Antecip Bioventures II LLC

Patent Trials and Appeals Board

Jul 28, 2020

PGR2019-00028 (P.T.A.B. Jul. 28, 2020)

Trials@uspto.gov Paper 25
Tel: 571-272-7822 Date: July 28, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

GRÜNENTHAL GMBH,
Petitioner,
v.
ANTECIP BIOVENTURES II LLC,
Patent Owner.

PGR2019-00028
Patent 10,052,338 B2

Before GRACE KARAFFA OBERMANN, CHRISTOPHER M. KAISER,
and WESLEY B. DERRICK, Administrative Patent Judges.
KAISER, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining All Claims Unpatentable
35 U.S.C. § 328(a)

PGR2019-00028
Patent 10,052,338 B2
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INTRODUCTION
A. Background
Grünenthal GmbH (“Petitioner”) filed a Petition (Paper 2, “Pet.”)
requesting a post-grant review of claims 1–30 of U.S. Patent No. 10,052,338
B2 (Ex. 1003, “the ’338 patent”). Antecip Bioventures II LLC (“Patent
Owner”) did not file a Preliminary Response. We instituted review of all
challenged claims on each of the grounds asserted in the Petition. Paper 6
(“Dec. Inst.”).
Following institution, Patent Owner filed a Response (Paper 11, “PO
Resp.”), Petitioner filed a Reply (Paper 13, “Reply”), and Patent Owner filed
a Sur-Reply (Paper 16, “PO Sur-Reply”). Patent Owner also filed a motion
to exclude certain evidence. Paper 21 (“Mot. Exclude”). Petitioner opposed
this motion (Paper 22, “Opp. Mot.”), and Patent Owner filed a Reply
(Paper 23, “Reply Mot.”). We held a hearing on April 24, 2020, the
transcript of which has been entered into the record. Paper 24.
We have jurisdiction under 35 U.S.C. § 6, and we issue this Final
Written Decision pursuant to 35 U.S.C. § 328(a). We conclude that
Petitioner has established by a preponderance of the evidence that claims 1–
30 of the ’338 patent are unpatentable.
B. Related Matters
The parties do not direct us to any judicial matter that would be
affected by the outcome of this proceeding. Pet. 5–6; Paper 3, 2. Petitioner
has, however, challenged patents related to the ’338 patent in additional
petitions. Pet. 5; Paper 3, 2. In particular, according to the parties, the
Board has issued final written decisions in PGR2017-00008 and PGR2017-
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Patent 10,052,338 B2
3
00022, and petitions are pending in PGR2018-00001,1 PGR2018-00062,
PGR2019-00003, PGR2019-00026, and PGR2019-00027. Id.
C. The Asserted Grounds of Unpatentability
Petitioner contends that claims 1–30 of the ’338 patent are
unpatentable based on the following grounds (Pet. 24–78):2
35 U.S.C.
§
References/Basis Challenged Claims
103 Varenna 2011,3 Gatti,4 and/or
Muratore;5 and Harden6

1–16

1 After the parties identified related matters, the Board issued a final written
decision in PGR2018-00001. See PGR2018-00001, Paper 48 (PTAB
Apr. 29, 2019).
2 Petitioner also relies on a Declaration from Lawrence Poree, M.D., Ph.D.
Ex. 1004.
3 Massimo Varenna, The Clinical Framework of Algodystrophy (Complex
Regional Pain Syndrome Type I), An Update, 37 IT. J. ORTHOPEDICS &
TRAUMATOLOGY 227, 227–34 (Oct. 2011) (Ex. 1006, “Varenna 2011”)
(English translation).
4 Davide Gatti, Ombretta Viapiana, Luca Idolazzi, Elena Fracassi & Silvano
Adami, Neridronic Acid for the Treatment of Bone Metabolic Diseases,
5 EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY 1305, 1305–11
(2009) (Ex. 1008, “Gatti”).
5 M. Muratore, F. Calcagnile, L. Cosentino, M. Serra, C. Circhetta, & E.
Quarta, Neridronate in the Treatment of Reflex Sympathetic Hip
Algodystrophy: Open Comparison with Clodronate, PROGRESS IN
RHEUMATOLOGY (Apr. 2004) (Ex. 1007, “Muratore”) (English translation).
6 R. Norman Harden, Stephen Bruehl, Roberto S.G.M. Perez, Frank
Birklein, Johan Marinus, Christian Maihofner, Timothy Lubenow,
Asokumar Buvanendran, Sean Mackey, Joseph Graciosa, Mila Mogilevski,
Christopher Ramsden, Melissa Chont, & Jean-Jacques Vatine, Validation of
Proposed Diagnostic Criteria (the “Budapest Criteria”) for Complex
Regional Pain Syndrome, 150 PAIN 268, 268–74 (Apr. 2010) (Ex. 1009,
“Harden”).
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35 U.S.C.
§
References/Basis Challenged Claims
112 Indefiniteness

17–30
103 Varenna 2011, Gatti, and/or
Muratore; Harden; and
Drummond7

17–30
112 Written Description

1–30
D. The ’338 Patent
The ’338 patent, titled “Neridronic Acid for Treating Complex
Regional Pain Syndrome,” issued on August 21, 2018. Ex. 1003, code (45),
(54). The ’338 patent relates to “[o]ral dosage forms of osteoclast inhibitors,
such as neridronic acid, in an acid form or a salt form” that “can be used to
treat or alleviate pain or related conditions, such as allodynia associated with
complex regional pain syndrome.” Id. at code (57). According to the patent,
“[b]isphosphonate compounds are potent inhibitors of osteoclast activity,
and are used clinically to treat bone-related conditions such as osteoporosis
and Paget’s disease of bone,” as well as “cancer-related conditions including
multiple myeloma, and bone metastases from solid tumors,” but these
compounds “generally have low oral bioavailability.” Id. at 1:58–63.
“[O]ral dosage forms of bisphosphonate compounds . . . can be used to treat
or alleviate pain or related conditions.” Id. at 2:3–5. One of these
conditions is “allodynia . . . after a precipitating event such as fracture that is

7 Peter D. Drummond, Sensory Disturbances in Complex Regional Pain
Syndrome: Clinical Observations, Autonomic Interactions, and Possible
Mechanisms, 11 Pain Medicine 1257, 1257–66 (2010) (Ex. 1010,
“Drummond”).
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associated with [complex regional pain syndrome],” which “is a debilitating
pain syndrome” that “is characterized by severe pain in a limb that can be
accompanied by edema, and autonomic, motor and sensory changes.” Id. at
3:19–24, 13:23–26.
None of the figures or working examples in the specification of
the ’338 patent relate to the use of neridronic acid. Id. at 3:28–4:18, 49:15–
63:18, Figs. 1–16 (all discussing the use of zoledronic acid). Nevertheless,
the specification identifies neridronic acid as a bisphosphonate suitable for
use in the invention and contains information pertaining to daily oral dosing
of neridronic acid. Id. at 3:19–24, 31:26–31. The specification also refers to
a “molecular complex comprising neridronic acid” that “is administered in
an amount that results in” certain disclosed blood plasma concentration
curves. Id. at 26:16–29. Moreover, the specification contains other general
information pertaining to the dosing of neridronic acid. For example, the
’338 patent describes the administration of “[a]ny suitable amount of an
osteoclast inhibitor, including a bisphosphonate,” from a list that includes
“neridronic acid” and identifies broad dosing ranges (from about 0.005 mg
to about 2000 mg). Id. at 33:12–44. The patent also describes the
administration of “any amount of osteoclast inhibitor” that is “in a range
bounded by, or between, any of these values.” Id. The specification
compares oral forms of bisphosphonates to “parenteral modes of
administration, such [as] intravenous or subcutaneous” modes. Id. at 26:43–
47.
E. Illustrative Claims
Claims 1–30 of the ’338 patent are challenged. Claims 1 and 17 are
independent and illustrative; they recite:
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1. A method of treating allodynia associated with complex
regional pain syndrome, comprising parenterally
administering neridronic acid in a salt form or an acid form
to a human being suffering from allodynia associated with
complex regional pain syndrome.
Ex. 1003, 89:27–31.
17. A method of treating autonomic motor change associated
with complex regional pain syndrome, comprising
administering neridronic acid in a salt form or an acid form
to a human being suffering from autonomic motor change
associated with complex regional pain syndrome.
Id. at 90:17–21.
ANALYSIS
A. Eligibility of the ’338 Patent for Post-Grant Review
Post-grant reviews are available only for patents “described in section
3(n)(1)” of the Leahy-Smith America Invents Act (“AIA”), Pub L. No. 112-
29, 125 Stat. 284 (2011). AIA § 6(f)(2)(A). These patents are those that
issue from applications “that contain[] or contained at any time . . . a claim
to a claimed invention that has an effective filing date as defined in section
100(i) of title 35, United States Code, that is on or after” “the expiration of
the 18-month period beginning on the date of the enactment of” the AIA.
Id. § 3(n)(1). Because the AIA was enacted on September 16, 2011, post-
grant reviews are available only for patents that issue from applications that
at one point contained at least one claim with an effective filing date on or
after March 16, 2013, with “effective filing date” having the definition given
to it by 35 U.S.C. § 100(i). The effective filing date of an application for a
patent on an invention is “the filing date of the earliest application for which
the . . . application is entitled, as to such invention, to a right of priority
under section 119, 365(a), 365(b), 386(a), or 386(b) or to the benefit of an
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earlier filing date under section 120, 121, 365(c), or 386(c).” 35 U.S.C.
§ 100(i)(1)(B).
Petitioner notes that the ’338 patent claims priority to several
applications filed before March 16, 2013, but argues that it nevertheless is
eligible for post-grant review because it “contains . . . at least one claim that
was not disclosed in compliance with the written description and enablement
requirements of § 112(a) in the” applications to which it claims priority.
Pet. 20 (quoting Inguran, LLC v. Premium Genetics (UK) Ltd., PGR2015-
00017, Paper 8 at 11 (PTAB Dec. 22, 2015)). Specifically, Petitioner argues
that none of the applications to which the ’338 patent claims priority
sufficiently describes claims 10–13 or 26–29. Id. at 21–23. Those claims
recite limitations regarding the age of patients being treated or the duration
of the patient’s suffering from complex regional pain syndrome. Ex. 1003,
89:56–90:5, 90:47–57. According to Petitioner, none of the priority
applications describe these limitations. Pet. 21–23.
In our Decision on Institution, based on Petitioner’s representations,
we preliminarily found that the ’338 patent was eligible for post-grant
review. Dec. Inst. 6–7. We noted that “Patent Owner may dispute that
finding in a timely-filed response to the Petition.” Id. at 7. Patent Owner
did not dispute our finding or otherwise argue that the ’338 patent was
ineligible for post-grant review in its Response. PO Resp. 1–27.
Accordingly, we find that the ’338 patent is eligible for post-grant review.
B. Claim Construction
In a post-grant review, we construe claim terms in an unexpired patent
“in accordance with the ordinary and customary meaning of such claim as
understood by one of ordinary skill in the art and the prosecution history
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pertaining to the patent,” as the claims would be construed “in a civil action
under 35 U.S.C. 282(b).” 37 C.F.R. § 42.200(b) (2018). Only terms which
are in controversy need to be construed, and then only to the extent
necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g,
Inc., 200 F.3d 795, 803 (Fed. Cir. 1999).
The parties propose construing two terms. First, the parties dispute
whether the preambles of the challenged claims should be treated as limiting
the scope of those claims. Pet. 16–19; PO Resp. 2–5; Reply 1–2; PO Sur-
Reply 1. Second, the parties disagree about how we should interpret the
phrase “autonomic motor change” in claims 17–30. PO Resp. 4–5; Reply 3;
PO Sur-Reply 1–2.
1. Preambles of the Challenged Claims
Claim 1 of the ’338 patent recites “[a] method of treating allodynia
associated with complex regional pain syndrome.” Ex. 1003, 89:27–31.
Claim 17 similarly recites “[a] method of treating autonomic motor change
associated with complex regional pain syndrome.” Id. at 90:17–21.
Petitioner argues that these preambles should not be interpreted as limiting
the scope of the challenged claims. Pet. 16–18; Reply 1–2. Patent Owner
disagrees, arguing that the preambles should be construed as limiting. PO
Resp. 2–5; PO Sur-Reply 1.
The result of Petitioner’s unpatentability challenges would not change
regardless of whether the preambles are limiting. Even if the preambles are
limiting, their scope is so broad as to be hardly different from no limitation
at all. The specification of the ’338 patent defines “treating” as “includ[ing]
any kind of treatment activity, including the diagnosis, cure, mitigation, or
prevention of disease in man or other animals, or any activity that otherwise
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affects the structure or any function of the body of man or other animals.”
Ex. 1003, 7:43–47. This definition exhibits “reasonable clarity,
deliberateness, and precision” and is “‘set out . . . within the patent
disclosure’ so as to give one of ordinary skill in the art notice of the change”
in meaning. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994) (quoting
Intellicall, Inc. v. Phonometrics, Inc., 952 F.2d 1384, 1387–88 (Fed. Cir.
1992)). Accordingly, we give effect to this definition of “treating.”
Under the definition of “treating” in the specification of the ’338
patent, “[a] method of treating allodynia associated with complex regional
pain syndrome” means a method of diagnosing, curing, mitigating, or
preventing allodynia associated with complex regional pain syndrome, or
otherwise affecting the structure or any function of the body of someone
suffering from allodynia associated with complex regional pain syndrome.8
To the extent that this requires carrying out the method on a patient suffering
from allodynia (or autonomic motor change) associated with complex
regional pain syndrome, this is already part of the method recited in the body
of the claims, Ex. 1003, 89:27–31, 90:70–21, so the preambles provide no
additional limitation. To the extent that the preambles require some
particular result to be brought about, that result could be the diagnosis, cure,
mitigation, or prevention of the allodynia (or autonomic motor change) in
question, or it could be any effect at all on the structure or any function of

