting the fractured hindpaws for four weeks. Id. at
`17:25–28. The animals were orally administered either a vehicle (control) or
`18 mg/m2/day of zoledronic acid for 28 days. Id. at 17:32–34. After 28
`days, the casts were removed and the animals tested for hindpaw pain,
`edema, and warmth. Id. at 17:37–39. Figures 3–6 of the ’239 patent depict
`the results of the treatment. The ’239 patent states that “a daily dose of 18
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`mg/m2 corresponds to a monthly dose of about 500–560 mg/m2 or a human
`dose of about 800–900 mg.” Id. at 18:50–54.
`
`C. Illustrative Claim
`Claim 1, the only independent claim, is illustrative and reproduced
`
`below.
`1. A method of treating complex regional pain syndrome
`comprising orally administering zoledronic acid to a human
`being in need thereof, wherein the human being receives about
`80 to about 500 mg of zoledronic acid within a period of six
`months.
`II. DISCUSSION
`A. Claim Construction
`In a post-grant review, the claims of an unexpired patent are
`interpreted using the broadest reasonable construction in light of the
`specification of the patent in which they appear. 37 C.F.R. § 42.200(b);
`Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144–46 (2016). Under
`that standard, claim terms are given their ordinary and customary meaning,
`as would be understood by one of ordinary skill in the art in the context of
`the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249, 1257
`(Fed. Cir. 2007). Any special definition for a claim term must be set forth in
`the specification with reasonable clarity, deliberateness, and precision. In re
`Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`We determine that the claims do not require explicit construction of
`any claim term for the purposes of this Final Written Decision. See, e.g.,
`Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011)
`(“[C]laim terms need only be construed ‘to the extent necessary to resolve
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`the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200
`F.3d 795, 803 (Fed. Cir. 1999)).
`
`B.
`
`Asserted Unpatentability under the Written Description Provision of
`35 U.S.C. § 112(a)
`Petitioner contends that claims 1–17 are unpatentable for insufficient
`written description of the dosing regimen limitation “about 80 to about 500
`mg of zoledronic acid within a period of six months,” as recited in
`independent claim 1. Pet. 19–24. Petitioner separately challenges claim 17
`for lacking written description of an oral dosage form containing “at least
`10% zoledronic acid.” Id. at 25. Patent Owner opposes Petitioner’s
`arguments regarding written description of the dosing regimen limitation
`“about 80 to about 500 mg of zoledronic acid within a period of six months.”
`PO Resp. 13–37. Patent Owner, however, does not specifically address
`Petitioner’s arguments with regard to the limitation “at least 10% zoledronic
`acid.”
`We address the parties’ arguments below.
`1. Law of Written Description
`The written description requirement is satisfied when the specification
`“set[s] forth enough detail to allow a person of ordinary skill in the art to
`understand what is claimed and to recognize that the inventor invented what
`is claimed.” University of Rochester v. G.D. Searle & Co., Inc., 358 F.3d
`916, 928 (Fed. Cir. 2004). The specification does not have to provide exact
`or verbatim textual support for the claimed subject matter at issue. Fujikawa
`v. Wattanasin, 93 F.3d 1559, 1570 (Fed.Cir.1996). The Federal Circuit has
`also clarified that
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`Although [the applicant] does not have to describe exactly the
`subject matter claimed, . . . the description must clearly allow
`persons of ordinary skill in the art to recognize that [he or she]
`invented what is claimed . . . . The test for sufficiency of support
`. . . is whether the disclosure of the application relied upon
`“reasonably conveys to the artisan that the inventor had
`possession at that time of the later claimed subject matter.”
`Vas–Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (citations
`omitted). Moreover, the Federal Circuit has “made clear that the written
`description requirement does not demand either examples or an actual
`reduction to practice.” Capon v. Eshhar, 418 F.3d 1349, 1352 (Fed. Cir.
