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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`GRÜNENTHAL GMBH,
`
`Petitioner
`
`v.
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`ANTECIP BIOVENTURES II LLC,
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`Patent Owner
`
`Case PGR2017-00008
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`U.S. Patent No. 9,283,239
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`PATENT OWNER’S RESPONSE
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`
`
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Grun. Exh. 1043
`PGR for U.S. Patent No. 9,867,839
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`1
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`Grün. Exh. 1034
`PGR for U.S. Patent No. 10,052,338
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`

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`Post-Grant Review of U.S. Patent No. 9,283,239
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`
`
`TABLE OF CONTENTS
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`PGR2017-00008
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`Page
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`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. A PERSON SKILLED IN THE ART ............................................................. 2
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`III. PETITIONER MUST CARRY ITS BURDEN, IF AT ALL, IN ITS
`
`PETITION. ...................................................................................................... 3
`
`IV. PETITIONER HAS NOT SHOWN BY A PREPONDERANCE OF
`
`THE EVIDENCE THAT THE CLAIMS OF THE ’239 PATENT
`
`LACK WRITTEN DESCRIPTION SUPPORT. ............................................. 9
`
`A.
`
`The written description inquiry asks whether the disclosure
`conveys to those skilled in the art that the inventor had
`possession of the claimed subject matter. ........................................... 11
`
`B. Written description support exists for the dosage range about 80
`mg to about 500 mg over a six-month period. .................................... 13
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`1.
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`2.
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`3.
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`4.
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`The dosage range about 80 mg to about 500 mg within a
`six- month period is expressly disclosed at column 10,
`lines 47 and 60–62, and in combination with column 13,
`lines 27–33. ............................................................................... 13
`
`The dosage range about 80 mg to about 500 mg within a
`six month period is expressly disclosed at column 10, lines
`46-62. ........................................................................................ 16
`
`The dosage range of about 80 mg to about 500 mg over six
`months is also repeatedly disclosed in the specification by
`what appear to be nominally variant ranges, based on the
`use of the term “about”. ............................................................ 17
`
`Contrary to petitioner’s argument, Example 3 also
`provides explicit support in the specification for the use of
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`the overall dosage range about 80 mg to about 500 mg to
`treat CRPS. ................................................................................ 23
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`5.
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`The disclosure’s repeated identification of 80 mg as a
`lower limit and 500 mg as an upper limit would cause a
`POSA to recognize that the patentee was in possession of
`the claimed dosage range administered over a six month
`period......................................................................................... 27
`
`C.
`
`The claimed six-month period for a dosage range is expressly
`disclosed by the ‘239 specification, and additional emphasis is
`unnecessary because a POSA would have understood to use a
`six-month period when administering oral zoledronic acid. ............... 34
`
`V.
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`CONCLUSION .............................................................................................. 37
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`Post-Grant Review of U.S. Patent No. 9,283,239
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`TABLE OF AUTHORITIES
`
`PGR2017-00008
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` Page(s)
`
`Cases
`
`Alcon Research Ltd. v. Barr Labs., Inc.,
`745 F.3d 1180 (Fed. Cir. 2014) .......................................................................... 12
`
`Ariad Pharm., Inc. v. Eli Lilly & Co.,
`598 F.3d 1336 (Fed. Cir. 2010) (en banc) .......................................................... 12
`
`Blue Calypso, LLC v. Groupon, Inc.,
`815 F.3d 1331 (Fed. Cir. 2016) .......................................................................... 11
`
`Cohesive Techs., Inc. v. Waters Corp.,
`543 F.3d 1351 (Fed. Cir. 2008) .......................................................................... 20
`
`Crown Packaging Tech., Inc. v. Ball Metal Bev. Container Corp.,
`635 F.3d 1373 (Fed. Cir. 2011) .......................................................................... 29
`
`Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
`800 F.3d 1375 (Fed. Cir. 2015) ............................................................................ 8
`
`Ex Parte Juan Mantelle,
`Appeal No. 2015-004605, 2017 WL 2200409 (PTAB 2017) ............................ 12
`
`Ex Parte Jung-Sheng Wu and Raghunath Padiyatgh,
`110 U.S.P.Q. 561 (PTAB 2016) ......................................................................... 12
`
`In re Magnum Oil Tools Int’l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ................................................................ 5, 6, 7, 8
`
`Purdue Pharma L.P. v. Faulding Inc.,