8 Similarly, “[a] method of treating autonomic motor change associated with
complex regional pain syndrome” means a method of diagnosing, curing,
mitigating, or preventing autonomic motor change associated with complex
regional pain syndrome, or otherwise affecting the structure or any function
of the body of someone suffering from autonomic motor change associated
with complex regional pain syndrome.
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the patient’s body. Thus, even when construed as limiting, the preambles
impose little, if any, further restriction on the scope of the challenged claims
beyond that set forth in the body of the claims.
Moreover, as discussed below with respect to the asserted grounds of
obviousness, Petitioner directs us to evidence that the prior art teaches or
suggests the subject matter of the preambles even when those preambles are
construed as limiting in accordance with the meaning of “treating” provided
in the specification.9 Thus, regardless of whether we treat the preambles as
limiting or not, we would resolve this case the same way. Given this, we
treat the preambles of the challenged claims as limiting, and we give them a
meaning consistent with the specification’s definition of “treating.”
2. “Autonomic Motor Change”
Claim 17 recites the phrase “autonomic motor change.” Ex. 1003,
90:17–21. Petitioner did not originally argue that we should construe
“autonomic motor change,” but Petitioner did argue that a person of ordinary
skill in the art would not have been able to understand the meaning of the
phrase. Pet. 14–19, 50–52. Specifically, Petitioner argued that “‘autonomic’
changes and ‘motor’ changes are actually two different types of changes”
and that a person of ordinary skill in the art would not have understood
“whether the ‘autonomic motor change’ of claims 17–30 covered . . .
autonomic changes associated with CRPS, motor changes associated with
CRPS, or both.” Id. at 51–52. Patent Owner argues that, to the contrary, a
person of ordinary skill in the art would have known that “autonomic motor

9 The asserted grounds of unpatentability other than obviousness can be
resolved without deciding whether the preambles of the challenged claims
are limiting.
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change” meant “changes such as changes in skin blood flow, changes in
temperature, such as temperature asymmetry, and sweating changes.”
PO Resp. 4–5. In the Reply, Petitioner argues that there is no record
evidence to support Patent Owner’s proposed construction and that the
phrase “autonomic motor change” should be construed as “autonomic
dysfunction associated with CRPS, motor changes associated with CRPS, or
both.” Reply 3.
The parties’ arguments thus present us with two choices for the proper
construction of “autonomic motor change.” First, we could construe the
term as “autonomic dysfunction associated with CRPS, motor changes
associated with CRPS, or both,” as Petitioner argues. Alternatively, we
could construe the phrase as “changes such as changes in skin blood flow,
changes in temperature, such as temperature asymmetry, and sweating
changes,” as Patent Owner argues. We agree with Patent Owner.
Petitioner’s position, that “autonomic motor change” must mean
something like “autonomic change or motor change” is based on two pieces
of evidence. First, Petitioner directs us to a statement in the specification of
the ’338 patent that refers to “autonomic, motor and sensory changes.”
Ex. 1003, 13:23–26. According to Petitioner, this phrase suggests three
possible types of change: autonomic changes, motor changes, and sensory
changes. Under this interpretation, the phrase “autonomic motor change”
represents a combination of the first two types. Second, Petitioner directs us
to the testimony of Dr. Poree, who states that a person of ordinary skill in the
art “would have known that . . . CRPS is associated with both autonomic
changes . . . and somatic motor changes” and would not have known
whether claims 17–30 covered “autonomic changes associated with CRPS,
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somatic motor changes associated with CRPS, or both.” Ex. 1004 ¶¶ 136–
137.
Patent Owner, by contrast, directs us to evidence that supports
knowledge in the art of a biological system called the “autonomic motor
system.” Ex. 2002, 1056–57. Specifically, the evidence shows that the
“autonomic motor system regulates gland cells as well as smooth and
cardiac muscle, maintains constant body temperature, and controls eating,
drinking, and sexual behavior.” Id. at 1056. “The autonomic motor system
is distinct from the somatic motor system, which controls skeletal muscle.”
Id. Petitioner’s proposed construction is inconsistent with the knowledge in
the art of the “autonomic motor system,” because it ignores the existence of
such a system. Given that a person of ordinary skill in the art would have
known of the “autonomic motor system,” it seems reasonable to conclude
that person would have given the phrase “autonomic motor change” its plain
meaning by interpreting it as “changes in the autonomic motor system.”
This leaves the question of whether interpreting “autonomic motor
change” in this way is consistent with Petitioner’s evidence. It clearly is
consistent with the statement in the specification of the ’338 patent that
refers to “autonomic, motor and sensory changes.” Ex. 1003, 13:23–26. If
“autonomic motor change” is interpreted as “changes in the autonomic
motor system,” then “autonomic, motor and sensory changes” may be
interpreted as “changes in the autonomic motor system, somatic motor
system, or sensory system.” See Ex. 1004 ¶¶ 135–137 (associating “somatic
motor changes” with the “motor . . . changes” mentioned in the specification
of the ’338 patent); Ex. 2002, 1056 (distinguishing the autonomic motor
system from the somatic motor system). To the extent that this
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interpretation is inconsistent with the testimony of Petitioner’s declarant,
Dr. Poree, that a person of ordinary skill in the art “would not have
understood with reasonable certainty what the claimed ‘autonomic motor
change’ associated with CRPS refers to,” Ex. 1004 ¶ 137, we note that
Dr. Poree does not cite any evidence in support of this conclusion.
Accordingly, this testimony is unhelpful in resolving the meaning of the
phrase. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281,
294 (Fed. Cir. 1985) (a lack of objective support for an expert opinion “may
render the testimony of little probative value”).
After considering the evidence of record and the parties’ arguments,
we conclude that a person of ordinary skill in the art would have understood
“autonomic motor change” to mean “changes in the autonomic motor
system.” Patent Owner argues that these changes include “changes in skin
blood flow, changes in temperature, such as temperature asymmetry, and
sweating changes.” PO Resp. 4–5. This statement is supported by evidence
of record. Ex. 2002, 1056 (phenomenon of “palms becom[ing] sweaty” is
“mediated by the autonomic motor system”; “the autonomic motor
system . . . maintains constant body temperature”), 1057 (describing control
of “vascular resistance to blood flow” as “mediated by hypothalamic control
of the autonomic motor system”). Accordingly, we construe “autonomic
motor change” as “changes in the autonomic motor system, such as changes
in skin blood flow, changes in temperature, such as temperature asymmetry,
and sweating changes.”
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C. Asserted Obviousness over Harden and One or More of Varenna
2011, Gatti, and Muratore
Petitioner argues that the subject matter of claims 1–16 would have
been obvious to a person of ordinary skill in the art given the teachings of
Harden and one or more of Varenna 2011, Gatti, and Muratore. Pet. 24–49.
1. Varenna 2011
Varenna 201110 relates to “[t]he Clinical Framework of
Algodystrophy,” which is also referred to as “Complex Regional Pain
Syndrome Type I” or “Algodystrophic Syndrome.” Ex. 1006, 227, 228.
According to Varenna 2011, the “Budapest Criteria” are “used for the
diagnosis of” CRPS:
1. Continuous pain disproportionate to the triggering
event
2. Patient must report the presence of at least one
symptom in three of the following four categories:
• Sensory changes: hyperesthesia and/or
allodynia
• Vasomotor changes: asymmetry of warmth
when touched and/or change and/or asymmetry
of skin color
• Sudomotor changes/edema: edema and/or
perspiration anomalies and/or asymmetry
• Motor/trophic changes: reduced range of
motion and/or motor anomalies (hyposthenia,
tremors, dystonia) and/or trophic changes (skin,
nails, hair follicles)
3. At least one sign in two or more of the following
categories must be objectivized:

10 Varenna 2011 originally was written in Italian, but we refer to the English
translation Petitioner submitted.
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• Sensory changes: hyperalgesia and/or allodynia
• Vasomotor changes: evidence of asymmetry in
contact with heat and/or change and/or
asymmetry of skin color
• Sudomotor changes/edema: evidence of di
edema and/or perspiration anomalies and/or
asymmetry
• Motor/trophic changes: evidence of: reduced
range of motion and/or motor anomalies
(hyposthenia, tremors, dystonia) and/or trophic
changes (skin, nails, hair follicles)
4. Absence of alternative diagnostic interpretation
Id. at 228 (Table I).
In addition, Varenna 2011 teaches that “various studies . . . seem to
demonstrate the efficacy of Bisphosphonates administered intravenously at
high dosages” in treating CRPS. Id. at 233. Among these bisphosphonates,
“the molecule that has most recently demonstrated efficacy is Neridronate
which seems to possess an excellent efficacy profile when administered
intravenously at a dosage of 100 mg per four infusions every fourth day.”
Id.
2. Gatti
Gatti11 reports that “[i]ntravenous high doses of bisphosphonates are
increasingly used for the treatment of reflex sympathetic dystrophy
syndrome or algodystrophy.” Ex. 1008, 1308. According to Gatti, “the
most effective dose is 100 mg diluted in 250 ml of saline solution given
intravenously over 4 days,” and, “[w]ith this treatment regimen, the

11 Gatti originally was written in Italian, but we refer to the English
translation Petitioner submitted.
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proportion of patients experiencing rapid (in 7 – 12 days) > 70%
symptomatic improvements is close to 80%.” Id. Because of these
“preliminary observations,” Gatti reports that “the first formal registrative
randomized double-blind clinical trial comparing 400 mg neridronic acid to
placebo in patients with foot or forearm algodystrophy syndrome has been
designed and is underway.” Id.
3. Muratore
Muratore12 reports the results of a comparison of neridronate and
clodronate “in the treatment of reflex sympathetic hip algodystrophy.”
Ex. 1007, 89. The purpose of the study was “[t]o evaluate the therapeutic
efficacy of Neridronate.” Id. One group of patients in the study “was
administered neridronate 100 mg, intravenously diluted in 250 cc of saline
solution every 4 days 4 times.” Id. Both neridronate and clodronate
“demonstrated being efficacious in the treatment of Reflex Sympathetic
Algodystrophy but the speed of improvement of pain symptoms with
recovery of functional/motor capability . . . was demonstrated to be
statistically more significant in patients treated with Neridronate.” Id.
4. Harden
Harden reports the results of a study that “sought to compare the
relative diagnostic efficiency of [the Budapest Criteria and an alternative,
older set of diagnostic criteria] in discriminating between CRPS and non-
CRPS neuropathic pain patients.” Ex. 1009, 269. The Budapest Criteria are
listed in Harden; they are similar, with minor differences in wording, to the
Budapest Criteria reported in Varenna 2011. Id. at 274 (Appendix II).