`2005). “An applicant is not required to describe in the specification every
`conceivable and possible future embodiment of his invention.” Cordis
`Corp. v. Medtronic AVE, Inc., 339 F.3d 1352, 1365 (Fed. Cir. 2003).
`Furthermore, “[a] specification may . . . contain a written description of a
`broadly claimed invention without describing all species that [the] claim
`encompasses.” Id.
`Finally, the written description inquiry is a question of fact, is context-
`specific, and must be determined on a case-by-case basis. Ariad Pharms.,
`Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (citing
`Ralston Purina Co. v. Far–Mar–Co, Inc., 772 F.2d 1570, 1575; Capon v.
`Eshhar, 418 F.3d at 1357–58); See Vas–Cath, 935 F.2d at 1561–62
`(Precisely how close the original description must come to comply with the
`description requirement of § 112 must be determined on a case-by-case
`basis.).
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`2. Claim 1: “about 80 to about 500 mg of zoledronic acid within a
`period of six months”
`a. Petitioner’s Contentions
`Petitioner contends that “all of the claims contain a dosing regimen
`limitation requiring that ‘the human being receives about 80 to about 500 mg
`of zoledronic acid within six months.’” Pet. 19–20. Petitioner contends,
`however, that “[t]he dosing regimen limitation recited in claim 1 does not
`appear anywhere in the ’239 patent specification.” Id. at 21. Rather, the
`recited dosing regimen limitation was first added by amendment to
`application claim 1 on October 28, 2015, and later amended by Examiner’s
`Amendment to its final form. Id. (citing Ex. 1009, 363, 426). Petitioner
`contends that “[a]ll of the ’239 patent claims are invalid for lack of written
`description because the ’239 patent specification fails to demonstrate that the
`inventors were in possession of the dosing regimen limitation.” Id. at 20.
`In support of its position, Petitioner contends that the ’239 patent
`specification “lists dozens of dosage amounts, frequencies and durations of
`treatment, and conditions to be treated” (Reply 1), which allows Patent
`Owner “to piece together the claimed dosing regimen by cherry-picking
`particular amounts, frequencies, and durations of administration from the
`many options listed” (Reply 4). See also Pet. 21 (“The specification does
`not mention the claimed range, but instead lists dozens of broad dosage
`ranges.”). According to Petitioner, the disclosed broad ranges “allow[] for
`administration of from 0.005 mg to 730,000 mg of zoledronic acid within
`one year (i.e., 0.005 mg once a year to 2,000 mg daily) to treat virtually any
`pain indication.” Reply 1 (citing Ex. 1003, 10:40–63); Pet. 21–22. That is,
`“the specification describes the administration of virtually any amount of
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`zoledronic acid over virtually any period of time.” Pet. 23 (citing Ex. 1001
`¶¶ 74–81).
`Petitioner acknowledges that the disclosed ranges are broader than the
`claimed range, but argues that “this is not enough to satisfy the written
`description requirement.” Pet. 22. Rather, Petitioner contends that
`
`Even if a claimed range is narrower than the ranges that can be
`gleaned
`from
`the specification,
`the written description
`requirement is not satisfied where, as here, the specification does
`not clearly disclose to a [person of ordinary skill in the art] that
`the inventors considered the claimed range to be part of their
`invention.
`Id. at 22 (citing Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1327
`(Fed. Cir. 2000)); see also Reply 7 (“Given the complete lack of guidance in
`the specification, ‘one is left to selection from the myriads of possibilities
`encompassed by the broad disclosure, with no guide indicating or directing
`that this particular selection should be made rather than any of the many
`others which could also be made,’” quoting In re Ruschig, 379 F.2d 990, 995
`(C.C.P.A. 1967)).
`With reference to the disclosure on column 10 of the ’239 patent,
`Petitioner further contends that
`
`In addition to the many broad ranges listed, the specification
`states that “any monthly dose in a range bounded by, or between,
`any of these values” may be employed. Exh. 1003, col. 11, ll.