`230 F.3d 1320 (Fed. Cir. 2000) ................................................................ 9, 10, 15
`
`Union Oil Co. of California v. A. Richfield Co.,
`208 F.3d 989 (Fed. Cir. 2000) ...................................................................... 15, 33
`
`Vas-Cath Inc. v. Mahurkar,
`935 F.2d 1555 (Fed. Cir. 1991) .......................................................................... 12
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`In re Wertheim,
`541 F.2d 257, 191 U.S.P.Q. 90 (C.C.P.A 1976) ..................................... 14, 30, 33
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`PGR2017-00008
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`Statutes
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`35 U.S.C. § 312(a)(3) ................................................................................................. 5
`
`35 U.S.C. § 316(e) ................................................................................................. 4, 7
`
`35 U.S.C. § 322(a)(3) ............................................................................................. 4, 5
`
`35 U.S.C. § 326(e) ..................................................................................................... 4
`
`Other Authorities
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`37 C.F.R. § 42.6 ....................................................................................................... 39
`
`37 C.F.R. § 42.23(b) .............................................................................................. 4, 5
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`37 C.F.R. § 42.24(d) ................................................................................................ 40
`
`37 C.F.R. § 42.220 ................................................................................................... 39
`
`U.S. Patent No. 8,802,658 ........................................................................................ 25
`
`U.S. Patent No. 9,283,239 .................................................................................passim
`
`U.S. Patent Application Publ’n No. US 2013/0404488 A1 (published
`Nov. 14, 2013) ...................................................................................................... 1
`
`U.S. Patent Application Publ’n No. US 2014/0051669 A1 (published
`Feb. 20, 2014) ....................................................................................................... 2
`
`Dave H. Schweitzer et al., Improved Treatment of Paget’s Disease
`with Dimethylaminohydroxypropylidene Bisphosphonate ................................. 35
`
`THEODORE L. BROWN ET AL., CHEMISTRY, THE CENTRAL SCIENCE
`(10th ed. 2006.) ................................................................................................... 20
`
`Ian R. Reid et al., Intravenous Zoledronic Acid In Postmenopausal
`Women With Low Bone Mineral Density............................................................ 36
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`Paul D. Miller et al., A Randomized, Double-blind Comparison of
`Risedronate and Etidronate in the Treatment of Paget’s Disease of
`Bone .................................................................................................................... 35
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`PGR2017-00008
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`T. Schnitzer et al., Therapeutic equivalence of alendronate 70 mg
`once weekly and alendronate 10 mg daily in the treatment of
`osteoporosis ........................................................................................................ 34
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`EXHIBIT LIST
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`PGR2017-00008
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`Exhibit 1003: United States Patent No. 9,283,239 (the “’239 patent”)
`
`Exhibit 1009: U.S. App. No. 14/635,857 (the “’857 Application”) File History
`
`Exhibit 1031: U.S. App. No. 14/063,979 (the “’979 Application”)
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`Exhibit 2001: Expert Declaration of Dr. Socrates Papapoulos
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`Exhibit 2002: Expert Declaration of Dr. Christopher Gharibo
`
`Exhibit 2015: Second Expert Declaration of Dr. Socrates Papapoulos
`
`Exhibit 2016: United States Patent Application Publication No. US
`
`2013/0404488 A1
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`Exhibit 2017: United States Patent Application Publication No. US
`
`2014/0051669 A1
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`Exhibit 2018: THEODORE L. BROWN ET AL., CHEMISTRY, THE CENTRAL SCIENCE
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`(10th ed. 2006)
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`Exhibit 2019: United States Patent No. 8,802,658
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`Exhibit 2020: U.S. DEP’T OF HUMAN AND HEALTH SERV., GUIDANCE FOR
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`INDUSTRY: ESTIMATING THE MAXIMUM SAFE STARTING DOSE IN
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`INITIAL CLINICAL TRIALS FOR THERAPEUTICS IN ADULT HEALTHY
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`VOLUNTEERS (July 2005)
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`Exhibit 2021: T. Schnitzer et al., Therapeutic equivalence of alendronate 70 mg
`
`once weekly and alendronate 10 mg daily in the treatment of
`
`
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`vii
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`7
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`osteoporosis, 12 AGING CLIN. EXP. RES. 1 (2000)
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`PGR2017-00008
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`Exhibit 2022: Dave H. Schweitzer et al., Improved Treatment of Paget’s Disease
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`with Dimethylaminohydroxypropylidene Bisphosphonate, 8 J.