12 Muratore originally was written in Italian, but we refer to the English
translation Petitioner submitted.
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Harden teaches that significant numbers of CRPS patients self-reported or
were observed to exhibit allodynia, motor changes, temperature asymmetry,
and sweating asymmetry. Id. at 271 (Table 2). In particular, Harden teaches
that:
• 70.5% of CRPS patients exhibited allodynia on examination;
• 88.3% of CRPS patients self-reported motor changes;
• 79.3% of CRPS patients exhibited motor changes on
examination;
• 86.6% of CRPS patients self-reported temperature asymmetry;
• 69.4% of CRPS patients exhibited temperature asymmetry on
examination;
• 62.5% of CRPS patients self-reported sweating asymmetry; and
• 43.8% of CRPS patients exhibited sweating asymmetry on
examination.
Id.
5. Analysis
Petitioner argues that a person of ordinary skill in the art would have
had reason to combine Harden’s teachings with those of Varenna 2011,
Gatti, and/or Muratore and that those combined teachings teach or suggest
every limitation of claims 1–16. Pet. 24–49.
Patent Owner argues, with respect to claims 1–16, that the evidence of
record does not show that a person of ordinary skill in the art would have
had a reasonable expectation of success in treating complex regional pain
syndrome with neridronic acid. PO Resp. 18–22; PO Sur-Reply 5–14.
Patent Owner also argues that none of the asserted references qualifies as a
printed publication under 35 U.S.C. § 102. PO Resp. 6–18; PO Sur-Reply
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15–22. Finally, with respect to claim 12, Patent Owner argues that none of
the asserted references teach or suggest the duration of symptoms recited in
the claim. PO Resp. 22–25; PO Sur-Reply 14–15.
a. Reasonable Expectation of Success
Patent Owner argues that Petitioner has not shown that a person of
ordinary skill in the art would have had “a reasonable expectation of success
in treating complex regional pain syndrome by administering neridronic
acid.” PO Resp. 19. Specifically, Patent Owner argues that none of
Petitioner’s asserted references provides data showing that administering
neridronic acid improves the symptoms of complex regional pain syndrome
(“CRPS”). Id. at 19–20. Patent Owner also argues that the failure of
Petitioner’s Phase III clinical trials of neridronic acid for treating CRPS
demonstrates the lack of any reasonable expectation of success. Id. at 20–
22. Despite these arguments, we are persuaded that Petitioner has shown by
a preponderance of the evidence the reasonable expectation of success
necessary to support the obviousness of claims 1–16.
As discussed below with respect to claim 1, Petitioner’s position is
that a person of ordinary skill in the art “would have been motivated to
administer neridronic acid to [patients suffering from CRPS] based on the
disclosures of Varenna 2011, Gatti, and/or Muratore, which teach that
neridronic acid is effective for treating CRPS and its symptoms.” Pet. 37.
There is evidence in each of these references that supports a finding that a
person of ordinary skill in the art reasonably would have expected neridronic
acid to treat CRPS successfully. Varenna 2011 describes “Neridronate”13 as

13 “Neridronate” is the salt form of neridronic acid. Ex. 1004 ¶ 43.
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having “recently demonstrated efficacy” and as “seem[ing] to possess an
excellent efficacy profile” in treating CRPS. Ex. 1006, 233. Muratore
describes the treatment of CRPS using “Neridronate” as resulting in faster
“improvement of pain symptoms with recovery of functional/motor
capability, reduction of bone reabsorption markers,” and “statistically more
significant” bone condition restoration, when compared with other drugs.
Ex. 1007, 89. Gatti discloses that a Phase II clinical trial has shown that
neridronic acid used for treating CRPS resulted in “close to 80%” of patients
“experiencing rapid (in 7 – 12 days) > 70% symptomatic improvements.”
Ex. 1008, 1308. Because each of these disclosures suggests successful
treatment of CRPS and its symptoms with neridronic acid, we credit
Dr. Poree’s testimony that a person of ordinary skill in the art “would have
known that neridronate is effective to treat CRPS and its symptoms.”
Ex. 1004 ¶ 38.
Against this evidence, Patent Owner argues first that none of
Petitioner’s asserted references provides data showing that administering
neridronic acid improves the symptoms of CRPS. PO Resp. 19–20. But
“[o]bviousness does not require absolute predictability of success. . . . [A]ll
that is required is a reasonable expectation of success.” In re O’Farrell, 853
F.2d 894, 903–904 (Fed. Cir. 1988). It is sufficient that Varenna 2011,
Gatti, and Muratore taught that successful treatment of CRPS and its
symptoms was likely; there is no requirement that Petitioner show that the
prior art taught that success was certain.
Moreover, even if Petitioner’s references insufficiently demonstrated
that administering neridronic acid resulted in an improvement in the
symptoms of CRPS, it would be immaterial to the question of whether
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Petitioner had shown a reasonable expectation of success. To show the
reasonable expectation of success necessary to prove obviousness, Petitioner
need only show that a person of ordinary skill in the art would have had “a
reasonable expectation of achieving what is claimed in the patent-at-issue.”
Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359,
1367 (Fed. Cir. 2016). Here, the claims at issue recite “[a] method of
treating allodynia associated with complex regional pain syndrome.”
Ex. 1003, 89:27–31. It might be possible to interpret the phrase “treating
allodynia” to require some improvement in the allodynia symptom, but, as
discussed above, this is not the definition the ’338 patent provides. Instead,
as defined in the specification of the ’338 patent, “[a] method of treating
allodynia associated with complex regional pain syndrome” means a method
of diagnosing, curing, mitigating, or preventing allodynia associated with
complex regional pain syndrome, or otherwise affecting the structure or any
function of the body of someone suffering from allodynia associated with
complex regional pain syndrome. The disclosures of Varenna 2011, Gatti,
and Muratore certainly suggest that the administration of neridronic acid to
CRPS patients produced some effect in the structure or function of the
patients’ bodies, including structure and function affected by CRPS. Given
the ’338 patent’s broad definition of “treating,” there is no requirement that
the neridronic acid produce any particular effect, much less achieve any
particular degree of efficacy in improving the symptoms of CRPS.
Patent Owner next argues that the failure of Petitioner’s Phase III
clinical trials of neridronic acid for treating CRPS demonstrates the lack of
any reasonable expectation of success. PO Resp. 20–22. We are not
persuaded by this argument. The record shows that, in 2019, Petitioner
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“decided to discontinue its two ongoing Phase III clinical trials of
Neridronate . . . in patients with Complex Regional Pain Syndrome” because
the “trials were unlikely to meet the primary endpoint.” Ex. 2001, 1–2. At
most, this evidence demonstrates that, in 2019, neridronic acid was known to
be unlikely to achieve some specific result, the primary endpoint of the
trials, when used to treat CRPS. As discussed above, however, there was no
need for the neridronic acid to bring about any particular result; the
challenged claims require the neridronic acid only to produce any effect at
all on the structure or function of a CRPS patient’s body. Thus, the failure
to achieve some specific result weighs little in the reasonable-expectation-
of-success inquiry. In addition, even if the claims of the ’338 patent
required some particular effect, the record contains no explanation of what
the primary endpoint of Petitioner’s Phase III clinical trials was, much less
any evidence that that endpoint was the same effect required by the
challenged claims. For this reason too, the failure of the Phase III clinical
trials to achieve some particular unspecified result is of little value in the
reasonable-expectation-of-success inquiry. In the alternative, even if it were
the case that the failure of the clinical trials to achieve their endpoint was
somehow relevant to the question of whether a person of ordinary skill in the
art reasonably would have expected success, that failure speaks only to what
would have been expected in 2019, years after the invention of the ’338
patent. Bristol-Myers Squibb Co. v. Teva Pharm., Inc., 752 F.3d 967, 976
(Fed. Cir. 2014) (“[T]he skilled artisan’s reasonable expectation of success
is measured ‘as of the date of the invention.’” (quoting Amgen Inc. v.
Hoffman–La Roche, 580 F.3d 1340, 1362 (Fed. Cir. 2009)).
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Thus, the evidence of record shows that, at the time of the invention
of the ’338 patent, a person of ordinary skill in the art reasonably would
have expected to achieve success in achieving what is claimed in the ’338
patent.
b. Printed-Publication Status
Patent Owner argues that none of Petitioner’s asserted references
qualifies as printed publications under 35 U.S.C. § 102. PO Resp. 6–18;
PO Sur-Reply 15–22.
“To qualify as a printed publication, a reference ‘must have been
sufficiently accessible to the public interested in the art.’” Blue Calypso,
LLC v. Groupon, Inc., 815 F.3d 1331, 1348 (Fed. Cir. 2016) (quoting In re
Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989)). “A reference will be
considered publicly accessible if it was disseminated or otherwise made
available to the extent that persons interested and ordinarily skilled in the
subject matter or art exercising reasonable diligence, can locate it.” Id.
(quoting Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340,
1350 (Fed. Cir. 2008)) (internal quotation marks omitted). Thus, there are
two ways to show that a reference was sufficiently accessible: show it was
disseminated, or show it was “otherwise made available to the extent that”
interested people of ordinary skill in the art could have located it after
exercising reasonable diligence. Id.
Here, Petitioner argues that its asserted references “are articles
published in periodical journals by an identified and reputable publisher.”
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Reply 4.14 Accordingly, Petitioner argues that the references were
“disseminated on the[ir] stated publication date[s].” Id. at 6. We agree.
The face of Varenna 2011 notes that it was an “Original Article” that
was “Received on July 15, 2011,” and “Accepted on August 30, 2011.”
Ex. 1006, 227. It also states that the article appeared in the October 2011
publication of “GIOT.” Id. The evidence of record shows that “GIOT”
stands for “Giornale Italiano di Ortopedia e Traumatologia,” which means
“Italian Journal of Orthopedics and Traumatology.” Ex. 1004 ¶ 40;
Ex. 1038, 1. The October 2011 issue of GIOT was disseminated in two
ways, with 150 copies being handed out “at the 96th National Convention of
[the Italian Society of Orthopedics and Traumatology]” on September 26,
2011, and sixty-nine copies being mailed to people on a subscription list.
Ex. 1046.
The face of Gatti notes that it appeared in the journal “Expert Opinion
on Drug Metabolism & Toxicology” in 2009. Ex. 1008, 1305. The
evidence of record shows that the publisher of this journal received,
prepared, and printed this article between May 2009 and September 2009
and that it was made accessible to the public online by September 17, 2009.

14 Patent Owner argues that Petitioner was required to submit any evidence
of the printed-publication status of its asserted references with the Petition
rather than with the Reply. PO Resp. 7. That argument is unpersuasive in
view of the decision in Hulu, LLC v. Sound View Innovations, LLC, which
held that, “if the patent owner challenges a reference’s status as a printed
publication, a petitioner may submit a supporting declaration with its reply
to further support its argument that a reference qualifies as a printed
publication.” IPR2018-01039, Paper 29 at 15 (PTAB Dec. 20, 2019)
(precedential).
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Ex. 1044. Accordingly, we credit the testimony of Dr. Poree that this article
“was published no later than September 2009.” Ex. 1004 ¶ 46.
The face of Muratore notes that it appeared in 2004 in “Progressi in
Reumatologia.” Ex. 1007, 3–4. There is evidence of record that the
National Library of Medicine received Muratore in July 2004. Id. at 3;
Ex. 1043 ¶ 7. Accordingly, we credit the testimony of Dr. Poree that
Muratore was disseminated in 2004. Ex. 1004 ¶ 50.
The face of Harden notes that it was “Received 18 November 2009,”
“Received in revised form 19 March 2010,” and “Accepted 20 April 2010.”
Ex. 1009, 268. It also states that the article appeared in 2010 in “Pain,”
published by the “International Association for the Study of Pain.” Id. In
addition, an article published in 2012 cites Harden among its references,
suggesting that Harden must have been disseminated no later than 2012.
Ex. 1041, 541.
Thus, there is evidence of record that each of the references Petitioner
asserts against claims 1–16 was disseminated publicly before the critical
date, and therefore that each of these references is a prior-art printed
publication. Against this evidence, Patent Owner does not direct us to
contrary evidence, so we find that the preponderance of the evidence
supports a finding that Petitioner’s references are printed publications.
Patent Owner argues that Petitioner failed to show that an interested
person of ordinary skill in the art could have located the asserted references.
PO Resp. 14–17. Patent Owner also argues that some of the asserted
references were not available to a person of ordinary skill in the art because
they were written and published in Italian rather than in English. PO Sur-
Reply 3–4. These arguments ignore Petitioner’s argument that each of the
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asserted references was disseminated publicly, which is sufficient on its own
to prove printed-publication status, without additional proof that a person of
ordinary skill in the art could have located the references. See Blue Calypso,
815 F.3d at 1348 (quoting Kyocera, 545 F.3d at 1350). Moreover, to the
extent that the ability of a person of ordinary skill in the art to locate a
reference is important for publicly disseminated references, skilled artisans
interested in the subject matter could have located the references asserted
here through reasonable diligence. For example, the references Petitioner
asserts were articles in circulation, and a person of ordinary skill in the art
could have reviewed them.
In addition, Patent Owner argues that indicia on the face of a non-
patent reference are never sufficient on their own to prove printed-
publication status. PO Sur-Reply 15–17. As noted above, the evidence of
dissemination of Petitioner’s references comes from the face of the
references,15 from Dr. Poree’s testimony, and from additional evidence
submitted along with Petitioner’s Reply. Accordingly, the question of
whether it might be possible to prove printed-publication status using solely
evidence taken from the face of the reference is irrelevant to our decision
here.
Because the preponderance of the evidence of record shows that
Petitioner’s references were disseminated publicly before the critical date,
we find that the asserted references are printed publications.