`46–47, 59–61. It further instructs that the “effective amount of
`zoledronic acid or another bisphosphonate will vary depending
`on various factors known to the treating physicians.” Id. at col.
`10, ll. 10-16; Exh. 1001, ¶ 75. Essentially, the specification
`describes the administration of virtually any amount of
`zoledronic acid over virtually any period of time. Exh. 1001,
`¶¶ 74–81.
`Id. at 23.
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`With reference to the disclosure on column 13 of the ’239 patent,
`
`Petitioner contends that
`
`column 13 states that from about 10 mg to about 300 mg of
`zoledronic acid may be administered for about 2 to about 15
`consecutive days, repeated anywhere from monthly to every two
`years. [Ex. 1003,] col. 13, ll. 20–47. Essentially, the
`specification posits that any amount of zoledronic acid may be
`administered at any frequency over any time period. See Petition
`at 21–23; Exh. 1001 ¶¶ 74–81.
`Reply 4.
`Regarding Examples 3 and 7 of the ’239 patent, Petitioner contends
`that the dog bioavailability study of Example 7 and the rat efficacy study of
`Example 3 do not support the human dosing regimen recited in the claims.
`Pet. 23 (noting that the ’239 patent discloses that the dose used in Example 3
`“is equivalent to a monthly human dose of about 800–900 mg” (citing Ex.
`1003, 17:32–39, 18:50–55)); Reply 11–22.
`Focusing on the claim language “within a period of six months,”
`Petitioner contends as follows:
`
`the specification does not indicate to a [person of ordinary skill
`in the art] that the amount of zoledronic acid administered over
`the course of a period of six months, in particular, is important.
`For example, the specification discloses dosage ranges and
`embodiments that specify the amount of zoledronic acid
`administered in about 1 month, about 3 months, about 6 months,
`about 1 year, or one month or less. See, e.g., Exh. 1003, col.
`25-26, embodiments 46, 47, 48, 49, 51, 62. To the extent the
`specification does describe periods of six months, it does not
`specify the administration of the amounts recited in claim 1 over
`six months.
`Id. at 24.
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`b. Patent Owner’s Contentions
`Patent Owner contends that the ’239 patent specification provides
`explicit support for the dosage range of about 80 to about 500 mg of
`zoledronic acid within a period of six months, and does so “in multiple
`ways.” PO Resp. 13–37. First, Patent Owner directs our attention to the
`following disclosure found on column 10 of the ’239 patent specification
`where the following ranges are expressly disclosed: (i) about 10 mg to about
`250 mg, (ii) about 40 mg to about 150 mg, (iii) about 50 mg to about 500
`mg, and (iv) about 100 mg to about 500 mg. PO Resp. 13–14 (citing Ex.
`1001 10:40–63). In the same paragraph, the ’239 patent specification
`discloses that “[i]n some embodiments, the oral zoledronic acid is
`administered daily, weekly, monthly, every two or three months, once a
`year, or twice a year.” Id. (emphasis added). Patent Owner characterizes
`column 10 of the ’239 patent as providing “a dosing regimen of ‘about 100
`mg to about 500 mg[’] . . . . administered . . . twice a year, thus disclosing,
`the upper limit ‘about 500 mg’ dosage over 6 months verbatim, and also the
`lower limit ‘about 80 mg’ over 6 months dosage, rounded up to 100 mg.”
`Id.
`
`Moreover, Patent Owner’s expert, Dr. Papapoulos, testifies that
`disclosure of the range “about 20 mg to about 150 mg” found on column 10
`the ’239 patent further provides express support for the claimed dosing
`range. Specifically, Dr. Papapoulos testifies as follows:
`
`With respect to the ranges in the claims and the
`specification of the ‘239 patent, a person of ordinary skill in the
`art would have recognized that the ends of these ranges are
`estimates, which would preferably be described by a single
`significant figure. In fact, a single significant figure may be too
`precise for many estimates and use of the term “about” help to
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`further convey that the value is an estimate. For example, the
`nominal values of about 80 mg to about 500 mg administered
`every 2 months for six months are 26.7 mg and 166 mg,
`respectively but to avoid conveying an exaggerated level of
`precision would be expressed in round number as, for example,
`at col. 10, lines 47 and 60-62 as “about 20 mg to about 150 mg .
