Soll et al.v.Roepke et al. V. Soll et al.

Patent Trials and Appeals Board

Jun 24, 2019

14627499 - (J) (P.T.A.B. Jun. 24, 2019)

-1-
BoxInterferences@uspto.gov Entered: June 24, 2019
Tel: 571-272-9797

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEALS BOARD

RAINER ROEPKE,
CARSTEN SCHMIDT, SUSI ALTEHELD,
and CARINA HANG,

Junior Party
(Application 15/634,924)
v.

MARK DAVID SOLL,
DIANE LARSEN, SUSAN MANCINI CADY, PETER CHEIFETZ,
IZABELA GALESKA, and SAIJUN GONG,

Senior Party
(Patent 9,259,417 and Application 15/009,996).

Patent Interference No. 106,090
(Technology Center 1600)

Before: SALLY GARDNER LANE, JAMES T. MOORE, and DEBORAH KATZ,
Administrative Patent Judges.

LANE, Administrative Patent Judge.

JUDGMENT - Bd. R. 127(a)

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Roepke Motion 1 for judgment against Soll on the basis that all the involved 1
Soll claims are unpatentable for insufficient written description was granted. 2
(Decision, Paper 220). As all the involved claims of senior party Soll are 3
unpatentable to Soll, we need not, and do not, continue the interference proceeding 4
and enter judgment against Soll. 5
Order 6
It is 7
ORDERED that judgment on priority is entered against senior party Soll as 8
to Count 1, the sole Count of the interference (Declaration, Paper 1, 5); 9
FURTHER ORDERED that claims 1-24 of Soll patent 9,259,417, which 10
correspond to Count 1, are CANCELLED (Declaration, Paper 1, 5); 35 U.S.C. 11
§ 135(a);1 12
FURTHER ORDERED that claims 16-18, 21, 23-24, and 26-67 of Soll 13
application 15/009,996, which correspond to Count 1, are FINALLY REFUSED 14
(Declaration, Paper 1, 5); 35 U.S.C. § 135(a); 15
FURTHER ORDERED that the parties are directed to 35 USC § 135(c) and 16
Bd. R. 205 regarding the filing of settlement agreements; 17
FURTHER ORDERED that a party seeking judicial review timely serve 18
notice on the Director of the United States Patent and Trademark Office; 19
37 C.F.R. §§ 90.1 and 104.2. See also Bd. R. 8(b). Attention is directed to Biogen 20
Idec MA, Inc., v. Japanese Foundation for Cancer Research, 785 F.3d 648, 21

1 Any reference to a statute in this Judgment is to the statute that was in effect
on March 15, 2013 unless otherwise indicated. See Pub. L. 112-29, § 3(n), 125
Stat. 284, 293 (2011).

-3-
654–57 (Fed. Cir. 2015) (determining that pre-AIA § 146 review was eliminated 1
for interference proceedings declared after September 15, 2012); and 2
FURTHER ORDERED that a copy of this judgment be entered into the 3
administrative records of the involved Roepke application and the involved Soll 4
patent and application. 5

cc (via email):

Attorney for Roepke:

Janelle D. Waack, Esq.
R. Gregory Parker, Esq.
BASS, BERRY & SIMS PLC
jwaack@bassberry.com
gparker@bassberry.com

David J. Kerwick, Esq.
MERCK SHARP & DOHME CORP.
david.kerwick@merck.com

Raymond N. Nimrod, Esq.
Amanda K. Antons, Ph.D.
QUINN EMANUEL URQUHART & SULLIVAN, LLP
raynimrod@quinnemanuel.com
amandaantons@quinnemanuel.com

Attorney for Soll:

Dr. Judy Jarecki-Black, Esq.
Dr. John E. Ezcurra, P.A.
BOEHRINGER INGELHEIM ANIMAL HEALTH
Judy.Jarecki@Merial.com
John.Ezcurra@Merial.com

-4-

Blas P. Arroyo, Esq.
Matthew W. Howell, Esq.
ALSTON & BIRD LLP
Blas.Arroyo@Alston.com
Matthew.Howell@Alston.com
BoxInterferences@uspto.gov Entered: June 24, 2019
Tel: 571-272-9797

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

RAINER ROEPKE,
CARSTEN SCHMIDT, SUSI ALTEHELD,
and CARINA HANG,

Junior Party
(Application 15/634,924)
v.

MARK DAVID SOLL,
DIANE LARSEN, SUSAN MANCINI CADY, PETER CHEIFETZ,
IZABELA GALESKA, and SAIJUN GONG,

Senior Party
(Patent 9,259,417 and Application 15/009,996).

Patent Interference No. 106,090
(Technology Center 1600)

Before SALLY GARDNER LANE, JAMES T. MOORE, and DEBORAH KATZ,
Administrative Patent Judges.

LANE, Administrative Patent Judge.

Decision – Motions – Bd. R. 121(a)

2

I. Introduction 1
We have before us for decision motions filed in the preliminary phase of this 2
interference.1 Junior party Rainer Roepke, Carsten Schmidt, Susi Alteheld, 3
and Carina Hang (Roepke)2 filed five substantive motions, one being a contingent 4
responsive motion. Roepke also filed a motion to exclude. Senior party Mark 5
David Soll, Diane Larsen, Susan Mancini Cady, Peter Cheifetz, Izabela Galeska, 6
and Saijun Gong (Soll)3 filed five substantive motions one of which has been since 7
withdrawn. 8
Roepke moves for judgment on the basis that the involved Soll claims are 9
unpatentable for lack of written description (RM1, Paper 103) and lack of 10
enablement (RM2, Paper 111). Roepke also filed a motion challenging Soll’s 11
accorded benefit (RM3, Paper 113), a motion seeking additional Roepke benefit 12
(RM4, Paper 112), a contingent responsive motion seeking to add a claim to its 13
involved application (RM5, Paper 141), and a motion to exclude (RM6, Paper 14
217). Each of these Roepke motions was opposed by Soll. (SO1, Paper 167; SO2, 15
Paper 165; SO3, Paper 166, SO4, Paper 160; SO5, Paper 161; SO6, Paper 218). 16
Replies were filed by Roepke. (RR1 to RR6, Papers 201-205, 219, respectively). 17
Soll moves for judgment on the basis that the involved Roepke claims are 18
unpatentable for lack of written description (SM2, Paper 104), lack of enablement 19