15 The evidence on the face of a reference clearly may be considered in
deciding whether the reference is a printed publication. Hulu, IPR2018-
01039, Paper 29 at 17–18 (precedential) (evidence taken from the face of a
reference is to be “considered as part of the totality of the evidence”).
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c. Claim 1
Claim 1 recites “[a] method of treating allodynia associated with
complex regional pain syndrome, comprising parenterally administering
neridronic acid in a salt form or an acid form to a human being suffering
from allodynia associated with complex regional pain syndrome.” Ex. 1003,
89:27–31.
Petitioner argues that a person of ordinary skill in the art “would have
been motivated to administer neridronic acid to [patients suffering from
CRPS] based on the disclosures of Varenna 2011, Gatti, and/or Muratore,
which teach that neridronic acid is effective for treating CRPS and its
symptoms.” Pet. 37. Petitioner argues further that, having been so
motivated, the person of ordinary skill in the art would have “look[ed] to
other references like Varenna 2011 and Harden, which describe the
diagnostic criteria, signs, and symptoms of [CRPS].” Id. Because these
references teach that allodynia is a common symptom of CRPS, Petitioner
argues that the person of ordinary skill in the art “would have had a
reasonable expectation that neridronic acid or one of its salts could
successfully be administered to a patient suffering from allodynia associated
with CRPS.” Id. With the exception of the arguments discussed above with
respect to reasonable expectation of success and printed-publication status,
Patent Owner does not oppose Petitioner’s arguments. PO Resp. 1–27;
PO Sur-Reply 1–26. Patent Owner, however, contends that the use of the
phrase “and/or” in the asserted obviousness grounds results in an
impermissibly vague challenge. PO Resp. 12 n.6; PO Sur-Reply 2–3. For
support, Patent Owner directs us to the Board’s informative decision in
Adaptics Limited v. Perfect Company, Case IPR2018-01596, Paper 20 at 1
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(PTAB Mar. 6, 2019) (informative). The decision in Adaptics is inapposite.
There, the petitioner strung together ten prior art references by the phrase
“and/or,” resulting in no less than “seventeen possible combinations” of
prior art references, and leading to “voluminous and excessive” grounds
nowhere explained adequately by the patent challenger. Adaptics, Paper 20
at 2, 6, 18–19, 21. Here, by contrast, only three prior art references are
combined by the phrase “and/or,” and the combination of references so
combined is identical across both obviousness grounds. Pet. 24, 52.
Further, and most significantly, Petitioner cogently explains the relevant
facts underlying both grounds—facts Patent Owner does not contest. Id. at
24–49, 52–74. Accordingly, we are unpersuaded by Patent Owner’s
argument that the grounds presented here are comparable to those in
Adaptics, or result in an impermissibly vague challenge. PO Resp. 12 n.6;
PO Sur-Reply 2–3.
After considering the entire record, we determine that Petitioner has
shown by a preponderance of the evidence that claim 1 would have been
obvious.
Varenna 2011 teaches that neridronate “seems to possess an excellent
efficacy profile” in treating CRPS. Ex. 1006, 233. In the context of
reporting the use of “[n]eridronic acid for the treatment of bone metabolic
diseases,” Gatti teaches that “[i]ntravenous high doses of bisphosphonates
are increasingly used for the treatment of [CRPS].”16 Ex. 1008, 1305, 1308.

16 Gatti uses the terms “reflex sympathetic dystrophy syndrome” and
“algodystrophy.” Ex. 1008, 1308. On the present record, we interpret both
of these terms as synonymous with “complex regional pain syndrome,”
“CRPS,” “complex regional pain syndrome type I,” “CRPS I,” “reflex
sympathetic algodystrophy,” “reflex sympathetic dystrophy,” and
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Gatti also reports that a clinical trial of neridronic acid “is underway.” Id.
Muratore teaches that neridronate was “efficacious in the treatment of
[CRPS].” Ex. 1007, 89. Thus, on this record, each of these references
sufficiently teaches the efficacy of neridronic acid or its salt in treating
CRPS, suggesting that a person of ordinary skill in the art would have been
motivated to use neridronic acid in treating CRPS.
With respect to the limitation of claim 1 requiring that the neridronic
acid be “parenterally administer[ed],” each of Varenna 2011, Gatti, and
Muratore teaches intravenous administration of neridronic acid. Ex. 1006,
233; Ex. 1007, 89; Ex. 1008, 1308. Intravenous administration is a type of
parenteral administration. Ex. 1004 ¶ 44.
Harden teaches that the Budapest Criteria are used as “clinical
diagnostic criteria for CRPS” and that they include allodynia. Ex. 1009, 274
(Appendix II). Further, Harden teaches that 70.5% of patients diagnosed
with CRPS were observed on examination to exhibit allodynia. Id. at 271
(Table 2). Thus, Harden teaches that a patient with CRPS is likely to suffer
from allodynia. On the present record, because Varenna 2011, Gatti, and
Muratore teach that neridronic acid is effective in treating CRPS, the
combination of any of those references with Harden would have suggested
to a person of ordinary skill in the art that neridronic acid would be effective
in alleviating allodynia associated with CRPS.
Thus, the combination of Harden and one or more of Varenna 2011,
Gatti, and Muratore sufficiently teaches or suggests all the limitations of

“causalgia.” Ex. 1006, 227 (equating “algodystrophy,” “complex regional
pain syndrome type I,” and “CRPS I”); Ex. 1007, 89 (using the term “reflex
sympathetic algodystrophy”); Ex. 1019, 713 (equating “complex regional
pain syndrome,” “CRPS,” “reflex sympathetic dystrophy,” and “causalgia”).
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claim 1. Moreover, Petitioner has shown that a person of ordinary skill in
the art would have had reason to combine the teachings of one or more of
Varenna 2011, Gatti, and Muratore with those of Harden in order to
determine the symptoms of CRPS that could be improved by the treatment.
Ex. 1004 ¶¶ 84–85. Accordingly, we conclude that Petitioner has shown by
a preponderance of the evidence that claim 1 would have been obvious over
the combination of Harden and one or more of Varenna 2011, Gatti, and
Muratore.
d. Claims 2 and 3
Claim 2 of the ’338 patent depends from claim 1 and adds a limitation
requiring that “a total of about 200 mg to about 500 mg of the neridronic
acid [be] administered parenterally to the human being.” Ex. 1003, 89:32–
34. Claim 3 depends from claim 1 and adds a limitation requiring that “a
total of about 400 mg of the neridronic acid [be] administered parenterally to
the human being.” Id. at 89:35–37. Petitioner argues that both Varenna
2011 and Muratore teach these limitations. With the exception of the
arguments discussed above with respect to reasonable expectation of
success, printed-publication status, and impermissible vagueness due to the
use of the phrase “and/or” in the asserted grounds, Patent Owner does not
oppose Petitioner’s arguments. PO Resp. 1–27; PO Sur-Reply 1–26. After
considering the entire record, we determine that Petitioner has shown by a
preponderance of the evidence that claims 2 and 3 would have been obvious.
Muratore teaches administering 100 mg of neridronate per infusion,
with one infusion occurring every four days until four total infusions have
been administered. Ex. 1007, 89. This is a total of 400 mg of neridronate,
which both falls within the recited range of claim 2 and is the specific
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amount recited in claim 3. Thus, Petitioner has shown by a preponderance
of the evidence that the combination of Harden and at least one of Varenna
2011, Gatti, and Muratore teaches or suggests the limitations of claims 2
and 3.
e. Claim 4
Claim 4 depends from claim 1 and adds a limitation requiring that “a
total of about 100 mg to about 200 mg of the neridronic acid [be]
administered parenterally to the human being within a period of about 1
month.” Ex. 1003, 89:38–41. Petitioner argues that Gatti teaches this
limitation. With the exception of the arguments discussed above with
respect to reasonable expectation of success, printed-publication status, and
impermissible vagueness due to the use of the phrase “and/or” in the
asserted grounds, Patent Owner does not oppose Petitioner’s arguments. PO
Resp. 1–27; PO Sur-Reply 1–26. After considering the entire record, we
determine that Petitioner has shown by a preponderance of the evidence that
claim 4 would have been obvious.
Gatti teaches that “the most effective dose is 100 mg diluted in 250 ml
of saline solution given intravenously over 4 days.” Ex. 1008, 1308. This
statement in Gatti may refer to “bisphosphonates” generally, rather than to
neridronic acid specifically, because the paragraph in which this statement
appears begins with a reference to “high doses of bisphosphonates.” Id. The
following paragraph, however, states that, because of the efficacy of the
specified dose, a clinical trial of neridronic acid “is underway.” Id. This
suggests that the specific bisphosphonate for which “the most effective dose
is 100 mg diluted in 250 ml of saline solution given intravenously over 4
days” is neridronic acid. Id. Moreover, the entirety of Gatti discusses
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“[n]eridronic acid for the treatment of bone metabolic diseases,” which also
suggests that the particular bisphosphonate in question is neridronic acid. Id.
at 1305. Thus, in this manner, Gatti teaches or suggests the administration
of 100 mg of neridronic acid.17 Accordingly, Petitioner has shown by a
preponderance of the evidence that the combination of Harden and at least
one of Varenna 2011, Gatti, and Muratore teaches or suggests the limitations
of claim 4.
f. Claim 5
Claim 5 depends from claim 1 and adds a limitation requiring that “a
total of about 250 mg of the neridronic acid [be] administered parenterally to
the human being within a period of about 1 month.” Ex. 1003, 89:42–44.
Petitioner argues that the claimed dose falls within the range of doses that
the prior art describes as effective and that a person of ordinary skill in the
art would have been motivated and able to arrive at the optimum dose of
neridronic acid. Pet. 39–41. With the exception of the arguments discussed
above with respect to reasonable expectation of success, printed-publication
status, and impermissible vagueness due to the use of the phrase “and/or” in
the asserted grounds, Patent Owner does not oppose Petitioner’s arguments.
PO Resp. 1–27; PO Sur-Reply 1–26. After considering the entire record, we
determine that Petitioner has shown by a preponderance of the evidence that
claim 5 would have been obvious.
Gatti teaches that a dose of 100 mg of neridronic acid is effective in
treating CRPS. Ex. 1008, 1308 (this dose reduces symptoms of CRPS by