`. . . administered . . . . every two . . . months. (Ex. 1003, ’239
`Patent.) Similarly, a six month dose of about 80 to about 500 mg
`is expressed in round numbers at col. 10, lines 47 and 58-62 as
`“about 100 mg to about 500 mg . . . administered . . . twice a
`year.” (Ex. 1003, ’239 Patent.)
`Ex. 2015 ¶ 26; see also PO Resp 14.
`
`Next, Patent Owner directs our attention to the following disclosure
`found on column 13 of the ’239 patent specification for support of the
`claimed dosage range:
`
`In some embodiments, an oral dosage form comprises
`about 10 mg to about 150 mg or about 10 mg to about 100 mg of
`zoledronic acid, and is administered daily for about 5 to about
`10 consecutive days. This regimen may be repeated once
`monthly, once every two months, once every three months, once
`every four months, once every five months, once every six
`months, once yearly, or once every two years.
`Ex. 1003, 13:34–40 (emphasis added; see Ex. 2015 ¶ 28); see also, Ex. 2015
`¶ 29 (“the paragraphs of the specification immediately before and after the
`paragraph referred to above likewise encompass an eight-consecutive-day,
`10 mg per day dosing regimen, administered once every six months, and
`thus likewise support my conclusion that the inventor was in possession of a
`six-month dosing regimen having an 80 mg low end”). Patent Owner
`contends that this paragraph on column 13 “disclose[s] a dosing regimen of
`about 10 mg per day and a dosing period of eight consecutive days (totaling
`80 mg) with a repetition of the cycle for the dosing period of ‘once every six
`months,’ thus disclosing a dosage of 80 mg within a six-month period, the
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`lower limit of the range.” PO Resp. 14; Tr. 24:8–25:7,
`30:16–33:11, 45:3–46:22.
`Regarding the upper limit of about 500 mg, Patent Owner contends as
`follows:
`
`this same dosing regimen of 10 mg per day for eight consecutive
`days can be “repeated once monthly.” (Ex. 1003, ’239 patent, at
`col. 13, lines 37–38.) If this is done for six months, a dose of
`about 480 mg is administered within a period of six months,
`which is the same as about 500 mg.
`PO Resp. 14 (citing Ex. 2015 ¶¶ 18, 26–29); Tr. 24:8–25:7, 30:16–33:11,
`45:3–46:22.
`Next, Patent Owner contends a person of ordinary skill in the art
`would understand
`
`that the inventor was in possession of a range of about 40 mg to
`about 250 mg of zoledronic acid administered every three
`months, . . . which equates to about 80 to about 500 mg over six
`months, from the single paragraph in the specification stating
`“about 40 mg to about 150 mg” and “. . . about 10 mg to about
`250 mg . . .” and “or any amount of zoledronic in a range
`bounded by, or between, any of these values . . . administered . .
`. every . . . three months . . . .
`PO Resp. 16 (citing Ex. 1003, ’239 patent col. 10, lines 46–62 (emphasis
`added); Ex. 2015 ¶ 20 (“A person with ordinary skill in the art would have
`known that, due to their specific pharmacological properties,
`bisphosphonates can be given at different time intervals without losing their
`efficacy and that the total dose rather than the dosing interval will determine
`the final response.”); see also id. at ¶ 24 (“in phase 2 clinical study
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`intravenous infusions of zoledronic acid 1 mg every 3 months, 2 mg every 6
`months, or 4 mg once yearly induced the same pharmacodynamic
`response”).