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`BONE MINER. RES. 175–182 (1993)
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`Exhibit 2023: Paul D. Miller et al., A Randomized, Double-blind Comparison of
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`Risedronate and Etidronate in the Treatment of Paget’s Disease of
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`Bone, 106 AM. J. MED. 513 (1999)
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`Exhibit 2024: Ian R. Reid et al., Intravenous Zoledronic Acid In Postmenopausal
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`Women With Low Bone Mineral Density, 346 N. ENGL. J. MED. 9
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`(2002)
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`Exhibit 2025: Socrates E. Papapoulos, Bisphosphonates: how do they work?, 22
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`BEST PRACT. RES. CL. ENDOCRINOL. METAB. 831, 831-847 (2008)
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`Exhibit 2026: Sohail A. Khan et al., Elimination and Biochemical Responses to
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`Intravenous Alendronate in Postmenopausal Osteoporosis, 52 J.
`
`BONE MINER. RES. 1700 (1997)
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`
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`viii
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`Post-Grant Review of U.S. Patent No. 9,283,239
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`I.
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`INTRODUCTION
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`PGR2017-00008
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`The Board’s Decision instituted post-grant review on a very narrow issue:
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`whether the dosage range in claim 1 of the ’239 patent—about 80 mg to about 500
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`mg within a six-month period—is supported by the specification. As discussed
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`below, the specification provides ample express support for the claimed dosage
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`range. Not only are there multiple sources of support in the ’239 disclosure for the
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`lower and upper end of the range, about 80 mg and about 500 mg, as well as for a
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`dosing regimen over a six-month period, there are multiple sources of support for
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`the claimed dosage range itself. A person skilled in the art would have understood
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`the inventor to have been in possession of the claimed dosage range.
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`The ’239 patent covers a combination of two discoveries that converge in the
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`claims. The first discovery is the use of oral zoledronic acid to treat CRPS. That is
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`what is reflected in the first non-provisional application filed on May 14, 2013, as
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`application no. 13/894,274. (Ex. 2016, U.S. Patent Application Publ’n No. US
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`2013/0404488 A1 (hereinafter, the “’488 Application”) (published Nov. 14, 2013.)
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`The second discovery is the dosage range that arises because of the results achieved
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`in Example 7. Specifically, Example 7 showed that the dose in Example 3—which
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`relates directly to the CRPS—could be reduced because some forms of zoledronic
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`acid, such as the disodium salt form, are more bioavailable than was previously
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`known or understood. This second aspect of the invention was added to the
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`1
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`Post-Grant Review of U.S. Patent No. 9,283,239
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`disclosure when the continuation-in-part was filed on October 25, 2013, as
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`PGR2017-00008
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`application number 14/063,979. (Ex. 2017, U.S. Patent Application Publ’n No. US
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`2014/0051669 A1 (published Feb. 20, 2014 (hereinafter, the “’669 Application”)).
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`Both of these applications had been published by March 2, 2015, when the related
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`application for the ’239 patent was filed, so both were part of the knowledge of a
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`person of ordinary skill in the art (hereinafter, “POSA”) as of that date. (Ex. 2016,
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`’488 Application (published Nov. 14, 2013); Ex. 2017, ’669 Application (published
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`Feb. 20, 2014.) For this reason, a POSA would have understood that Example 3,
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`which Petitioner erroneously contends shows a lack of support for the claimed range
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`in the specification—in fact provides explicit support for the range of about 80 mg
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`to about 500 mg recited in independent claim 1 of the ’239 Patent.
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`This express written support in the specification, as well as others, are
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`discussed in more detail below.
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`II.