1 We have determined that no oral argument is necessary. Bd. R. 124(a).
2 Roepke identifies its real parties in interest as Intervet Inc., and Merck &
Co., Inc., noting that Intervet Inc. is a wholly owned subsidiary of Merck & Co.,
Inc. (Roepke Real Party Notice, Paper 11).
3 Soll identifies its real party in interest as Merial, Inc., noting Merial, Inc. to
be wholly-owned by Boehringer Ingelheim and which now is known also as
Boehringer Ingelheim Animal Health. (Soll Real Party Notice, Paper 8).
3

(SM3, Paper 105), and indefiniteness (SM4, Paper 106). Soll also filed a motion 1
challenging Roepke’s accorded benefit date (SM1, Paper 108) and a motion to 2
substitute a count (SM5, Paper 107).4 Soll withdrew its motion to substitute a 3
count prior to the time oppositions were due to be filed and we do not consider this 4
motion. (Soll Notice, Paper 146). Each of the remaining Soll motions was 5
opposed by Roepke. (RO1, Paper 171; RO2, Paper 164; RO3, Paper 169, RO4, 6
Paper 149).5 Replies were filed by Soll. (SR1 to SR4, Papers 206-209, 7
respectively). 8
A motion must provide a showing, supported with appropriate evidence, 9
such that, if unrebutted, it would justify the relief sought. The moving party has 10
the burden of proof. Bd. R. 208(b). 11
The Board may take up motions for decision in any order, may grant, deny, 12
or dismiss any motion, and may take such other action as may be appropriate to 13
secure the just, speedy, and inexpensive determination of the proceeding. Bd. R. 14
125(a). We exercise our discretion to first consider each party’s motion for 15
judgment on the basis that its opponent’s claims lacks written description support 16
since such motions may, in certain circumstances, raise a threshold issue. Bd. R. 17
201. 18

4 Soll filed separately an appendix to each of its Motions 1 to 5 to provide the
required list of evidence Soll relied upon in each motion. (Appendices, Papers
124-128, respectively). The Board authorized Soll to file the appendices at time
period 2. (Order, Paper 117).
5 Soll appears to have filed required appendices to its oppositions as separate
papers. (Soll Opposition 1-5 Appendices, Papers 168, 172, 170, 162 and 163,
respectively).
4

We GRANT Roepke Motion 1. We DENY Soll Motions 2, 3, and 4. We 1
DISMISS as moot the remaining motions. 2
II. Discussion 3
All findings of fact set forth in the decision are supported by a 4
preponderance of the evidence. 5
6
A. Count and claims 7
There is one count in the interference. That count, Count 1, is claim 19 of 8
Roepke’s involved application 15/634,924(’924) or claim 1 of Soll’s involved 9
patent 9,259,417 (’417) or claim 16 of Soll’s involved application 15/009,996 10
(’996).6 (Declaration, Paper 1, 5). All of the claims of Roepke’s involved 11
application and all of the claims of Soll’s involved patent and application 12
correspond to Count 1. 13
Each of the claims making up Count 1 is directed to a solid soft chewable 14
veterinary composition effective for treating and/or controlling flea or tick 15
infestation in an animal comprising the isoxazoline active ingredient fluralaner or a 16
pharmaceutically acceptable salt thereof, and a carrier that includes PEG 3350 as a 17
forming agent, sodium lauryl sulfate as a surfactant, corn starch as a filler and 18
glycerol as a humectant, with claim 16 of the Soll involved application being 19
directed to a method of using the composition. 20

6 The ’417 Patent specification appears to be substantively the same as that of
the involved pending application 15/009,996. (SO1, Paper 167, 2:14-18, citing,
Witchey-Lakshmanan Declaration, Ex. 1018, ¶ 2; Polli Dec., Ex. 2008, ¶¶ 30-31).
In this Decision we have cited to the ’417 specification which was filed by Roepke
as Exhibit 2017.
5

Roepke claim 19, reproduced below, is illustrative of the Roepke involved 1
claims: 2
19. A solid soft chewable veterinary composition effective for treating 3
and/or controlling flea or tick infestation in an animal comprising: 4
a) an isoxazoline active ingredient of 4-[5-(3,5-Dichlorophenyl)-5-5
trifluoromethyl-4,5-dihydroisoxazol-3-yl]-2-methyl-N-[(2,2,2-trifluoro-6
ethylcarbamoyl)-methyl]-benzamide or a pharmaceutically acceptable salt 7
thereof at a concentration between 5% and 20% by weight; 8
b) a forming agent, a surfactant, a filler and a humectant, wherein the 9
forming agent is PEG 3350; the surfactant is sodium lauryl sulfate at a 10
concentration of 2% (w/w); the filler is corn starch and the humectant is 11
glycerol; 12
c) wherein the effect is achieved at a dosage based upon the weight 13
and type of animal; and 14
d) wherein the composition is effective for fleas or ticks by 15
administration to the animal every 2 or 3 months. 16
17
(Roepke Clean Copy of Claims, Paper 9, 3). 18
19
Claim 1 of Soll’s involved patent, reproduced below, is illustrative of the 20
Soll involved claims: 21
1. A solid soft chewable veterinary composition effective for treating and/or 22
preventing fleas or ticks infection or infestation in an animal comprising: 23
a) an isoxazoline active agent of Formula (II) at a concentration of 24
about 5% to about 15% by weight: 25
26
27
28
29
6

or a pharmaceutically acceptable salt thereof; and 1
2
b) a pharmaceutically acceptable carrier, wherein the carrier 3
comprises a binder, a surfactant, a filler and a humectant, wherein the binder 4
is PEG 3350; the surfactant is sodium lauryl sulfate at a concentration of 5
about 1 to about 5% (w/w); 6
the filler is corn starch or pre-gelatinized corn starch or a combination 7
thereof; and the humectant is glycerol; 8
wherein the effect is achieved at a dosage of about 10 mg/kg to about 9
100 mg/kg of active agent of Formula (II); and 10
wherein the composition is effective for fleas for at least 79 days. 11
12
(Soll Second Clean Copy of Claims, Paper 16, 4). 13
14
B. Level of Skill in the Art 15
One of ordinary skill in the art is a person who is presumed to know the 16
relevant prior art and includes, as asserted by the parties, formulation specialists in 17
the field of the invention. In re GPAC, 57 F.3d 1573, 1579, (Fed. Cir. 1995). (Polli 18
Declaration, Ex. 2008, ¶¶21-23; Witchey-Lakshmanan Declaration, Ex. 1001, ¶8). 19
The parties agree and the record supports that the technology that is the subject 20
matter of the involved claims was highly unpredictable, in particular with respect 21
to changing surfactants. (RM1, 3:13-14; Polli Declaration, Ex. 2008, ¶128; 22
Witchey-Lakshmanan Deposition Transcript, Ex. 1026, 179:16-180:3; Witchey-23
Lakshmanan Declaration, Ex. 1001, ¶57). 24