17 Gatti likewise also suggests administration of 100 mg of neridronic acid
by teaching (1) the administration of 100 mg of bisphosphonates and (2) that
neridronic acid is an exemplary bisphosphonate. Ex. 1008, 1308.
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more than 70% in “close to 80%” of patients). Muratore teaches that a dose
of 400 mg of neridronate is effective in treating CRPS. Ex. 1007, 89
(improvement in several symptoms occurred faster with this dose of
neridronate than in groups treated with other drugs). The 250 mg dose of
claim 5 falls between these two prior-art values, and there is evidence of
record that a person of ordinary skill in the art would have been motivated
and able to find an optimum dose of neridronic acid within the prior-art
range. Ex. 1004 ¶¶ 102–103. Given this, “it is not inventive to discover the
optimum or workable ranges by routine experimentation.” In re Aller, 220
F.2d 454, 456 (CCPA 1955). Accordingly, Petitioner has shown by a
preponderance of the evidence that the combination of Harden and at least
one of Varenna 2011, Gatti, and Muratore teaches or suggests the limitations
of claim 5.
g. Claims 6 and 7
Claim 6 depends from claim 2 and adds a limitation requiring that
“the neridronic acid [be] administered in divided parenteral doses.”
Ex. 1003, 89:45–46. Claim 7 depends from claim 6 and adds a limitation
requiring that “each divided parenteral dose contain[] about 10 mg to about
150 mg of the neridronic acid.” Id. at 89:47–49. Petitioner argues that both
Varenna 2011 and Muratore teach these limitations. With the exception of
the arguments discussed above with respect to reasonable expectation of
success, printed-publication status, and impermissible vagueness due to the
use of the phrase “and/or” in the asserted grounds, Patent Owner does not
oppose Petitioner’s arguments. PO Resp. 1–27; PO Sur-Reply 1–26. After
considering the entire record, we determine that Petitioner has shown by a
preponderance of the evidence that claims 6 and 7 would have been obvious.
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Varenna 2011 teaches a divided parenteral dose in which each
division falls between 10 mg and 150 mg of neridronate. Ex. 1006, 233
(teaching that neridronate is “administered intravenously at a dosage of 100
mg per four infusions every fourth day”). This clearly teaches dividing a
total dose into “four infusions.” Id. Regardless of whether the total dose is
100 mg, as is apparent from the text of Varenna 2011, or 400 mg, as
Petitioner argues, the division into four infusions means that each infusion
contains an amount of neridronate between 10 mg and 150 mg.
Similarly, Muratore teaches administering 100 mg of neridronate per
infusion, with one infusion occurring every four days until four total
infusions have been administered. Ex. 1007, 89. This clearly teaches
dividing a total dose of 400 mg into four infusions. Id. Thus, Muratore
teaches both the limitation of claim 6 and, because the divided doses contain
100 mg each, the limitation of claim 7.
Accordingly, Petitioner has shown by a preponderance of the evidence
that the combination of Harden and at least one of Varenna 2011, Gatti, and
Muratore teaches or suggests the limitations of claims 6 and 7.
h. Claim 8
Claim 8 depends from claim 6 and adds a limitation requiring that
“each divided parenteral dose contain[] about 62 mg to about 63 mg of the
neridronic acid.” Id. at 89:50–52. Petitioner argues that the claimed dose
falls within the range of doses that the prior art describes as effective and
that a person of ordinary skill in the art would have been motivated and able
to arrive at the optimum dose of neridronic acid. Pet. 42–44. With the
exception of the arguments discussed above with respect to reasonable
expectation of success, printed-publication status, and impermissible
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vagueness due to the use of the phrase “and/or” in the asserted grounds,
Patent Owner does not oppose Petitioner’s arguments. PO Resp. 1–27;
PO Sur-Reply 1–26. After considering the entire record, we determine that
Petitioner has shown by a preponderance of the evidence that claim 8 would
have been obvious.
There is evidence of record that a person of ordinary skill in the art
would have been motivated and able to find an optimum dose of neridronic
acid. Ex. 1004 ¶¶ 102–105, 110–111. Given this, “it is not inventive to
discover the optimum or workable ranges by routine experimentation.”
Aller, 220 F.2d at 456. Accordingly, Petitioner has shown by a
preponderance of the evidence that the combination of Harden and at least
one of Varenna 2011, Gatti, and Muratore teaches or suggests the limitations
of claim 8.
i. Claim 9
Claim 9 depends from claim 1 and adds a limitation requiring that
“the complex regional pain syndrome [be] associated with an inciting
traumatic event.” Ex. 1003, 89:53–55. Petitioner argues that both Harden
and Varenna 2011 teach this limitation. Pet. 44–45. With the exception of
the arguments discussed above with respect to reasonable expectation of
success, printed-publication status, and impermissible vagueness due to the
use of the phrase “and/or” in the asserted grounds, Patent Owner does not
oppose Petitioner’s arguments. PO Resp. 1–27; PO Sur-Reply 1–26. After
considering the entire record, we determine that Petitioner has shown by a
preponderance of the evidence that claim 9 would have been obvious.
Varenna 2011 teaches that “approximately half the cases [of CRPS]
(from 40 to 65%) recognize[] trauma as the triggering event.” Ex. 1006,
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229. Harden teaches that traumatic events caused 73.6% of CRPS cases,
with fractures accounting for 41.6% of cases and surgery and crush injuries
causing another 32%. Ex. 1009, 269. Thus, a person of ordinary skill in the
art would have expected most cases of CRPS to have resulted from a
traumatic triggering event. Because, as discussed above, Petitioner has
shown by a preponderance of the evidence that a person of ordinary skill in
the art would have expected neridronic acid to alleviate allodynia associated
with CRPS, that person would have been motivated to do so in the majority
of CRPS cases resulting from a traumatic initiating event. Ex. 1004 ¶¶ 113–
115. Accordingly, Petitioner has shown by a preponderance of the evidence
that the combination of Harden and at least one of Varenna 2011, Gatti, and
Muratore teaches or suggests the limitations of claim 9.
j. Claims 10 and 11
Claim 10 depends from claim 1 and adds a limitation requiring that
“the human being has suffered from complex regional pain syndrome for at
least 6 months.” Ex. 1003, 89:56–58. Claim 11 depends from claim 1 and
adds a limitation requiring that “the human being has suffered from complex
regional pain syndrome for about 6 months to about 12 months.” Id. at
89:59–61. Petitioner argues that these limitations would have been obvious
to a person of ordinary skill in the art. Pet. 45–46. With the exception of the
arguments discussed above with respect to reasonable expectation of
success, printed-publication status, and impermissible vagueness due to the
use of the phrase “and/or” in the asserted grounds, Patent Owner does not
oppose Petitioner’s arguments. PO Resp. 1–27; PO Sur-Reply 1–26. After
considering the entire record, we determine that Petitioner has shown by a
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preponderance of the evidence that claims 10 and 11 would have been
obvious.
The average duration of CRPS symptoms in the study reported in
Muratore was 4.1 months, with some patients having suffered from CRPS
for at least 6.1 months. Ex. 1007, 89. The disease duration of 6.1 months in
Muratore falls within the range recited in claim 10 (“at least 6 months”) and
claim 11 (“about 6 months to about 12 months”). Ex. 1003, 89:56–61. The
ranges of disease duration recited in claims 10 and 11 fall within the range
of 4.1 months to ten years disclosed in the prior art. Accordingly, Petitioner
has shown by a preponderance of the evidence that the combination of
Harden and at least one of Varenna 2011, Gatti, and Muratore teaches or
suggests the limitations of claims 10 and 11.
k. Claim 12
Claim 12 depends from claim 1 and adds a limitation requiring that
“the human being has suffered from complex regional pain syndrome for
about 1 year to about 2 years.” Ex. 1003, 90:1–3. Petitioner argues that this
limitation would have been obvious to a person of ordinary skill in the art.
Pet. 45–46; Reply 21–23. In particular, Petitioner argues that it would have
been obvious to treat patients who had suffered for between one year and
two years because Muratore taught treating patients who had suffered for
more than six months and other art taught that CRPS could last for longer
than one year. Reply 21–23. Patent Owner disagrees, arguing that none of
the asserted references teaches using neridronic acid to treat a patient who
has suffered from CRPS for between one year and two years. PO Resp. 22–
25; PO Sur-Reply 14–15. Patent Owner also argues that Petitioner has
shown at most that a person of ordinary skill in the art could have treated
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patients who had suffered from CRPS for between one year and two years,
not that they would have had a reason to do so. PO Sur-Reply 15. After
considering the entire record, we determine that Petitioner has shown by a
preponderance of the evidence that claim 12 would have been obvious.
As discussed above with respect to claims 10 and 11, Muratore
teaches treating patients who have suffered from CRPS for up to 6.1 months.
Ex. 1007, 89. Varenna 2011 teaches that symptoms of CRPS often last for
“ten years from the onset of the disease.” Ex. 1006, 230. Accordingly, we
credit the testimony of Dr. Poree that a person of ordinary skill in the art
“would have reasonably expected that neridronate could be used to
successfully treat symptoms of CRPS . . . in patients having CRPS for up to
and including 2 years.” Ex. 1004 ¶ 118. We note that we have not been
directed to record evidence that a person of ordinary skill in the art would
have considered it more difficult to treat patients who had suffered CRPS
symptoms for between one year and two years than to treat those who had
suffered for shorter periods. Given the disclosures of Muratore and Varenna
2011, as well as the testimony of Dr. Poree, we determine that a person of
ordinary skill in the art would have found it obvious to treat patients who
had suffered for between one year and two years using the same treatment
used to treat those who had suffered for over six months. Thus, Petitioner
has shown by a preponderance of the evidence that the combination of
Harden and at least one of Varenna 2011, Gatti, and Muratore teaches or
suggests the limitations of claim 12.
l. Claim 13
Claim 13 depends from claim 1 and adds a limitation requiring that
“the human being ha[ve] an age of about 30 years to about 40 years.”
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Ex. 1003, 90:4–5. Petitioner argues that Muratore teaches this limitation.
Pet. 47. With the exception of the arguments discussed above with respect
to reasonable expectation of success, printed-publication status, and
impermissible vagueness due to the use of the phrase “and/or” in the
asserted grounds, Patent Owner does not oppose Petitioner’s arguments. PO
Resp. 1–27; PO Sur-Reply 1–26. After considering the entire record, we
determine that Petitioner has shown by a preponderance of the evidence that
claim 13 would have been obvious.
Muratore reports the results of a study in which at least one CRPS
patient was 39 years old. Ex. 1007, 89 (disclosing that female patients
ranged in age from 39 to 57). This falls within the range recited in claim 13.
Accordingly, Petitioner has shown by a preponderance of the evidence that
the combination of Harden and at least one of Varenna 2011, Gatti, and
Muratore teaches or suggests the limitations of claim 13.
m. Claims 14–16
Claim 14 depends from claim 1 and adds a limitation requiring that
“the human being ha[ve] a pain intensity of at least 7 cm on the 10 cm visual
analogue scale (VAS) or at least 7 on the 0-10 numeric rating scale (NRS).”
Ex. 1003, 90:6–9. Claim 15 depends from claim 1 and adds a limitation
requiring that “the human being ha[ve] a pain intensity of at least 8cm [sic]
on the 10 cm VAS or at least 8 on the 0-10 NRS.” Id. at 90:10–12.
Claim 16 depends from claim 1 and adds a limitation requiring that “the
human being ha[ve] a pain intensity of at least 9 cm on the 10 cm VAS or at
least 9 on the 0-10 NRS.” Id. at 90:13–15. Petitioner argues that these
limitations would have been obvious to a person of ordinary skill in the art.
Pet. 48–49. With the exception of the arguments discussed above with
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respect to reasonable expectation of success, printed-publication status, and
impermissible vagueness due to the use of the phrase “and/or” in the
asserted grounds, Patent Owner does not oppose Petitioner’s arguments. PO
Resp. 1–27; PO Sur-Reply 1–26. After considering the entire record, we
determine that Petitioner has shown by a preponderance of the evidence that
claims 14–16 would have been obvious.
The Budapest Criteria for diagnosing CRPS include “[c]ontinuous
pain disproportionate to the triggering event.” Ex. 1006, 228 (Table I); see
Ex. 1009, 274 (Appendix II). As discussed above, the events that can trigger
CRPS are most often traumatic in nature, including fractures, surgery, and
crush injuries. Ex. 1009, 269. Accordingly, “CRPS is characterized and
defined by severe and continuing pain.” Ex. 1004 ¶ 127. There is evidence
of record that “‘severe’ pain includes patients with high VAS scores, such as
≥7 cm.” Id. As discussed above, the combination of Harden and at least one
of Varenna 2011, Gatti, and Muratore teaches or suggests treating CRPS
with neridronic acid. Thus, the evidence of record shows that a person of
ordinary skill in the art “would reasonably [have] expect[ed] that neridronic
acid could be successfully used to treat . . . CRPS in patients having VAS
scores ≥7 cm, 8 cm, or 9 cm.” Id. Accordingly, Petitioner has shown by a
preponderance of the evidence that the combination of Harden and at least
one of Varenna 2011, Gatti, and Muratore teaches or suggests the limitations
of claims 14–16.
D. Asserted Indefiniteness of Claims 17–30
Petitioner argues that claims 17–30 of the ’338 patent are indefinite
because a person of ordinary skill in the art “would not have understood
what ‘autonomic motor change’ associated with CRPS refers to.” Pet. 50–
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52. Patent Owner disagrees, arguing that a person of ordinary skill in the art
“would have known that ‘autonomic motor changes’ refer[red] to changes in
the ‘autonomic motor system.’” PO Resp. 25–26.
There are two standards that may be used to determine whether claims
challenged in a post-grant review are indefinite. See Tinnus Enterprises,
LLC v. Telebrands Corp., 733 F. App’x 1011, 1016–18 (Fed. Cir. 2018)
(declining to decide whether post-grant review proceedings should use the
pre-issuance indefiniteness test of In re Packard, 751 F.3d 1307 (Fed. Cir.
2014), or the post-issuance indefiniteness standard of Nautilus, Inc. v. Biosig
Instruments, Inc., 134 S. Ct. 2120 (2014)). Both parties here base their
arguments on the Nautilus standard. Pet. 50 (expressly relying on Nautilus
standard); PO Resp. 26 (arguing that “[t]he language of [the challenged
claims] would have informed a [person of ordinary skill in the art] about the
scope of the invention with reasonable certainty,” the standard set forth in
Nautilus). We need not decide which standard to apply, however, because
Petitioner fails to carry its burden under either standard.
Under the Nautilus standard, a claim is indefinite under 35 U.S.C.
§ 112 if it fails to “inform those skilled in the art about the scope of the
invention with reasonable certainty.” Nautilus, 134 S. Ct. at 2129. Here,
Petitioner argues that a person of ordinary skill in the art “would not have
understood what ‘autonomic motor change’ associated with CRPS refers to,”
rendering the scope of claims 17–30 indefinite. Pet. 50–52; Reply 23–24.
As discussed above, however, on the record developed during trial, we find
that a person of ordinary skill in the art would have understood the meaning
of “autonomic motor change.” Specifically, we conclude that a person of
ordinary skill in the art would have understood this phrase to mean “changes
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in the autonomic motor system, such as changes in skin blood flow, changes
in temperature, such as temperature asymmetry, and sweating changes.”
Accordingly, we are not persuaded that Petitioner has shown by a
preponderance of the evidence that a person of ordinary skill in the art would
have been unable to understand the term “autonomic motor change” or that
such a lack of understanding would have led that person to be uninformed to
a reasonable certainty about the scope of claims 17–30.
Petitioner’s argument fails under Packard as well. Under Packard, a
claim is indefinite if it “contains words or phrases whose meaning is
unclear.” 751 F.3d at 1309–10. Here, Petitioner does not offer any
argument that claims 17–30 fail to meet this standard. Pet. 50–52; Reply
23–24. We note that Petitioner’s argument that a person of ordinary skill in
the art “would not have understood what ‘autonomic motor change’
associated with CRPS refers to,” Pet. 50–52, might reasonably be construed
as an argument that the meaning of the phrase “autonomic motor change” is
unclear. Even if Petitioner had made such an argument, however, we would
find it unpersuasive. As discussed above, the meaning of “autonomic motor
change” on this record is sufficiently clear: it means “changes in the
autonomic motor system, such as changes in skin blood flow, changes in
temperature, such as temperature asymmetry, and sweating changes.”
Accordingly, we are not persuaded that Petitioner has shown by a
preponderance of the evidence that claims 17–30 contain words or phrases
whose meaning is unclear.
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E. Asserted Obviousness over Harden, Drummond, and One or More
of Varenna 2011, Gatti, and Muratore
Petitioner argues that claims 17–30 of the ’338 patent would have
been obvious over the combination of Harden, Drummond, and one or more
of Varenna 2011, Gatti, and Muratore. Pet. 52–74.
1. Drummond
Drummond reports a review of “mechanisms that might contribute to
sensory disturbances and sympathetically-maintained pain in complex
regional pain syndrome (CRPS).” Ex. 1010, 1257. In the course of this
review, Drummond teaches that “CRPS is associated with a range of . . .
autonomic abnormalities.” Id. According to Drummond, these
“[a]utonomic disturbances . . . range from signs of sympathetic deficit
(warmth and loss of vasoconstrictor reflexes) to sympathetic overactivity
(sweating and coldness).” Id. at 1260. This effect can “spread beyond the
CRPS-affected limb.” Id.
2. Analysis
a. Reasonable Expectation of Success
As it does with respect to the ground of obviousness challenging
claims 1–16, Patent Owner argues that Petitioner fails to show the
obviousness of claims 17–30 because it fails to show that a person of
ordinary skill in the art would have had “a reasonable expectation of success
in treating complex regional pain syndrome by administering neridronic
acid.” PO Resp. 26. We disagree with this argument for the same reasons
discussed above.
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b. Printed-Publication Status
As discussed above, despite Patent Owner’s arguments to the
contrary, Petitioner has shown by a preponderance of the evidence that
Varenna 2011, Gatti, Muratore, and Harden qualify as printed publications.
In opposing Petitioner’s argument that claims 17–30 are obvious, Patent
Owner raises the same argument with respect to Drummond. PO Resp. 6–
18; PO Sur-Reply 15–22.
The face of Drummond notes that it appeared in the journal “Pain
Medicine,” published by “Wiley Periodicals, Inc.” in 2010. Ex. 1010, 1257.
Other articles published in the same journal at around the same time appear
in the prosecution history of the ’338 patent. Ex. 1037, 192 (September
2004 publication by Robinson), 216 (September 2016 publication by
Varenna), 231 (August 2010 publication by Coderre). This strongly
suggests that articles published in Pain Medicine, including Drummond,
were disseminated publicly. Against this evidence supporting dissemination
of Drummond, Patent Owner does not direct us to contrary evidence, so we
find that the preponderance of the evidence supports a finding that
Drummond qualifies as a printed publication.
c. Claim 17
Claim 17 recites “[a] method of treating autonomic motor change
associated with complex regional pain syndrome, comprising administering
neridronic acid in a salt form or an acid form to a human being suffering
from autonomic motor change associated with complex regional pain
syndrome.” Ex. 1003, 90:17–21. As discussed above, we construe
“autonomic motor change” as “changes in the autonomic motor system, such
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as changes in skin blood flow, changes in temperature, such as temperature
asymmetry, and sweating changes.”
Petitioner argues that a person of ordinary skill in the art “would have
been motivated to administer neridronic acid to [patients suffering from
CRPS] based on the disclosures of Varenna 2011, Gatti, and/or Muratore,
which teach that neridronic acid is effective for treating CRPS and its
symptoms.” Pet. 61. Petitioner argues further that, having been so
motivated, the person of ordinary skill in the art would have “look[ed] to
other references like Varenna 2011 and Harden, which describe the
diagnostic criteria, signs, and symptoms of [CRPS].” Id. at 62. Because
Varenna 2011, Harden, and Drummond all teach that autonomic or motor
changes are common symptoms of CRPS, Petitioner argues that the person
of ordinary skill in the art “would have had a reasonable expectation that
neridronic acid or one of its salts could successfully be administered to a
patient suffering from autonomic and/or motor changes associated with
CRPS.” Id. at 61. With the exception of the arguments discussed above
with respect to reasonable expectation of success, printed-publication status,
and impermissible vagueness due to the use of the phrase “and/or” in the
asserted grounds, Patent Owner does not oppose Petitioner’s arguments. PO
Resp. 1–27; PO Sur-Reply 1–26. After considering the entire record, we
determine that Petitioner has shown by a preponderance of the evidence that
claim 17 would have been obvious.
Petitioner is correct that a person of ordinary skill in the art would
have been motivated to administer neridronic acid to treat CRPS. As
discussed above with respect to claims 1–16, each of Varenna 2011, Gatti,
and Muratore teaches the efficacy of neridronic acid or its salt in treating
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CRPS, suggesting that a person of ordinary skill in the art would have been
motivated to use neridronic acid in treating CRPS. Ex. 1006, 233; Ex. 1007,
89; Ex. 1008, 1305, 1308. In addition, each of these references teaches
intravenous administration of neridronic acid. Ex. 1004 ¶ 42; Ex. 1006, 233;
Ex. 1007, 89; Ex. 1008, 1308.
As for the person of ordinary skill in the art understanding that the
symptoms of CRPS included autonomic motor change, Petitioner bases its
arguments on a proposed construction of “autonomic motor change” as
“includ[ing] autonomic dysfunction associated with CRPS, motor changes
associated with CRPS, or both.” Id. at 52. Petitioner further defines
“autonomic dysfunction” as including “changes in skin temperature and
sweating.” Id. at 53. We note that the exemplary symptoms of “autonomic
dysfunction” identified by Petitioner fall within our construction of
“autonomic motor change” as “changes in the autonomic motor system, such
as changes in skin blood flow, changes in temperature, such as temperature
asymmetry, and sweating changes.”
Harden teaches that the Budapest Criteria are used as “clinical
diagnostic criteria for CRPS” and include temperature and sweating
asymmetries. Ex. 1009, 274 (Appendix II); Ex. 1004 ¶ 78. Similarly, the
listing of the Budapest Criteria in Varenna 2011 describes the symptoms of
CRPS as including both “asymmetry of warmth when touched” and
“perspiration anomalies and/or asymmetry.” Ex. 1006, 228. Further,
Harden teaches that a patient with CRPS is likely to suffer from temperature
asymmetry or sweating asymmetry. Ex. 1009, 271 (Table 2) (reporting that
86.6% of CRPS patients reported “[t]emperature asymmetry,” that 69.4% of
CRPS patients were observed to have “[t]emperature asymmetry,” that
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62.5% of CRPS patients self-reported “[s]weating asymmetry,” and that
43.8% of CRPS patients were observed to have “[s]weating asymmetry”).
Because Varenna 2011, Gatti, and Muratore teach that neridronic acid is
effective in treating CRPS, the combination of any of those references with
Harden18 would have suggested to a person of ordinary skill in the art that
neridronic acid would be effective in alleviating autonomic motor change
associated with CRPS.
Thus, the combination of Harden and one or more of Varenna 2011,
Gatti, and Muratore teaches or suggests all the limitations of claim 17.
Moreover, Petitioner has shown sufficiently that a person of ordinary skill in
the art would have had reason to combine the teachings of one or more of
Varenna 2011, Gatti, and Muratore with those of Harden in order to
determine the symptoms of CRPS that could be improved by the treatment.
Ex. 1004 ¶¶ 84–85. Accordingly, we conclude that Petitioner has shown by
a preponderance of the evidence that claim 17 would have been obvious
over the combination of Harden and one or more of Varenna 2011, Gatti,
and Muratore.