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` A PERSON SKILLED IN THE ART
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`
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`Before addressing the substantive arguments, Patent Owner addresses the
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`definition of a person skilled in the art (“POSA”). The Board, in its decision, noted
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`that a POSA would have an M.D. (Petition at 9, n. 10 (“The parties agree that a
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`POSA would have a medical degree”). Patent Owner agrees. As previously set
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`forth in its Preliminary Response, in addition to an M.D., a POSA as it pertains to
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`the ,239 Patent at the relevant time (as early as May 14, 2012), and in particular as
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`2
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`Post-Grant Review of U.S. Patent No. 9,283,239
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`it relates to determining the dosage regimens, would have experience treating
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`PGR2017-00008
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`patients with intravenous and oral bisphosphonates and/or conducting research
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`involving intravenous and oral bisphosphonates. (Ex. 2001 at ¶16; Ex. 2002 at ¶12;
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`Ex. 2015, Second Expert Declaration of Dr. Socrates Papapoulos (hereinafter,
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`“Second Papapoulos Decl.”) at ¶19.)
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`
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`This additional qualification is necessary because bisphosphonates are an
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`unusual category of drug, with characteristics that prevent them from being used like
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`other pain medications. (See, e.g. Ex. 2001 at ¶¶23–34, Ex. 2015, Second Papapoulos
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`Decl., at ¶19). Further, bisphosphonates also have significantly different
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`pharmacology from pain medications. (Ex. 2015, Second Papapoulos Decl., at ¶19.)
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`As a result, an M.D. without the relevant experience and qualifications would not
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`understand
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`the
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`important and clinically
`
`relevant properties unique
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`to
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`bisphosphonates with regard to dosing regimens. (Ex. 2015, Second Papapoulos
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`Decl., at ¶ 19.) Thus, as well as the medical degree the Board and Petitioners agree
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`is necessary, specific experience with CRPS and/or bisphosphonates is necessary for
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`someone to be considered to be a POSA.
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`III. PETITIONER MUST CARRY ITS BURDEN, IF AT ALL, IN ITS
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`PETITION
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`Petitioner has not carried its burden in its petition. The only issue on trial is
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`whether the dosing regimen of “about 80 to about 500 mg of zoledronic acid within
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`3
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`Post-Grant Review of U.S. Patent No. 9,283,239
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`a period of six months” is adequately supported by the written description. (Decision
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`at 32.) Under 35 U.S.C. § 326(e), “the petitioner shall have the burden of proving a
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`proposition of unpatentability by a preponderance of the evidence.” While the
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`petition can include supporting exhibits (35 U.S.C. § 322(a)(3)), and petitioners are
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`allowed a reply to address a patent owner’s responsive arguments (37 C.F.R.
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`§ 42.23(b)), these provisions mean essentially that a petitioner must carry its burden,
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`if at all, in the petition.
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`The Federal Circuit has reinforced this point on a number of occasions. First,
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`in Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., the court explained that “[i]t
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`is of the utmost importance that petitioners in the IPR proceedings adhere to the
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`requirement that the initial petition identify ‘with particularity’ the ‘evidence that
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`supports the grounds for the challenge to each claim.’” 821 F.3d 1359, 1369 (Fed.
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`Cir. 2016) (quoting 35 U.S.C. § 312(a)(3)).1 The court reasoned that, “[u]nlike
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`1 Inter partes review (IPR) proceedings are procedurally indistinguishable from
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`post-grant review (PGR) proceedings on the requirements that (1) “the petitioner
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`shall have the burden of proving a proposition of unpatentability by a
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`preponderance of the evidence” (compare 35 U.S.C. § 316(e) with 35 U.S.C.
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`§ 326(e)) and that “the petition identif[y], in writing and with particularity, each
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`claim challenged, the grounds on which the challenge to each claim is based, and
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`4
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`Post-Grant Review of U.S. Patent No. 9,283,239
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`district court litigation—where parties have greater freedom to revise and develop
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`PGR2017-00008
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`their arguments over time and in response to newly discovered material—the
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`expedited nature of IPRs bring with it an obligation for petitioners to make their case
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`in their petition to institute.” Id. The court thus held that the Board did not abuse its
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`discretion when it excluded the petitioner’s reply brief and supporting declaration as
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`advancing arguments and evidence not included in the petition. Id. at 1370.
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`The Federal Circuit went a step further a few months later in In re Magnum
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`Oil Tools Int’l, Ltd., 829 F.3d 1364 (Fed. Cir. 2016). First, the court rejected the
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`proposition that a decision to institute trial shifts the burden of persuasion (i.e., the
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`ultimate burden of proof) to the patent owner to establish patentability. In re
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`Magnum, 829 F.3d at 1375–77 (Fed. Cir. 2016). The court held that “it is
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`inappropriate to shift the burden to the patentee after institution to prove that the
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`patent is patentable,” and that “the petitioner continues to bear the burden of proving
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`unpatentability after institution, and must do so by a preponderance of the evidence
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`at trial.” Id.