`Next, Patent Owner contends that “a person of ordinary skill in the art
`would have recognized that the ends of these ranges are estimates, which
`would preferably be described by a single significant figure,” and provides
`numerous examples in which the end points of the ranges are approximated
`by the ranges expressly disclosed by the ’239 patent, emphasizing the
`“about” language of the claims. PO Resp. 17–22.
`Patent Owner further contends that Examples 3 and 7 of the ’239
`patent also provides explicit support in the specification for the use of the
`overall dosage range about 80 mg to about 500 mg to treat CRPS. PO Resp.
`23–26.
`
`c. Analysis
`We first consider whether the specification provides written
`description support for the range of “about 80 to about 500 mg of zoledronic
`acid” recited by the claims. As noted by the Patent Owner, column 10 of the
`’239 patent specification discloses ranges that would encompass the claimed
`range. PO Resp. 13–14. In particular, the specification discloses the range
`of “about 50 mg to about 500 mg,” thereby giving literal support to this
`range and to the endpoint of “about 500 mg.” Ex. 1003, 10:56. While the
`endpoint of “about 80 mg” is not expressly disclosed in combination with
`the 500 mg endpoint, we note that the Federal Circuit explained that
`
`If lack of literal support alone were enough to support a rejection
`under § 112, then the statement of In re Lukach . . . that “the
`invention claimed does not have to be described in ipsis verbis in
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`Patent 9,283,239 B2
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`order to satisfy the description requirement of § 112,” is empty
`verbiage.
`Union Oil Co. of California v. Atl. Richfield Co., 208 F.3d 989, 1000 (Fed.
`Cir. 2000) (“Unocal”), quoting In re Wertheim, 541 F.2d 257, 265 (C.C.P.A.
`1976). We thus consider whether the description “clearly allow persons of
`ordinary skill in the art to recognize” the claimed invention. Vas–Cath, 935
`F.2d at 1563.
`We find that the facts of this case differ significantly from the facts in
`Unocal or Wertheim where the specification clearly allowed persons of
`ordinary skill in the art to recognize the claimed invention despite the
`absence of literal support. In Unocal, the original disclosure explicitly
`described the effects of altering the variables, explicitly described the
`claimed endpoints as preferred, or explicitly recited them in an original
`claim. Moreover, persuasive expert testimony was offered to support the
`finding that the specification reasonably conveyed to one skilled in the
`relevant art that the inventor possessed the later claimed invention. Unocal,
`208 F.3d at 993, 998–99. In Wertheim, the CCPA held that the specification
`supported the claimed range of 35–60% where the specification described
`the range of 25–60% along with specific embodiments of 36% and 50%.
`541 F.2d at 264–65.
`In this case, the ’239 patent specification does not clearly allow
`persons of ordinary skill in the art to recognize the “about 80 mg” endpoint
`as part of invention described in the ’239 patent. There is no disclosure of
`“about 80 mg” as a preferred endpoint, no disclosure of a specific
`embodiment including a dose of 80 mg, nor any other description suggesting
`the importance or criticality of the “about 80 mg” endpoint.
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`In view of the lack of any explicit disclosure for “about 80 mg”
`endpoint, Patent Owner suggests that the “about 80 mg” endpoint may be
`derived from the specification in numerous ways. PO Resp. 13–33;
`Ex. 2015 ¶¶ 26, 28. For example, Patent Owner argues that the endpoint of
`80 mg finds support in column 13 of the specification, which discloses a
`range of “about 10 mg to about 100 mg” administered over the course of 5 to
`10 consecutive days, thereby essentially disclosing a list six different ranges
`that includes the ranges of about 50 mg to about 500 mg and about 80 mg to
`about 800 mg. PO Resp. 14 (citing Ex. 2015 ¶¶ 18, 26–29); Tr. 24:8–25:7,
`30:16–33:11, 45:3–46:22.