7

C. Written Description 1
1. Legal Principles 2
“To satisfy [the written description] requirement, the specification must 3
describe the invention in sufficient detail so ‘that one skilled in the art can clearly 4
conclude that the inventor invented the claimed invention as of the filing date 5
sought.’” In re Alonso, 545 F.3d, 1015, 1019 (Fed. Cir. 2008), citing Lockwood v. 6
Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). We thus consider what 7
the specification reasonably would have conveyed to one of ordinary skill in the 8
art, as well as the predictability of the art, in evaluating whether the specification 9
provides sufficient written description for the claimed invention. Bilstad v. 10
Wakalopulos, 386 F.3d 1116, 1125 (Fed. Cir. 2004); Noelle v. Lederman, 355 F.3d 11
1343, 1350 (Fed. Cir. 2004). “Such description need not recite the claimed 12
invention in haec verba but must do more than merely disclose that which would 13
render the claimed invention obvious.” ICU Medical, Inc. v. Alaris Medical 14
Systems, Inc. 558 F.3d 1368, 1377 (Fed. Cir. 2009). A “mere wish or plan” for 15
obtaining the claimed invention does not satisfy the written description 16
requirement. Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 17
(Fed. Cir. 1997). Although a particular composition later claimed may fall within 18
the scope of a larger described genus, guidance or “blazemarks”, are required for 19
description of the particular claimed composition. See In re Ruschig, 54 C.C.P.A. 20
1551, 379 F.2d 990, 995 (CCPA 1967) (“Appellants are pointing to trees. We are 21
looking for blaze marks which single out particular trees. We see none.”). 22
Claims that are broader in scope than the supporting disclosure by omitting 23
an essential element of the invention do not comply with the written description 24
8

requirement. Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473, 1480, (Fed. 1
Cir. 1998). 2
In interference proceedings the language of each claim is given its broadest 3
reasonable interpretation as read in light of the specification as it would be 4
interpreted by one of ordinary skill in the art. See In re Sneed, 710 F.2d 1544, 1548 5
(Fed. Cir. 1983) (citations omitted). A claim that is “substantially copied” is 6
construed in view of its originating disclosure for purposes of evaluating written 7
description. Agilent Techs. Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1375 (Fed. Cir. 8
2009). (“To be clear, as the court explained in Rowe, when a party challenges 9
written description support for an interference count or the copied claim in an 10
interference, the originating disclosure provides the meaning of the pertinent claim 11
language.”). 12
2. Roepke Motion 1 13
In its Motion 1, Roepke seeks judgment against Soll on the basis that the 14
Soll claims lack sufficient written description. 15
We GRANT this motion. 16
The claims of Soll’s involved patent, illustrated by Soll’s involved patent 17
claim 1 above, are directed to a solid soft chewable veterinary composition for 18
treating and/or preventing a flea or tick infection or infestation in an animal having 19
the five part component composition of ’417 claim 1. (Soll Second Clean Copy of 20
Claims, Paper 16, 4). The claims of Soll’s involved application are directed to a 21
method for treating and/or preventing a flea or tick infestation in an animal 22
comprising administering to the animal an effective amount of this solid soft 23
chewable veterinary composition. (Soll Second Clean Copy of Claims, Paper 16, 24
9). 25
9

As Roepke notes all the Soll involved claims require (1) fluralaner (the 1
formula II compound) as the active agent, (2) sodium lauryl sulfate (SLS) as a 2
surfactant, (3) PEG 3350 as a binder, (4) glycerol as a humectant, and (5) corn 3
starch as a filler, and at least 79-day flea efficacy. (RM1, Paper 103, 12:6-13:7, 4
citing ’417 patent, Ex. 2017, 83:43-84:5; RM1, SMF71, relevant portion admitted 5
at SO1 Appendix, Paper 168). 6
Roepke argues that it was only after learning of the Invervet commercial 7
product Bravecto® that Soll arrived at its present claims. Roepke notes, and Soll 8
concedes, that Soll first presented the involved claims in 2015, after publication of 9
product information for Intervet’s Bravecto® revealed it to contain fluralaner as an 10
active ingredient and including the excipients sodium lauryl sulfate (SLS), 11
macrogel 335 (PEG 3350), glycerol, and corn starch. (RM1, Paper 103, 11:6-12:5, 12
SMFs 10-12, relevant portions admitted at SO1, Appendix, Paper 168). Roepke 13
argues, essentially, that Soll used information about Bravecto® revealed in the 14
product information publication as a guide for its present claims and for 15
establishing the importance of the selection of each specific component of its 16
involved claims from the laundry lists of excipients provided as well as the 79 day 17
flea efficacy. (RM1, Paper 103, 1:13-2:21; 11:6-12:5).8 18

7 Statement of material fact.
8 Roepke asserts that its Motion 1 raises a threshold issue. (RM1, Paper 103,
1:6-8). A threshold issue is an issue that, if resolved in favor of the movant, would
deprive the opponent of standing in the interference. Our rules state that threshold
issues may include unpatentability for lack of written description where an
applicant first made an involved claim only after publication of the movant’s
application or issuance of the movant’s patent. Bd. R. 201. Roepke points to
Soll’s presentation of claims after learning of the Bravecto® product, but Roepke
does not assert, or direct us to evidence to support, that Soll made its involved
10