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`the evidence that supports the grounds for the challenge to each claim” (compare
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`35 U.S.C. § 312(a)(3) with 35 U.S.C. § 322(a)(3)). Decisions interpreting and
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`applying these provisions in IPR proceedings are equally applicable to and, where
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`precedential, binding upon PGR proceedings.
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`Building on this holding, the Magnum court also rejected the petitioner’s
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`argument that the Board had a duty to consider all possible arguments against
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`patentability, even those not raised, or raised late, by the petitioner. Id. at 1380–81.
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`Because the system is one “predicated on a petition followed by a trial in which the
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`petitioner bears the burden of proof,” the court determined that “the Board must base
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`its decision on arguments that were advanced by a party, and to which the opposing
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`party was given a chance to respond.” Id. at 1381. The Board may not “raise, address,
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`and decide unpatentability theories never presented by the petitioner and not
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`supported by record evidence.” Id. By the same logic, and under the law of Illumina,
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`the petitioner may not raise new arguments against patentability for the first time in
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`its reply brief. Illumina, 821 F.3d at 1369–70.
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`Why this matters in the present case is that Petitioner had a job to do in its
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`petition vis-à-vis written description. It had to show, by a preponderance of the
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`evidence, that all the claims it nominally challenged lack written description support.
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`Petitioner nominally challenged claims 1–17 as lacking written description support,
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`but its substantive argument was limited to claim 1. (Petition at 19–24.) Petitioner
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`chose not to address the issue of written description support for claims 2–17 in any
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`substantive regard, except to imply that they too would be unsupported because they
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`depend from and thus incorporate claim 1. (Petition at 19–20.)2 Illumina holds that
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`Petitioner may not press new arguments about claim 1, nor may it present any
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`arguments regarding claims 2–17, for the first time in its reply papers. Illumina, 821
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`F.3d at 1369. Magnum further makes clear that the Board’s institution of trial as to
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`whether claims 1–17 are supported by the written description does not in any way
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`shift the burden of persuasion to Patent Owner, nor does it impose a burden of
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`production to address or defend claims 2–17, except to the extent they incorporate
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`the limitations of claim 1. Magnum, 829 F.3d at 1376–1377.3 Moreover, because
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`2 Petitioner did separately address claim 17, but the Board rejected that challenge.
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`(Decision at 20–22.) Petitioner’s separate challenge to claim 17 is significant
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`nonetheless, however, as it shows a deliberateness in Petitioner’s decision to not
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`give each of the other dependent claims such separate attention.
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`3 “[T]here are two distinct burdens of proof: a burden of persuasion and a burden
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`of production. The burden of persuasion is the ultimate burden assigned to a party
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`who must prove something to a specified degree of certainty, such as by a
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`preponderance of the evidence or by clear and convincing evidence. A distinct
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`burden, the burden of production may entail producing additional evidence and
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`presenting persuasive argument based on new evidence or evidence already of
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`record. In an inter partes review, the burden of persuasion is on the petitioner to
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`“the Board must base its decision on arguments that were advanced by a party, and
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`to which the opposing party was given a chance to respond,” Patent Owner need
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`only address herein the arguments actually raised by Petitioner. Id. at 1381.
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`The institution of trial means only that the Board decides whether Petitioner
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`has carried its burden of persuasion; it is not a de novo examination where the Board
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`may “raise, address, and decide unpatentability theories never presented by the
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`petitioner.” Id. If the Board is left uncertain after having reviewed all the arguments
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`supporting or opposing the points Petitioner actually raised in the petition, then
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`Petitioner loses and the challenged claims must stand. Dynamic Drinkware, LLC v.
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`Nat'l Graphics, Inc., 800 F.3d 1375, 1378–79 (Fed. Cir. 2015) (“Failure to prove the
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`matter as required by the applicable standard means that the party with the burden
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`of persuasion loses on that point—thus, if the fact trier of the issue is left uncertain,
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`the party with the burden loses.” (citation and quotation marks omitted)).