18 Petitioner argues that Drummond also teaches that CRPS patients may
suffer from autonomic motor change. Pet. 56–57. As discussed below,
Patent Owner has moved to exclude the evidence of Drummond’s status as
prior art. We need not resolve the issue of whether that evidence should be
excluded, however, because, even without the teachings of Drummond,
Petitioner has shown by a preponderance of the evidence that a person of
ordinary skill in the art would have understood that CRPS included
symptoms of autonomic motor change. Accordingly, we do not consider the
teachings of Drummond in evaluating this obviousness ground.
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d. Claims 18–30
Other than their dependency from claim 17 rather than from claim 1,
claims 18–29 of the ’338 patent are identical to claims 2–13, and claim 30 is
identical to claim 15. Compare Ex. 1003, 89:27–90:16, with Ex. 1003,
90:17–60. Accordingly, for the same reasons as discussed above with
respect to claims 2–16, we conclude that Petitioner has shown by a
preponderance of the evidence that claims 18–30 would have been obvious
over the combination of Harden and one or more of Varenna 2011, Gatti,
and Muratore.
F. Asserted Lack of Written Description
Petitioner asserts that claims 1–30 lack written description support in
“[t]he ’338 patent specification.”19 Pet. 75; see Pet. 9 (grounds chart). In
our Decision on Institution, we concluded that Petitioner had not shown a
reasonable likelihood of prevailing on this asserted ground of
unpatentability. Dec. Inst. 29–34. After we made that determination,
neither party addressed this ground any further. PO Resp. 1–27; Reply 1–
25; PO Sur-Reply 1–26. Accordingly, the record after trial remains the same
as it was at the time we instituted review, and we repeat our original analysis
here, which remains applicable to our consideration of the record after trial.