Roepke argues that a result of Soll later adding claims based on the 1
Bravecto® product is that the Soll specifications do not provide sufficient 2
“blazemarks” in the form of preferences such that one skilled in the art would have 3
understood Soll to have had possession of a composition or method having the 4
requirements of the Soll involved claims. Roepke argues that rather each of the 5
five required ingredients appear as one of many options on various, some 6
extensive, laundry lists of active agents and excipients but nowhere does Soll 7
disclose the specific combination of ingredients claimed or the claimed efficacy 8
thereof. (RM1, Paper 103, 16:8-17:4, citing, e.g., Polli Dec., Ex. 2008, ¶¶ 64-69). 9
Soll concedes its specifications do not disclose an exemplary formulation 10
that contains all of the specific claimed five ingredients together. (RM1, SMF 18, 11
admitted SO1 at Appendix, Paper 168). Further, as noted above, Soll does not 12
dispute that it first learned of that specific combination from publications providing 13
the ingredient list for Intervet’s BRAVECTO® product and then later added claims 14
to that combination. (RM1, SMFs 10, 12, admitted SO1 Appendix, Paper 168). 15
Soll argues though that formulations with an isoxazoline active agent and including 16
the four classes of excipients required by its claims are described in its involved 17
specifications. Soll asserts that, within the general classes of active agents and 18
excipients described in its specification, the active fluralaner and each of the 19
specifically claimed excipients are described as suitable. Soll argues that therefore, 20
the claimed specific five ingredient combination would have been understood by a 21

claims only after publication of Roepke’s involved application or otherwise
explain why we should consider Roepke Motion 1 to raise a threshold issue.
Accordingly we do not do so.
11

person of skill in the art to be disclosed by the involved specifications. (SO1, Paper 1
167, 1:20-2:12). 2
Soll provides the following structures of afoxolaner (Compound A below), 3
used in exemplified formulations of the Soll specifications, and the claimed 4
fluralaner (Compound B below), in support of Soll’s contention that the two are 5
“highly similar.” 6
7
8
9
10
(SO1, Paper 167, 3:14-4:4; 12:12-14:2, citing, e.g., Witchey-Lakshmanan Second 11
Declaration, Ex. 1018, ¶¶37-40; Wentland Declaration, Ex. 2009, ¶24). 12
There appears to be no dispute that arriving at the Soll involved claims 13
requires selections from within broader groups found in the Soll specification and 14
that there is no specific disclosure of a formulation having each component of the 15
claimed subject matter. Roepke has the burden of proof to show that Soll did not 16
describe, i.e., have possession of, the claimed invention. A question before us is 17
whether Roepke has shown, as Roepke asserts, that the Soll specifications provide 18
insufficient guidance, or “blazemarks”, to have led one skilled in the art to a 19
composition and method having the limitations of the Soll claims. 20
In deciding Roepke Motion 1 we have considered, inter alia, the testimony 21
12

of Dr. James E. Polli (Ex. 2008),9 Dr. Mark P. Wentland (Ex. 2009),10 and Dr. 1
Daniel E. Snyder (Ex. 2010).11 2
Each of these witnesses testified that the Soll specifications do not disclose a 3
formulation with the claimed five-ingredient combination, nor do they disclose any 4
other formulations with fluralaner as the active agent or with SLS as the surfactant. 5
Further, according to these witnesses, the Soll specifications would not have 6
guided one skilled in the art to the particular selections necessary to arrive at the 7
presently claimed composition and method with its claimed efficacy. (RM1, Paper 8
103, 5:21-10:2, citing e.g., Polli Declaration, Ex. 2008, ¶¶ 63-118; Wentland 9
Declaration, Ex. 2009, ¶¶ 35, 38, 43; Snyder Declaration, Ex. 2010, ¶¶ 32-33.) 10
These witnesses explain that the underlying reasons for their opinions are, inter 11
alia, that: 12
(1) the Soll involved specifications do not describe a formulation using 13
fluralaner instead focusing on the genus of Formula I compounds, and more 14
specifically afoxolaner, and other non-isoxazoline active ingredients (RM1, 16:16-15
25; Polli Declaration, Ex. 2008, ¶¶ 68, 69; Wentland Declaration, Ex. 2009, ¶ 35; 16

9 Based on his educational, professional and practical experience as discussed
further in his declaration testimony (Polli Declaration, Ex. 2008, ¶¶5-12) and
curriculum vitae (Ex. 2048), we find Dr. Polli to be qualified to testify regarding
the technical subject matter involved in the interference.
10 Based on his educational, professional and practical experience as discussed
further in his declaration testimony (Wentland Declaration, Ex. 2009, ¶¶4-12) and
curriculum vitae (Ex. 2049), we find Dr. Wentland to be qualified to testify
regarding the technical subject matter involved in the interference.
11 Based on his educational, professional and practical experience as discussed
further in his declaration testimony (Snyder Declaration, Ex. 2010, ¶¶ 6-16) and
curriculum vitae (Ex. 2050), we find Dr. Snyder to be qualified to testify regarding
the technical subject matter involved in the interference.

13

Snyder Declaration, Ex. 2010, ¶ 32; ’417 patent, Ex. 2017, 20:22-40; Tables 1-49, 1
60:45-13;72:31); 2
(2) afoxolaner is the only isoxazoline compound administered in Soll’s 3
disclosed efficacy studies for treatment of fleas and ticks in dogs (RM1, Paper 103, 4
7:14-16; Snyder Declaration, Ex. 2010, ¶ 59, ’417 patent, Ex. 2017, 72:34-79:8); 5
(3) the Soll specifications include long laundry lists of non-active excipients, 6
including surfactants, solvents, fillers, binders, humectants, disintegrants, 7
antioxidants, preservatives, pH stabilizers, lubricants, processing aids, anti-8
microbial agents, and flavoring agents and noting that, for example, 74 surfactants 9
are named including generic broader classes of surfactants, each of which have 10
numerous members and including both non-ionic and ionic surfactants one of 11
which is the claimed SLS (RM1, Paper 103, 20:18-21:13; Polli Declaration, Ex. 12
2008, ¶¶ 70-76, 82; Wentland Declaration, Ex. 2009, ¶36, 38; ’417 patent, Ex. 13
2017, 42:46-47:62); 14
(4) the Soll specifications provide laundry lists for binders, humectants, and 15
fillers that include, respectively, PEG 3350, glycerol, and corn starch as possible 16
options and that based on permutations of the specifically identified excipients in 17
each list (and not considering that each list refers also to broad categories that 18
include many more options), the number of excipient combinations is well in 19
excess of five million with little guidance being provided on how to select specific 20
combinations of excipients among those many options to achieve the high 21
bioavailability said to be a goal of the Soll claimed formulation. (RM1, 21:1-3; 22
Polli Declaration, Ex. 2008, ¶ 117); 23
(5) Soll’s Example 1 provides 49 formulations in Table 1-49, none of which 24
use SLS as the surfactant but which instead use non-ionic surfactants with 25
14