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`With that background in mind, Patent Owner identifies and discusses below a
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`number of places in the specification of the ’239 patent that expressly support the
`
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`prove ‘unpatentability by a preponderance of the evidence,’ 35 U.S.C. § 316(e),
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`and that burden never shifts to the patentee.” Magnum, 829 F.3d at 1375 (citations
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`and internal quotation marks omitted).
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`challenged limitation of “about 80 to about 500 mg of zoledronic acid within a period
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`PGR2017-00008
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`of six months.”
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`IV. PETITIONER HAS NOT SHOWN BY A PREPONDERANCE OF THE
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`EVIDENCE THAT THE CLAIMS OF THE ’239 PATENT LACK
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`WRITTEN DESCRIPTION SUPPORT
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`In the present case, the petition dedicates just five-and-a-half pages to the
`
`issue of whether the written description supports the dosing regimen described in
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`claim 1: “about 80 to about 500 mg of zoledronic acid within a period of six months.”
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`(Petition at 19–24.) It is here (and in the supporting attachments) where Petitioner
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`must carry its burden, if at all. Petitioner’s discrete arguments are, generally stated:
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`(1) the claimed range is found nowhere in the specification, and was first introduced
`
`as an amendment to the claims during prosecution (Petition at 21); (2) the
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`specification states many ranges but does not direct a POSA to the claimed range
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`(Petition at 21–23); (3) Example 3 (one of six separately described examples) does
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`not support the claimed regimen (Petition at 23); and (4) certain passages selected
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`by Petitioner do not support the six-month aspect of the claimed dosing regimen
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`(Petition at 24). These arguments are all either strawmen or falsely premised and, as
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`a result, fail to show lack of written description by a preponderance of the evidence.
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`Petitioner’s first argument, for example, is simply false. It is not true that the
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`range of “about 80 to about 500 mg” appears nowhere in the specification. Sections
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`B and C, below, provide considerable detail as to where this range is found. For this
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`reason, Petitioner’s second argument, which purports to invoke Purdue Pharma L.P.
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`v. Faulding Inc., 230 F.3d 1320, 1327 (Fed. Cir. 2000), is demonstrably a strawman.
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`This is not a case where Patent Owner “disclose[d] a forest in the original
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`application, and then later pick[ed] a tree out of the forest and sa[id] here is my
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`invention,” so Purdue Pharma is not controlling. Purdue Pharma, 230 F.3d at 1327.
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`Purdue Pharma, unlike this case, involved the addition of a claim limitation in the
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`form of a pharmacological property that was nowhere even discussed in the
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`specification. In marked contrast, and as detailed below, the ’239 specification as
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`originally filed expressly identifies the claimed dosing regimen.
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`Petitioner’s third argument is a strawman. Just because one Example does not
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`support the written description, does not mean there is no support elsewhere in the
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`specification. In any event, Petitioner is also wrong for the very reason that
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`Petitioner ignores a large portion of the disclosure in the patent. Based upon
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`revisions to the disclosure that Patent Owner made in earlier, already published
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`applications and patents, Example 3 actually demonstrates that the inventor was in
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`possession of the range of the patented claims. As explained below in Section B.3,
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`a POSA would have understood Example 3 at the time of filing to directly support
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`the claimed dosing range, when read in light of the teaching of Example 7. Because
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`Peitioner’s expert, Dr. Bruehl, is a psychologist who lacks an M.D., he was not and
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`is not in a position to say what a POSA would have understood from reading these
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`examples. Indeed, as someone who lacks an M.D., he is not licensed to administer
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`dosages of bisphosphonates or other pain relievers and presumably has never done
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`so.
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`With respect to the fourth argument, Patent Owner does not contend that the
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`six-month time period is found at columns 25 and 26, so Petitioner’s contention
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`regarding these passages does nothing to shoulder its burden of showing lack of
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`written description support. The six-month period, for reasons explained below in
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`Sections B and C, is amply supported by the ’239 disclosure, and a POSA would
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`have understood the Patent Owner to have been in possession of the invention as
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`claimed.
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`Without even turning to the showing Patent Owner makes below, the Board
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`could and should reject Petitioner’s written description arguments as insufficient due
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`to lack of relevance and false premise. Nonetheless, Patent Owner provides below
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`an affirmative demonstration of several different ways that the dosing regimen of
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`claim 1 enjoys written description support.