19 The relevant inquiry is whether the subject matter of the challenged
claims finds written description support “in the originally filed disclosure.”
Purdue Pharm. L.P. v. Faulding Inc., 230 F.3d 1320, 1326–27 (Fed. Cir.
2000). We adopt Petitioner’s convention of referring to the ’338 patent
specification, rather than Application No. 15/820,305, which matured to
issue as the ’338 patent. See Pet. 75–78 (repeatedly referring to, and citing,
the ’338 patent specification); Ex. 1003, code (21) (identification of
Application No. 15/820,305).
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“[T]he hallmark of written description is disclosure.” Ariad Pharms.,
Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A
patent disclosure is sufficient if it “reasonably conveys to those skilled in the
art that the inventor had possession of the claimed subject matter as of the
filing date,” based on an “objective inquiry into the four corners of the
specification.” Id. Petitioner argues that the ’338 patent specification “does
not specifically describe administration of neridronic acid to human beings
to treat allodynia” (claims 1–16) or “autonomic and/or motor change”
(claims 17–30) associated with CRPS. Pet. 76, 77.
We find Petitioner’s information on this point insufficient for two
independent reasons. First, the original claims set forth in the patent
application that matured to issue as the ’338 patent are part of the disclosure
that we consider when assessing the question of compliance with the written
description requirement. See Ex. 1037, 129–130 (prosecution history,
claims as originally filed). It is well settled that “original claims constitute
their own description.” In re Koller, 613 F.2d 819, 823 (CCPA 1980); see
In re Gardner, 475 F.2d 1389, 1391 (CCPA 1973) (“[A]n original claim, in
itself constituted a description in the original disclosure equivalent in scope
and identical in language to the total subject matter now being claimed.”).
Claim 1, as issued, contains only a slight wording change from claim 1 as
originally filed. Compare Ex. 1037, 129 (claim 1), with Ex. 1003, 89:27–31
(changing “. . . in a salt or an acid form . . .” to “. . . in a salt form or an acid
form . . .”). Claim 17, as issued, is identical to claim 17 as originally filed.
Compare Ex. 1037, 130 (claim 17), with Ex. 1003, 90:17–21. That
circumstance, on this record, lays to rest any question that independent
claim 1 or 17 lacks written description support.
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Petitioner raises no argument specific to any limitation of a dependent
claim. Pet. 69–72. In any event, a straightforward comparison of original
claims 1–30 to claims 1–30, as issued, reveals that they are essentially
identical. Compare Ex. 1035, 129–131 (original claims 1–30), with
Ex. 1003, 89:27–90:60 (revealing that, in addition to the slight word change
to claim 1, original claim 14 was modified to spell out the meaning of two
acronyms—“VAS” and “NRS”—in the claim as issued, and claims 7 and 8
had small changes to remove the redundant text “division of the”). On this
record, therefore, the original claims represent “a description in the original
disclosure equivalent in scope” to the subject matter of the challenged
claims. In re Gardner, 475 F.2d at 1391. “Nothing more is necessary for
compliance with the description requirement of the first paragraph of
35 U.S.C. § 112.”20 Id.
Second, we find insufficient Petitioner’s argument that “the ’338
patent specification,” and, in particular, Examples 1–3, “do not specifically
describe administration of neridronic acid to human beings” for the purpose
of treating “allodynia” or “autonomic and/or motor change” associated with
CRPS. Pet. 76 (for “allodynia”), 77 (for “autonomic and/or motor change”).
Petitioner, in that regard, argues that the rat tibia fracture model discussed in

20 We do not mean to suggest that original claims always and inevitably
provide their own written-description support. When a claim recites a genus
and “use[s] functional language to define the boundaries of [the] claimed
genus,” it “may simply claim a desired result, and may do so without
describing species that achieve that result.” Ariad, 598 F.3d at 1349. When
this is the case, “the specification must demonstrate that the applicant has
made a generic invention that achieves the claimed result and do so by
showing that the applicant has invented species sufficient to support a claim
to the functionally-defined genus.” Id. Petitioner has not alleged, however,
that the claims of the ’338 patent raise the issue described in Ariad.
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those examples, which involved administration of zoledronic acid to rats,
does not support the claimed feature that requires administration of a
different bisphosphonate (neridronic acid) to treat a different animal (a
human being). Id. at 76–78. Petitioner focuses on those examples in
isolation, without adequately accounting for the disclosure of the
specification as a whole.
The specification expressly contemplates the use of neridronic acid to
treat CRPS, and contains disclosure adequate to indicate possession of a
method of intravenous administration of neridronic acid to treat allodynia,
autonomic change, and motor change in human patients. See, e.g., Ex. 1003,
3:19–24 (for allodynia), Fig. 3, 13:23–26, 51:29–31, 52:44–45, 61:59–62
(for autonomic or motor change). The specification expressly lists
neridronic acid alongside zoledronic acid when identifying bisphosphonate
compounds that are suitable for use in the invention—and does so,
moreover, specifically in the context of reversing “allodynia.” Id. at 3:19–
24. As explained above (supra 5), the specification not only mentions
neridronic acid alongside zoledronic acid when describing the
bisphosphonate compounds useful in the invention, but does so in the
context of describing the administration of a bisphosphonate to a human
being suffering from CRPS. Ex. 1003, 3:13–24, 8:37–47. Those
disclosures, on this record, suggest that the two bisphosphonates behave
similarly in the claimed invention. Id. Further, the specification repeatedly
and consistently indicates that the inventors were in possession of a
treatment applicable to a “human,” “human being” or “human patient.” Id.
at 2:22, 2:46, 7:24, 8:40, 9:20, 9:29, 9:33, 13:65, 14:4, 14:11, 23:31, 23:44,
24:16, 31:5, 36:59, 37:54, 38:45, 39:33, 39:39, 39:44.
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Although Examples 1–3 contain data keyed to the efficacy of
zoledronic acid in a rat tibia fracture model (in which CRPS was induced
and evaluated in non-human animals), that fact does not end the inquiry. Id.
at 49:15–52:50 (Examples 1–3, describing the efficacy of zoledronic acid in
rat tibia fracture model of CRPS). Each of those examples includes
disclosure that explains how to extrapolate starting dosages for animals to
dosages appropriate for human patients, by reference to FDA guidelines. Id.
at 49:31–37, 50:11–13 (Example 1), 51:2–6 (Example 2), 52:46–50
(Example 3).
Example 3 goes further, citing prior research demonstrating that the
rat tibia fracture model, referenced in the working examples, replicates
CRPS as “observed in human CRPS patients.” Id. at 51:13–23 (Example 3,
citing a prior publication). Moreover, “Embodiment 79” expressly refers to
“[a] method of treating complex regional pain syndrome, comprising
administering neridronic acid to a human being in need thereof.” Id. at
67:38–40.
In sum, on the present record, we find that the claims as originally
filed provide written-description support for the claims as issued in the ’338
patent. Compare Ex. 1037, 129–130 (claims 1–30, as originally filed), with
Ex. 1003, 89:27–90:60 (claims as issued). But even if we set aside that
circumstance, other disclosures, discussed above, provide intrinsic support
for the claims—support that is addressed inadequately, if at all, by Petitioner
and Dr. Poree. Pet. 75–78 (including citations to Ex. 1004). Accordingly,
we find that Petitioner fails to show by a preponderance of the evidence that
any challenged claim is unpatentable for lack of written-description support.
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G. Motions to Exclude
Patent Owner’s motion to exclude evidence seeks to exclude all or
parts of Exhibits 1004, 1006–1010, 1038, 1040, and 1043–1046. Mot.
Exclude 1–15. We consider the arguments for each exhibit separately.
1. Exhibit 1004: Declaration of Dr. Poree
Patent Owner moves to exclude any portion of Dr. Poree’s declaration
that relies on Exhibits 1006, 1007, 1008, 1009, or 1010. Mot. Exclude 1–2.
This motion relies on the argument, discussed below, that each of Exhibits
1006–1010 is itself inadmissible. Id. As discussed below, however, we are
not persuaded that Exhibits 1006–1010 should be excluded as inadmissible.
Accordingly, we deny Patent Owner’s motion to exclude Dr. Poree’s
testimony.
2. Exhibit 1006: Varenna 2011
Patent Owner moves to exclude the phrases “OTTOBRE 2011,”
“ARTICOLO ORIGINALE,” “Ricevuto il 15 luglio 2011,” and “Accettato il
30 agosto 2011,” as they appear on the face of Varenna 2011. Mot. Exclude
2. The English translations of these phrases are, respectively, “October
2011,” “Original Article,” “Received on July 15, 2011,” and “Accepted on
August 30, 2011.” Ex. 1006, 227. According to Patent Owner, each of
these phrases is hearsay and should be excluded. Mot. Exclude 2; Reply
Mot. 1–3.
We are not persuaded that “October 2011” should be excluded.
Assuming that “October 2011” is hearsay, it is still admissible evidence
under Rule 807 of the Federal Rules of Evidence. Opp. Mot. 3–4. Under
Rule 807, a statement “is not excluded,” even if it is hearsay, if it meets two
requirements. First, the statement must be “supported by sufficient
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guarantees of trustworthiness—after considering the totality of
circumstances under which it was made and evidence, if any, corroborating
the statement.” Fed. R. Evid. 807(a)(1). Second, the statement must be
“more probative on the point for which it is offered than any other evidence
that the proponent can obtain through reasonable efforts.” Id. at 807(a)(2).
Here, both requirements are satisfied.
The statement “October 2011” on the face of Varenna 2011 is offered
to prove that Varenna 2011 was published in October 2011. This statement
is accompanied by several guarantees of trustworthiness. The statements
“Received on July 15, 2011” and “Accepted on August 30, 2011,” when
offered as corroboration of the October 2011 publication date, are not
hearsay. Fed. R. Evid. 801 (statement is hearsay only if offered in evidence
“to prove the truth of the matter asserted in the statement”). Accordingly,
they may be admitted for this purpose, and they corroborate a publication in
October 2011. Moreover, Exhibits 1038 and 1040 also provide some
evidence that Varenna 2011 was published in October 2011. Ex. 1038, 1
(article with same title as Varenna 2011 published in “Fascicolo 5 2011”);
Ex. 1040, 1 (“Fascicolo 5 2011” published in 2011). Thus, the record
contains sufficient guarantees of trustworthiness of Varenna 2011’s
statement that Varenna 2011 was published in October 2011.
On the question of whether Varenna 2011’s statement that
Varenna 2011 was published in October 2011 is “more probative on the
point for which it is offered than any other evidence that the proponent can
obtain through reasonable efforts,” Fed. R. Evid. 807(a)(2), it is difficult to
imagine any evidence more probative of the publication date of a journal
article than the article’s own contemporaneous statement about when it was
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published.21 Accordingly, we determine that the exception of Rule 807
applies, and we conclude that the statement “October 2011” in Varenna
2011 should not be excluded.
As noted above, the statements “Received on July 15, 2011,” and
“Accepted on August 30, 2011” in Varenna 2011 are not hearsay, because
they are offered not to prove the date when the article was received or
accepted but rather to corroborate the October 2011 publication date.
Accordingly, we conclude that these statements should not be excluded.
In reaching our decision on the unpatentability of the challenged
claims, as well as on the admissibility of the evidence Patent Owner seeks to
exclude, we do not rely on the statement “Original Article” on the face of
Varenna 2011. Accordingly, we dismiss Patent Owner’s motion to exclude
this statement as moot.
3. Exhibit 1007: Muratore
Patent Owner moves to exclude the statements “S/2004,” “2004-07-
19,” “Volume 5,” “Supplemento 1/2004,” “2004 ISSUE 1 SUPPLEMENT,”
and “Maratea (PZ), 16-18 aprile 2004,” as they appear on the face of
Muratore. Mot. Exclude 2–3. According to Patent Owner, each of these
phrases is hearsay and should be excluded. Id.; Reply Mot. 1–3.
As with the statements discussed above on the face of Varenna 2011,
the statements Patent Owner moves to exclude in Muratore are a statement
of the publication date (“Maratea (PZ), 16-18 aprile 2004”) and several

21 In reaching this determination, we note that the authenticity of
Varenna 2011 is not in dispute. Paper 8, 4–6 (objections to Ex. 1006, not
including any objection based on authenticity); Mot. Exclude 2 (not
preserving any objection based on authenticity).
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statements offered to corroborate that date. The statements offered as
corroboration are not hearsay, because they are not offered to prove their
own truth. As for the statement of the reference’s publication date, the
corroborating statements provide sufficient guarantees of trustworthiness,
and an article’s own statement about its publication date is certainly more
probative than any other evidence.22 Accordingly, we conclude that none of
the challenged statements in Muratore should be excluded, because they
satisfy the hearsay exception of Rule 807. Opp. Mot. 3–4.
4. Exhibit 1008: Gatti
Patent Owner moves to exclude two statements appearing on the face
of Gatti: “Published online: 17 Sep 2009” and “© 2009 Informa UK Ltd.”
Mot. Exclude 3–4. According to Patent Owner, each of these statements is
hearsay and should be excluded. Id.; Reply Mot. 1–3.
The statement regarding the copyright date is offered as corroboration
of the September 17, 2009 publication date, rather than as proof of the date
when copyright attached, so it is not hearsay. The statement that the article
was published on September 17, 2009, satisfies the hearsay exception of
Rule 807 for the same reasons discussed above with respect to similar
statements in Varenna 2011 and Muratore. Opp. Mot. 3–4. The record
contains sufficient guarantees of the trustworthiness of the statement. Ex.
1008, 1305 (copyright date); Ex. 1044 ¶¶ 3–6 (testimony regarding
publication process). In addition, an article’s own statement regarding its