afoxolaner being the only isoxazoline active agent used in the formulations. (RM1, 1
Paper 103, 17:21-19:5; Wentland Declaration, Ex. 2009, ¶ 40-43; Polli 2
Declaration, Ex. 2008, ¶¶ 81-82; see also, Summary Table of Soll formulations, 3
Ex. 2044); 4
(6) the only teaching within the Soll specifications on how to obtain close to 5
79-day flea efficacy comes from examples using afoxolaner as the active 6
ingredient and the non-ionic surfactant polyethylene glycol 12-hydroxystearate, 7
along with povidone as the binder, soy protein fines as the filler, and 8
caprylic/capric triglyceride as the solvent. (RM1, Paper 103, 23:19-25:8; Polli 9
Declaration, Ex. 2008, ¶ 59; Snyder Declaration, Ex. 2010, ¶¶ 58-62; ’417 patent, 10
Ex. 2017, Example 2 and Table 6); 11
(7) the Soll specifications teach that surfactant selection is critical and that 12
the effectiveness of excipient combinations was unpredictable such that a skilled 13
person reading the Soll specifications would not have been able to conclude that 14
Soll possessed an invention directed to a formulation that could achieve a 79-day 15
flea efficacy using fluralaner and the recited excipient combination with SLS 16
(RM1, Paper 103, 25:9-26:13; Snyder Declaration, Ex. 2010, ¶¶ 53-65, 68; Polli 17
Declaration, Ex. 2008, ¶¶ 126-129.). 18
Soll urges that, despite the lack of an explicit disclosure of a single 19
formulation containing each of the required components of its claims, the Soll 20
specifications do explicitly disclose that its invention covers the combination of 21
four specific classes of excipients (surfactant, humectant, binder, and filler), as 22
well as each of the four specifically claimed and well-known excipients within 23
each class. Soll further argues that since fluralaner is specifically called out in its 24
specifications, even though not found in an exemplified formulation having the 25
15

claim components, there is written description for using such as an active 1
ingredient in combination with the excipients of its claims. Finally Soll argues that 2
its examples support description of 79 day efficacy because they show that using a 3
formulation containing afoxolaner (not the claimed fluralaner or the other 4
excipients of the claim) resulted in a flea efficacy through at least 72 days. Soll 5
urges that “[w]hile the data …does not expressly extend beyond 72 days, a person 6
of skill in the art reviewing the data would recognize that 79-day treatment efficacy 7
is readily achievable— particularly since the data … was generated using active 8
ingredient dosages at least three times lower than the smallest claimed dosage.” 9
(SO1, Paper 167, 9:7-10:23, citing , e.g., Witchey-Lakshmanan Declaration, Ex. 10
1018, ¶¶ 75, 79, 86, 87; Snyder Deposition Transcript, Ex. 2074,175:7-22, 194:18-11
195:13; 209:5-212:8; ’417 patent, Ex. 2017, 58:40-44, 59:10-15). 12
In support of its position Soll directs us to the testimony of its witness Dr. 13
Leonore C. Witchey-Lakshmanan12 and we have considered those portions of Dr. 14
Witchey-Lakshmanan testimony pointed out to us by Soll. Essentially Dr. 15
Witchey-Lakshmanan testified to her opinion that each component of the claimed 16
invention is present within the Soll specifications and that one skilled in the art 17
would have realized, based on the fact that each individual component of the 18
claimed composition and method is named explicitly in the Soll specifications, that 19

12 Based on her educational, professional and practical experience as discussed
further in her declaration testimony (Witchey-Lakshmanan Declaration, Ex. 1001,
¶¶1-2) and curriculum vitae (Ex. 1002), we find Dr. Witchey-Lakshmanan to be
qualified to testify regarding the technical subject matter involved in the
interference. For reasons discussed further below in this decision, we make this
finding without needing to consider Roepke Motion 6 which seeks to exclude the
entirety of Dr. Witchey-Lakshmanan’s testimony on the basis that she is not so
qualified.
16

Soll possessed the combination of the individual components that was later 1
claimed. (SO1, Paper 167, 18:7-17, citing Second Witchey-Lakshmanan 2
Declaration, Ex. 1018, ¶¶ 26-71). 3
We agree with Soll that it need not have provided an example or an explicit 4
disclosure of a formulation containing each of the five specific required 5
components of its claims. All that it needed for description is that the disclosure 6
reasonably conveyed to persons skilled in the art that Soll had possession of the 7
claimed subject matter. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1570, (Fed. 8
Cir. 1996), citing In re Edwards, 568 F.2d 1349, 1351–52, (CCPA 1978). 9
We agree with Soll that “fluralaner is explicitly disclosed by Soll as a 10
suitable active ingredient and identified as ‘Compound B’” (SO1, Paper 167, 11
11:11-19, citing, e.g., Second Witchey-Lakshmanan Declaration, Ex. 1018, ¶ 28; 12
Polli Deposition Transcript, Ex. 2072, 72:25-73:6; ’417 patent, Ex. 2017, 20:63–13
21:10). We further agree with Soll that each of the excipients is named specifically 14
in the Soll specifications. (SO1, Paper 167, 14:7-18:6). 15
However, when we review the Soll specifications, in view of the arguments 16
presented and evidence pointed out to us, we determine that Roepke has shown 17
that there is insufficient guidance to the specific combination claimed by Soll to 18
have conveyed possession thereof to one skilled in the art. While we agree that 19
fluralaner and each excipient are named within the Soll specifications, the evidence 20
shows that one skilled in the art would not been given direction sufficient to make 21
each selection, within the large number of options available, required to arrive at 22
the claimed subject matter. 23
For example, in addition to afoxolaner and fluralaner, the Soll specification 24
provides the “full chemical structure” of 43 other isoxazoline compounds, 25
17