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`A. The written description inquiry asks whether the disclosure
`conveys to those skilled in the art that the inventor had possession
`of the claimed subject matter.
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`“To adequately support the claims, the written description ‘must clearly allow
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`persons of ordinary skill in the art to recognize that the inventor invented what is
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`claimed.’” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1344 (Fed. Cir.
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`2016) (quoting Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir.
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`2010) (en banc) (internal quotation marks and brackets omitted)). “[W]hatever the
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`specific articulation, the test requires an objective inquiry into the four corners of the
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`specification from the perspective of a person of ordinary skill in the art.” Ariad, 598
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`F.3d at 1351. “Based on that inquiry, the specification must describe an invention
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`understandable to that skilled artisan and show that the inventor actually invented
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`the invention claimed.” Id. “There is no requirement that the disclosure contain
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`either examples or an actual reduction to practice; rather, the critical inquiry is
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`whether the patentee has provided a description that in a definite way identifies the
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`claimed invention in sufficient detail that a person of ordinary skill would understand
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`that the inventor was in possession of it at the time of filing.” Alcon Research Ltd.
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`v. Barr Labs., Inc., 745 F.3d 1180, 1190–91 (Fed. Cir. 2014) (citations and quotation
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`marks omitted).
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`The applicant does not have to describe exactly the subject matter claimed, so
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`long as the description clearly allows “persons of ordinary skill in the art to recognize
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`that [he or she] invented what is claimed.” Vas-Cath Inc. v. Mahurkar, 935 F.2d
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`1555, 1562 (Fed. Cir. 1991) (citing In re Gosteli, 872 F.2d 1008, 1012, 10 U.S.PQ.2d
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`1614, 1618 (Fed. Cir 1989).); Ex Parte Jung-Sheng Wu and Raghunath Padiyatgh,
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`110 U.S.P.Q. 561 (PTAB 2016) (exemplified values in the original specification can
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`be used to derive a range of such values without violating the written description
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`requirement) (citations omitted); Ex Parte Juan Mantelle, Appeal No. 2015-004605,
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`2017 WL 2200409 (PTAB 2017) (written description requirement met where
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`claimed range could be constructed from other ranges and data points disclosed in
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`the specification). The proper inquiry in the present case is thus whether the
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`disclosure of the ’239 Patent reasonably would have conveyed to those skilled in the
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`art at the time of filing that the inventor had possession of the claimed dosing
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`regimen of “about 80 to about 500 mg of zoledronic acid within a period of six
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`months.”
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`B. Written description support exists for the dosage range about 80
`mg to about 500 mg over a six-month period.
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`Contrary to Petitioner’s argument, the dosage range of about 80 mg to about
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`500 mg within a six month period is disclosed in the ’239 Patent specification such
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`that a POSA would have understood that the patentee was in possession of the
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`claimed invention.
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`1.
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`The dosage range about 80 mg to about 500 mg within a six-
`month period is expressly disclosed at column 10, lines 47
`and 60–62, and in combination with column 13, lines 27–33.
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`Explicit support can be found at column 10 for administering a dosage of about
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`500 mg over 6 months, and explicit support can be found at column 13 for
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`administering about 80 mg over 6 months. Specifically, column 10, lines 47 and
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`60–62 disclose a dosing regimen of “about 100 mg to about 500 mg . . .
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`administered . . . twice a year, thus disclosing, the upper limit “about 500 mg”
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`dosage over 6 months verbatim, and also the lower limit “about 80 mg” over 6
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`months dosage, rounded up to 100 mg. (Ex. 1003, U.S. Patent No. 9,283,239
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`(hereinafter, the “’239 patent”); Ex. 2015, Second Papapoulos Decl., at ¶26.)
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`Furthermore, column 13, lines 27–33, disclose a dosing regimen of about 10 mg
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`per day and a dosing period of eight consecutive days (totaling 80 mg) with a
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`repetition of the cycle for the dosing period of “once every six months,” thus
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`disclosing a dosage of 80 mg within a six-month period, the lower limit of the
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`range. (Ex. 1003, ’239 patent, Ex. 2015, Second Papapoulos Decl., at ¶28.)
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`Furthermore, this same dosing regimen of 10 mg per day for eight consecutive
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`days can be “repeated once monthly.” (Ex. 1003, ’239 patent, at col. 13, li