`We are aware of cases indicating that the written description analysis
`requires consideration as to whether one of skill in the art could derive the
`claimed ranges from the specification. See e.g., Purdue Pharma L.P. v.
`Faulding Inc., 230 F.3d at 1327; Vas–Cath Inc. v. Mahurkar, 935 F.2d at
`1563–64; Ralston Purina Co. v. Far–Mar–Co, Inc., 772 F.2d at 1575 ; In re
`Wertheim, 541 F.2d at 264–65. For example, we note that “ranges found in
`applicant’s claims need not correspond exactly to those disclosed in [the
`specification, so long as] one skilled in the art could derive the claimed
`ranges from the [ ] disclosure.” Vas–Cath, 935 F.2d at 1566. However,
`none of the cases concluding that sufficient written description existed such
`that a person of ordinary skill in the art could derive a claimed range from a
`specification are factually equivalent to the present case, where, as here, a
`non-original claim recites a dosage regimen range with endpoints derived
`from an inordinate amount of picking and choosing from disparate
`disclosures of various embodiments reciting broader ranges. For example,
`in Ralston, the Federal Circuit held that the disclosure of 25%–27% water in
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`a soybean mixture did not support broader claims to “at least 20%,”
`“between 20% and 40%,” or “in the range of 20%–30%” moisture levels,
`but did support moisture levels of “at least about 25% by weight” and “at
`least 25% by weight,” reasoning that the open-ended claims would be
`limited by what a person skilled in the art would understand to be workable.
`772 F.2d at 1576; see also, In re Wertheim, 541 F.2d at 264–65 (discussed
`hereinabove).
`By comparison, we find the factual situation in this case to be closest
`to the situation in Purdue Pharm, where the Federal Circuit held that claims
`reciting an extended-release drug formulation requiring a certain ratio
`between the drug’s maximum blood concentration (Cmax) and its
`concentration at twenty-four hours after administration (C24) could not be
`derived from the specification. 230 F.3d at 1323. The patentee argued the
`written description provided adequate support under § 112 because of two
`examples in the specification in which the Cmax/C24 ratio was greater than
`two. Id. at 1326. The court, however, upheld the district court’s finding that
`the written description was insufficient:
`
`Although the examples provide the data from which one can
`piece
`together
`the Cmax/C24
`limitation, neither
`the
`text
`accompanying the examples, nor the data, nor anything else in
`the specification in any way emphasizes the Cmax/C24 ratio. The
`district court therefore reasonably concluded that one of ordinary
`skill in the art would not be directed to the Cmax/C24 ratio as an
`aspect of the invention. . . . [T]he disclosure of the ’360 patent
`discloses a multitude of pharmacokinetic parameters, with no
`blaze marks directing the skilled artisan to the Cmax/C24 ratio or
`what value that ratio should exceed.
`Id. The court held that the written description requirement was not met,
`stating that “[b]ecause the specification does not clearly disclose to the
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`skilled artisan that the inventors . . . considered the Cmax/C24 ratio to be part
`of their invention, it is immaterial what range for the Cmax/C24 ratio can be
`gleaned from the examples when read in light of the claims.” Id. at 1328.
`Likewise, here, there is no description in the ’239 patent specification that
`attaches any significance to orally dosing a patient using about 80 mg of
`zoledronic acid, and as such the “about 80 mg” endpoint is not derivable
`from the ’239 patent specification.
`Furthermore, we note that the disparate disclosures of the ’239 patent
`specification upon which Patent Owner relies may very well render the
`“about 80 mg” endpoint of the claimed ranges obvious to a person having
`ordinary skill in the art. Obviousness, however, is an inappropriate standard
`to measure a claim’s compliance with the description requirement.
`Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997)
`(“One shows that one is “in possession” of the invention by describing the
`invention, with all its claimed limitations, not that which makes it obvious.”)
`Moreover, we note that the claims do not merely require
`administration of a dose of about 80 mg to about 500 mg of zoledronic acid,
`they also require that dose to b
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