designated Compounds 1.001-1.025 and 2.001-2.018. (Witchey-Lakshmanan 1
Deposition Transcript, Ex. 1026, 61:3-19.) While the Soll specification names 2
fluralaner, the specification does not state a preference for fluralaner over the other 3
disclosed isoxazoline compounds, leaving one to select between 45 disclosed 4
compounds as well as the numerous possible combination of excipients. (’417 5
patent, Ex. 2017, 7:14-19 and e.g., 44:39-45:18). 6
Regarding surfactant selection, we agree with Soll that SLS was a well 7
know surfactant, however, as with fluralaner and the other excipients of the claims, 8
the Soll specifications do not indicate a preference for, or other guidance that 9
would prompt the selection of, SLS. (Witchey-Lakshmanan Deposition Transcript, 10
Ex. 1026, 31:15-32:16; 97:25-98:12.) Instead, Dr. Witchey-Lakshmanan’s 11
testimony indicates that, for example, the Soll specifications teach a preference for 12
palatable surfactants over bitter ones and that SLS was known to have a bitter taste. 13
(Witchey-Lakshmanan Deposition Transcript, Ex. 1026, 95:12-96:8; 125:16-22.) 14
As another example, Dr. Witchey-Lakshmanan’s testimony indicates that a person 15
of ordinary skill in the art would have understood that only “specific 16
combinations” of excipients would be capable of obtaining the high bioavailability 17
desired by Soll, and Soll’s only disclosure of “specific combinations” for achieving 18
high bioavailability and long-term efficacy all use the active agent afoxolaner and 19
the surfactant PEG-hydroxystearate, not what is found in the Soll claims. 20
(Witchey-Lakshmanan Deposition Transcript, Ex. 1026, 305:22-307:6). 21
We have considered all the evidence and argument pointed out to us by each 22
party. We are convinced that there was insufficient guidance or “blazemarks” 23
within the Roepke specifications to amount to description of the particular claimed 24
composition and method. In re Ruschig, 379 F.2d at 995. Each specific 25
18

component of the claims is named within a larger list of component options. While 1
the number of options provided is significant if one skilled in the art would have 2
been guided to these specific components in the specific combination required by 3
the Soll involved claims, the invention would be described. Here that is not the 4
case and the evidence before us persuades us that one skilled in the art would not 5
have been able to “clearly conclude” that the Soll inventors invented what is 6
claimed. In re Alonso, 545 F.3d, at 1019. 7
Accordingly, we GRANT Roepke Motion 1 and determine that all of Soll’s 8
involved claims are unpatentable for lack of written description. As noted above 9
we have not considered Roepke Motion 1 to be a threshold motion. We exercise 10
our discretion to consider Soll Motions 2-4, each of which seeks judgment against 11
Roepke on the basis that the Roepke claims are unpatentable. 12
3. Soll Motion 2 13
In its Motion 2 Soll seeks judgment that the Roepke claims are unpatentable 14
for failing to provide sufficient written description for the claimed subject matter. 15
We DENY this motion. 16
As the moving party it is incumbent upon Soll to provide a full statement of 17
the reasons for the relief requested with a detailed explanation of the significance 18
of the evidence and the governing law. Bd.R. 121(c)(iii). It is not our role to take 19
Soll’s asserted facts, or any evidence cited therein, and show how they may 20
support Soll’s arguments nor would it be fair to the opposing party for us to do so. 21
In its Motion 2 argument Soll cites a long list of facts (“SMFs 1-44”, cited at SM2, 22
Paper 104, 19:12-13), without citing the underlying evidence supporting these 23
facts. Likewise Soll does not explain in particular why the facts or evidence 24
support its argument as required by our rules. For example, most all of Soll’s 25
19

argument, reproduced below, provides no citation at all to either its statement of 1
facts or evidence: 2
Roepke did not have possession of any composition that did not 3
include The Pamoic Acid / Salt Component. Accordingly, there is no 4
written description in any Roepke involved, benefit or lineage 5
application[13] for any formulation that does not include The Pamoic 6
Acid / Salt Component—rather, those applications disclose such 7
formulations are not processable. 8
There is likewise no dosage or efficacy information in any 9
Roepke involved, benefit or lineage application for any composition 10
that does not include The Pamoic Acid / Salt Component. There is 11
accordingly no written description in any Roepke involved, benefit or 12
lineage applications for the Count or any involved claim of the 13
Parties. Quite simply, the Roepke involved, benefit or lineage 14
applications inform a POSA that soft chew formulations that do not 15
contain The Pamoic Acid / Salt Component cannot be successfully 16
made. Thus, none of the Roepke involved, benefit or lineage 17
applications provide benefit or priority or a constructive reduction to 18
practice for the Count or any of the involved claim of the Parties, 19
since they cover formulations where The Pamoic Acid / Salt 20
Component is absent. See Curtis, Gentry, Hardin v. Williams. 21
Accordingly, Soll respectfully requests this Interference should be 22
terminated with Judgment in favor of Soll. 23
24
(SO2, Paper 104, 19:14-20:9). 25

13 Soll’s motion is for judgment on the basis of unpatentability for lack of
written description for the involved Roepke claims. We consider only whether the
involved Roepke specification sufficiently described the claims and do not
consider whether sufficient description was provided by any earlier filed Roepke
application.
20

In addition, Soll’s briefing does not comply with the Standing Order by 1
“mak[ing] all arguments accessible to readers, rather than ask them to play 2
archeologist with the record.” (SO, Paper 2, ¶106.2, citing DeSilva v. DiLeonardi, 3
181 F.3d 865, 866-67 (7th Cir 1999)), and requiring, in particular, that a party 4
referring to a numbered fact in its argument should also cite to the underlying 5
evidence. (Standing Order, Paper 2, ¶121.4.1). 6
For this reason alone Soll’s motion is deficient and is denied. 7
The motion is denied for the additional reason that we do not find 8
convincing Soll’s argument that Roepke only provides description for claims 9
where pamoic acid or salt thereof (PA component) is present. 10
The Roepke claims are directed to a solid soft chewable veterinary 11
composition effective for treating and/or controlling flea or tick infestation in an 12
animal that comprises fluralaner, PEG 3350 as a forming agent, SLS as a 13
surfactant, corn starch as a filler and glycerol as a humectant where the effect is 14
achieved based on the weight and type of animal and the composition is effective 15
for fleas or ticks by administration to the animal every 2 or 3 months. (Roepke 16
Clean Copy of Claims, Paper 9, 3). 17
Soll argues that the Roepke specification shows that a PA component is 18
required as a necessary or essential element of the Roepke invention such that the 19
Roepke specification does not support a formulation that does not require a PA 20
component. Soll asserts that Roepke essentially copied claims from Soll14 but that 21