22 In reaching this determination, we note that the authenticity of Muratore is
not in dispute. Paper 8, 6–7 (objections to Ex. 1007, not including any
objection based on authenticity); Mot. Exclude 2–3 (not preserving any
objection based on authenticity).
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publication date is more probative than any other evidence.23 Accordingly,
we conclude that none of the challenged statements in Gatti should be
excluded.
5. Exhibit 1009: Harden
Patent Owner moves to exclude several statements appearing on the
face of Harden: “PAIN 150 (2010) 268-274,” “Received 18 November
2009,” “Received in revised form 19 March 2010,” “Accepted 20 April
2010,” and “© 2010 International Association for the Study of Pain.” Mot.
Exclude 4–5. According to Patent Owner, each of these statements is
hearsay and should be excluded. Id.; Reply Mot. 1–3.
The statement “PAIN 150 (2010) 268-274” may be considered to
include a statement that Harden was published in 2010 that is offered to
prove that Harden was published in 2010. Even if we interpret the statement
as being offered for this hearsay purpose, however, it is admissible under
Rule 807 for the same reasons discussed above with respect to the
statements in Varenna 2011, Muratore, and Gatti. Opp. Mot. 3–4. The
remaining statements, all of which are offered for the non-hearsay purpose
of corroborating the 2010 publication date, provide sufficient guarantees of
trustworthiness, and there is no more probative evidence of an article’s
publication date than the article’s own statement on that point.24

23 In reaching this determination, we note that the authenticity of Gatti is not
in dispute. Paper 8, 7 (objections to Ex. 1008, not including any objection
based on authenticity); Mot. Exclude 3–4 (not preserving any objection
based on authenticity).
24 In reaching this determination, we note that the authenticity of Harden is
not in dispute. Paper 8, 7–8 (objections to Ex. 1009, not including any
objection based on authenticity); Mot. Exclude 4–5 (not preserving any
objection based on authenticity).
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Accordingly, we conclude that none of the challenged statements in Harden
should be excluded.
6. Exhibit 1010: Drummond
Patent Owner moves to exclude the statement “Pain Medicine 2010”
as it appears on the face of Drummond. According to Patent Owner, this
statement is hearsay and should be excluded. Mot. Exclude 5; Reply
Mot. 1–3.
As noted above, we do not rely on Drummond in reaching our
decision in this case. Accordingly, we dismiss Patent Owner’s motion to
exclude a portion of Drummond as moot.
7. Exhibit 1038: Relevance
Patent Owner moves to exclude the entirety of Exhibit 1038 as
irrelevant because, given the 2015 and 2019 dates on its face, “it has no
bearing upon the determination of what a [person of ordinary skill in the art]
would have known before the priority date of May 14, 2012.” Mot. Exclude
5–6.
Evidence is relevant, and therefore not inadmissible for irrelevance, if
“it has any tendency to make a fact more or less probable than it would be
without the evidence,” and “the fact is of consequence in determining the
action.” Fed. R. Evid. 401. Here, the fact in question is whether Varenna
2011 was published before May 14, 2012. Patent Owner points to the date
“1/2/2019” on the face of Exhibit 1038 (apparently the date the exhibit was
printed), as well as the year 2015 in a URL appearing on page 3 of the
exhibit as evidence that the exhibit cannot bear any relevance to what
happened before May 14, 2012. Mot. Exclude 5–6. But Exhibit 1038 also
states multiple times that Varenna 2011 was a part of “Fascicolo 5 2011.”
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Ex. 1038, 1–3. Accordingly, we cannot agree that the exhibit has no
tendency at all to make a 2011 publication date more likely. Opp. Mot. 10–
11. Thus, we are not persuaded that Exhibit 1038 should be excluded as
irrelevant.
8. Exhibits 1040, 1043–1046: Reply Evidence
Patent Owner argues that Exhibits 1040 and 1043–1046 should be
excluded as untimely because Petitioner could have submitted them with its
Petition but chose not to submit them until filing its Reply. Mot. Exclude 6–
10. But each of these exhibits is evidence supporting the printed-publication
status of Petitioner’s asserted prior-art references, and Petitioner is permitted
to file such evidence along with its Reply when responding to an argument
in Patent Owner’s Response regarding the status of the asserted references as
printed publications. Hulu, IPR2018-01039, Paper 29 at 15 (precedential).
Here, Patent Owner raised such an argument, Response 6–18, so Petitioner’s
submission of Exhibits 1040 and 1043–1046 was authorized. We deny
Patent Owner’s motion to exclude these references as untimely.
9. Exhibit 1040: Relevance
Patent Owner moves to exclude the entirety of Exhibit 1040 as
irrelevant. Mot. Exclude 10–11. Here, as with Exhibit 1038, the fact in
question is whether Varenna 2011 was published before May 14, 2012.
Patent Owner argues that Exhibit 1040 does not make such a publication
date more or less likely. We disagree. Exhibit 1040 lists “Fascicolo 5 2011”
under the heading “2011” on a page with headings for other years from 2012
through 2019. Ex. 1040, 1. In combination with the evidence showing that
Varenna 2011 was published as part of “Fascicolo 5 2011,” Ex. 1038, 1–3,
this supports a finding that Varenna 2011 was published in 2011.
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Accordingly, we are not persuaded that Exhibit 1040 should be excluded as
irrelevant.
10. Exhibit 1043: Relevance
Patent Owner moves to exclude the entirety of Exhibit 1043 as
irrelevant. Mot. Exclude 11–12. Here, the fact in question is whether
Muratore was published before May 14, 2012. Patent Owner argues that
Exhibit 1043 does not make such a publication date more or less likely. We
disagree. Exhibit 1043 contains the declaration testimony of David E.
Cannady, who testifies that he has “nearly forty years of experience
retrieving articles from the [National Library of Medicine],” that the copy of
Muratore he retrieved from the library bore “a date/time stamp of ‘2004-07-
19 10:33:34,’” and that, based on his experience, this stamp “represents the
date/time Muratore was received by the [library].” Ex. 1043 ¶¶ 1, 7. This
testimony makes a publication date before May 14, 2012, more likely,
because the article likely was printed and distributed near the time it was
received by the National Library of Medicine in 2004. Accordingly, we are
not persuaded that Exhibit 1043 should be excluded as irrelevant.
11. Exhibit 1043: Personal Knowledge
Patent Owner also seeks to exclude the statement in Exhibit 1043 that
materials received by the National Library of Medicine are “added to the
[library’s] General Collection—and therefore available and accessible to the
public . . . within 7-10 days of receipt of the publication.” Mot. Exclude 12–
13. Patent Owner argues that this statement is beyond the witness’s personal
knowledge and therefore inadmissible under Fed. R. Evid. 602. Id. We do
not rely on this testimony in reaching our decision in this case, so we dismiss
this portion of Patent Owner’s motion to exclude as moot.
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12. Exhibit 1044: Relevance
Patent Owner moves to exclude the entirety of Exhibit 1044 as
irrelevant. Mot. Exclude 13–14. Here, the fact in question is whether Gatti
was published before May 14, 2012. Patent Owner argues that Exhibit 1044
does not make such a publication date more or less likely. We disagree.
Exhibit 1044 contains the declaration testimony of Corinne Militello, Esq.,
who testifies that she investigated the process her employer undertook to
publish Gatti and that her investigation revealed dates for various steps in
the publication process that are consistent with a publication date of
September 17, 2009. Ex. 1044 ¶¶ 1–6. This testimony clearly makes a
publication date before May 14, 2012, more likely. Accordingly, we are not
persuaded that Exhibit 1044 should be excluded as irrelevant.
13. Exhibits 1045 and 1046: Relevance
Patent Owner moves to exclude the entirety of Exhibit 1045 and its
English translation, Exhibit 1046, as irrelevant. Mot. Exclude 14–15. Here,
the fact in question is whether Varenna 2011 was published before May 14,
2012. Patent Owner argues that Exhibits 1045 and 1046 do not make such a
publication date more or less likely. We disagree. These exhibits provide
testimony that some copies of Varenna 2011 were distributed to conference
attendees on September 26, 2011, and that other copies were sent to
subscribers in October 2011. Ex. 1046, 3. This testimony clearly makes a
publication date before May 14, 2012, more likely, because no copies of an
article published after May 14, 2012, could have been distributed either on
September 26, 2011, or in October 2011. Accordingly, we are not persuaded
that Exhibits 1045 and 1046 should be excluded as irrelevant.
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14. Exhibit 1046: Hearsay
Patent Owner moves to exclude the entirety of Exhibit 1046 as
hearsay. Mot. Exclude 15. We are not persuaded that Exhibit 1046 is
hearsay. The exhibit is offered to corroborate a publication date of
October 2011 for Varenna 2011, rather than as proof of the content of the
statements it contains (that some copies of the article were distributed on
September 26, 2011, or that other copies were sent to subscribers in October
2011). Reply 11. Accordingly, we are not persuaded that Exhibit 1046
should be excluded as hearsay.
15. Conclusion as to Motion to Exclude
We dismiss as moot those portions of Patent Owner’s motion to
exclude that seek to exclude exhibits on which we do not rely in reaching
our decision. Those portions are those that seek to exclude (1) the statement
“Original Article” on the face of Ex. 1006 as hearsay, (2) portions of Exhibit
1010 as hearsay, and (3) portions of Exhibit 1043 for lack of personal
knowledge. We deny the remainder of Patent Owner’s motion to exclude.
CONCLUSION25
Upon consideration of the papers and evidence before us, we
determine that Petitioner has proven by a preponderance of the evidence that

25 Should Patent Owner wish to pursue amendment of the challenged claims
in a reissue or reexamination proceeding subsequent to the issuance of this
Decision, we draw Patent Owner’s attention to the April 2019 Notice
Regarding Options for Amendments by Patent Owner Through Reissue or
Reexamination During a Pending AIA Trial Proceeding, 84 Fed. Reg.
16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application
or a request for reexamination of the challenged patent, we remind Patent
Owner of its continuing obligation to notify the Board of any such related
matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2).
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claims 1–30 are unpatentable as obvious over the combination of Harden
and one or more of Varenna 2011, Gatti, and Muratore.26 We also determine
that Petitioner has not shown that any claim of the ’338 patent is
unpatentable either for indefiniteness or for lack of written description.
Finally, we partially deny and partially dismiss Patent Owner’s motion to
exclude evidence.

Claims
35
U.S.C. §

Reference(s)/Basis
Claims
Shown
Unpatentable
Claims
Not Shown
Unpatentable
1–16 103 Harden; Varenna
2011, Gatti,
Muratore
1–16
17–30 112 Indefiniteness 17–30
17–30 103 Harden;
Drummond;
Varenna 2011,
Gatti, Muratore
17–30
1–30 112 Written
Description
1–30
Overall
Outcome
1–30

26 Although Petitioner includes Drummond as part of its obviousness ground
challenging claims 17–30, we do not rely on any teaching or suggestion of
Drummond in concluding that Petitioner has proven these claims obvious.
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ORDER
It is hereby
ORDERED that Petitioner has proven by a preponderance of the
evidence that claims 1–30 of U.S. Patent No. 10,052,338 B2 are
unpatentable;
FURTHER ORDERED that, pursuant to 35 U.S.C. § 318(b), upon
expiration of the time for appeal of this decision, or the termination of any
such appeal, a certificate shall issue canceling claims 1–30 of U.S. Patent
No. 10,052,338 B2;
FURTHER ORDERED that Patent Owner’s motion to exclude
portions of Exhibit 1010 for hearsay and portions of Exhibit 1043 for lack of
personal knowledge is dismissed as moot;
FURTHER ORDERED that Patent Owner’s motion to exclude is
otherwise denied; and
FURTHER ORDERED that, because this is a Final Written Decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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PETITIONER:
Daniel J. Minion
Bruce C. Haas
VENABLE LLP
dminion@venable.com
bchaas@venable.com

PATENT OWNER:
Brent A. Johnson
R. Parrish Freeman
MASCHOFF BRENNAN
bjohnson@mabr.com
pfreeman@mabr.com