14 The Roepke claims are not verbatim copies of the Soll claims and Soll does
not provide sufficient explanation for why it believes the claims were copied.
Further, since Soll has not explained, or provided evidence to show, that Roepke
first made an involved claim only after publication of the Soll application or
issuance of Soll’s patent, we do not consider Soll Motion 2 to raise a threshold
21

these copied claims do not require “pamoic acid, or a pharmaceutically acceptable 1
salt thereof that is not a pharmaceutically active ingredient”. According to Soll, 2
the Soll involved specifications have “only one mention of an active ingredient that 3
is a pamoate salt” and thus, “the involved claims of Roepke cannot be construed as 4
requiring any composition, either explicitly or implicitly, that contains the Pamoic 5
Acid / Salt Component”. (SM2, Paper 104, 19:5-11). 6
The Roepke claims are limited by the transitional phrase “comprising” and 7
therefore do not expressly exclude unlisted excipients. AFG Industries, Inc. v. 8
Cardinal IG Co., 239 F.3d 1239, 1244-45 (Fed. Cir. 2001). We understand it to be 9
Soll’s position though that we must construe Roepke’s claims as excluding an 10
“inactive” PA component because the Soll specification includes PA only as an 11
“active” ingredient. As Soll does not provide sufficient explanation, or direct us to 12
evidence sufficient to show, that the Roepke claims were “essentially copied”, we 13
do not find it necessary to consult the Soll specification to construe the Roepke 14
claims. Cf. Agilent, 567 F.3d at 1375. 15
We agree with Soll that the Roepke specification clearly indicates that the 16
inventors considered the inclusion of a PA component to be an inventive 17
contribution directed at improving processability when making soft chews in a 18
forming machine and the inclusion of a PA component is a focus of the 19
specification. The Roepke specification asserts that “[t]he use of pamoic acid or a 20
pharmaceutically acceptable salt thereof as an excipient in soft chew formulations 21
has not been described” and that the PA component is an important excipient to be 22
included so that the soft chews “can be easily processed in a forming machine” and 23

issue under Bd. R. 201. Even were this a threshold motion Roepke would not be
deprived of standing as we deny the motion.
22

to “facilitate[] manufacturing of such soft chews on an industrial scale using a 1
forming machine.” (Roepke ’924, Ex. 2006, 2:15-20). 2
The Roepke specification also provides that “[a]nother aspect of the current 3
invention” is a soft chew comprising an isoxazoline compound for use in 4
controlling parasitic insects of an animal. (Roepke ’924, Ex. 2006, 6:26-29). 5
In its Motion 2 argument, Soll does not address that portion of the Roepke 6
specification stating that the isoxazoline soft chews may be made by hand, which 7
does not require industrial scale manufacturing using a forming machine. In 8
particular the specification states: 9
Preferably, dry ingredients of the chew mixture are blended first; then 10
the liquid components (e.g., oil, humectants or solvents) are added and 11
blended therein to form a thoroughly blended mixture. After blending, 12
the soft chew mixture is discharged from a port through the blender 13
into a suitable container for processing into individual dosage unit by 14
hand or preferably with a forming machine. 15
16
(Roepke ’924, Ex. 2006, 25:15-19, emphasis added.) 17
The Roepke specification provides exemplary compositions that contain 18
fluralaner as an active ingredient, PEG 3350 as the forming agent, sodium lauryl 19
sulfate as the surfactant, glycerol as the humectant, and corn starch as the filler, as 20
well as additional excipients. Some are described as “[e]xamples of soft chews 21
that do not contain pamoic acid or salts or esters thereof”. While these 22
“comparative” example formulations cannot be processed on the forming machine 23
without the PA component, Soll does not explain, or provide evidence to show, 24
why the formulations do not provide sufficient description for the Roepke claims 25
as machine forming is not required by the claims. (Roepke ’924, Ex. 2006, 25:14-26
26:8; 28:1-32:4, 34:1-35:7). 27
23

We also note Soll’s argument that there is “no dosage or efficacy 1
information in any Roepke involved, benefit or lineage application for any 2
composition that does not include The Pamoic Acid / Salt Component”. The 3
Roepke specification states that “[t]he animals may receive a dosage every 2, 3, 4, 4
5 or 6 months” and provides exemplary data said to show tick efficacy of at least 5
58 days. (Second Polli Declaration, Ex. 2078, ¶23; Second Snyder Declaration, Ex. 6
2079, ¶¶27-30; Roepke ’924, Ex. 2006, 27:11-17, 36:1-37:10). As Soll notes the 7
exemplary formulation contains the claimed components as well as several other 8
excipients, including a PA component. However, Soll’s argument does not 9
explain, or direct us to evidence sufficient to show, why exclusion of the PA 10
component (or any other non-claimed excipient) would be expected to reduce 11
efficacy in a formulation that includes the active ingredient fluralaner. 12
Further we are convinced by testimony before us that one skilled in the art 13
would have recognized that the addition of an “inactive” PA component was not 14
for the purpose of providing flea and tick efficacy, which is the function of the 15
“active” fluralaner. (Second Polli Declaration, Ex. 2078, ¶ 52; Second Snyder 16
Declaration, Ex. 2079, at ¶¶27-31, 50-51). Instead the evidence before us shows 17
that one skilled in the art would have understood, from the Roepke specification, 18
that adding the PA component was an improvement to the claimed formulation so 19
that it could be produced on a commercial scale. Dr. Polli testified that, “[a] 20
person of ordinary skill in the art would also understand from typical practices and 21
the Roepke specification that after successful development of the formulation in 22
the lab”, it was found that processing of the formulation could be improved using 23
the PA component as a lubricant that could facilitate processing in certain forming 24
equipment on an industrial scale. (Second Polli Declaration, Ex. 2078, at ¶46). 25
24

Dr. Polli’s testimony is consistent with, and supportive of, the PA component not 1
being necessary for the soft chews to be effective. 2
We have considered the portions of the testimony pointed out to us by each 3
party in the briefing. Where the testimony diverges, we find the testimony of 4
Roepke witnesses Drs. Polli and Snyder to be more persuasive for at least the 5
reason that it appears that Dr. Witchey-Lakshmanan did not consider that the 6
Roepke specification states that soft chews could be formed by hand when forming 7
her initial opinion. (Witchey-Lakshmanan Deposition Transcript, Ex. 1017, 8
162:23-163:18). Moreover, Dr. Witchey-Lakshmanan’s testimony does not 9
convince us that one skilled in the art would have understood the PA component to 10
be necessary to the claimed efficacy when we weigh that testimony against the 11
testimony of Drs. Polli and Snyder discussed above. 12
While evidence before us indicates that the Roepke specification conveys 13
that a PA component must be included to allow for machine processing of the soft 14
chews, the involved Roepke claims do require that the soft chews be made in a 15
certain way, i.e., that they must be processable in a forming machine. The Roepke 16
specification instead expressly allows for hand forming the soft chews. Thus, based 17
on the evidence before us, we do not see this as a situation where what is described 18
as an essential element of the invention has been omitted from the claims as in 19
Gentry Gallery, i.e., “where the patent's disclosure makes crystal clear that a 20
particular (i.e., narrow) understanding of” the claim scope is the invention. That is, 21
we do not find the Roepke specification to “unambiguously limit[ ]” the Roepke 22
invention, as claimed, to only formulations that include a PA component. Johnson 23
Worldwide Assocs., Inc. v. Zebco Corp., 175 F.3d 985, 989–90 (Fed. Cir. 1999), 24
citing Gentry Gallery, Inc., 134 F.3d at 1480. 25
25

We determine that Soll has not met its burden of proof and we deny Soll 1
Motion 2. 2

D. Soll Motion 3 3
In its Motion 3, Soll seeks judgment against Roepke on the basis that the 4
Soll claims are not enabled by the Roepke specification. 5
We DENY this motion. 6
The written description requirement is separate and distinct from the 7
enablement requirement. Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 8
1341 (Fed. Cir. 2010). To satisfy the enablement requirement, the specification 9
must teach those skilled in the art how to make and use the full scope of the 10
claimed invention without requiring “undue experimentation”. In re Wright, 999 11
F.2d 1557, 1561, (Fed. Cir. 1993). “The determination of what level of 12
experimentation is ‘undue,’ so as to render a disclosure non-enabling, is made from 13
the viewpoint of persons experienced in the field of the invention.” Elan 14
Pharmaceutical, Inc. v. Mayo Foundation, 346 F.3d 1051, 1055 (Fed Cir. 2003). 15
Thus, as with written description, we consider the viewpoint of persons skilled in 16
the art in determining whether the disclosure is sufficiently enabling of the claimed 17
invention. Factors that are considered in the enablement inquiry include (1) the 18
quantity of experimentation necessary, (2) the amount of direction or guidance 19
presented, (3) the presence or absence of working examples, (4) the nature of the 20
invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) 21
the predictability or unpredictability of the art, and (8) the breadth of the claims. In 22
re Wands, 858 F.2d 731, 737 (Fed. Cir, 1988). 23
26

Soll argues that “[n]one of the Roepke applications[15]provides pre-AIA 35 1
USC § 112 ¶ 1 enablement for any of Roepke’s involved claims including because 2
those claims do not include The Pamoic Acid / Salt Component and there is 3
insufficient enablement as to how to make and use formulations not containing The 4
Pamoic Acid / Salt Component.” (SM3, Paper 105, 21:19-24). Soll further argues 5
that the Wands factors weigh against enablement because undue experimentation is 6
necessary to practice the claimed invention. In particular Soll argues that the 7
Roepke specification provides no direction or guidance to obtain a soft chew that 8
does not contain the PA component for an effective dosage to achieve efficacy for 9
a certain duration of time. (SM3, Paper 105, 18:11-21:17). 10
The issue raised by Soll is similar to that raised in its Motion 2 for judgment 11
on the basis that the Roepke claims lack written description support. In essence 12
Soll argues that the Roepke specification does not teach how to make and use the 13
claimed composition without the inclusion of the PA component. As with Soll’s 14
arguments in its Motion 2, we find the arguments Soll makes in its Motion 3 15
unpersuasive. 16
Soll points to examples 1 and 2 of the Roepke specification said to teach that 17
formulations having at least 1.5% w/w sodium pamoate are processable but those 18
containing 1.0% w/w sodium pamoate or no sodium pamoate are “not 19
processable.” Thus, argues Soll, one skilled in the art would understand that the 20
Roepke specification “do[es] not teach, disclose, or suggest that a uniform product 21

15 Soll’s motion is for judgment on the basis of unpatentability for lack of an
enabling disclosure for the involved Roepke claims. We consider only whether the
involved Roepke specification would have enabled these claims and do not
consider whether enablement was provided by any earlier filed Roepke application.
27

not containing [the PA component] can be obtained.” (SM3, Paper 105, 19: 4-7, 1
citing Witchey-Lakshmanan Declaration, Ex. 1001, ¶¶ 32, 35, 36, 38, 50). 2
But, as Roepke points out, its involved claims do not require processing at 3
any specified high throughput or at an industrial scale. (RO3, Paper 169, 2:13-16). 4
Soll does not provide evidence to show that one skilled in the art could not have 5
formed a soft chew that excludes a PA component without engaging in undue 6
experimentation. As noted in our discussion of Soll Motion 2, the Roepke 7
specification teaches that dosage forms can be made by hand for example (Roepke 8
’924, Ex. 2006, 25:15-19) and Dr. Witchey-Lakshamanan agreed. (Witchey-9
Lakshamanan Deposition Transcript, Ex. 1017, 162:23-163:18). 10
Further, as we noted above, Soll has not provided convincing evidence to 11
show that one skilled in the art would have considered that the exclusion of the PA 12
component would reduce efficacy in a formulation that includes the active 13
ingredient fluralaner. The testimony before us is convincing to show that one 14
skilled in the art would have recognized that the addition of an “inactive” PA 15
component was not for the purpose of providing flea and tick efficacy, which is the 16
function of the “active” fluralaner. (Second Polli Declaration, Ex. 2078, ¶ 52; 17
Second Snyder Declaration, Ex. 2079, ¶¶27-31, 50-51). 18
As above, we have considered the portions of the testimony pointed out to us 19
by each party in the briefing. Where the testimony diverges, we find the testimony 20
of Roepke witnesses Drs. Polli and Snyder to be more persuasive for at least the 21
reasons stated above with regard to written description. 22
Soll has not shown that undue experimentation would have been required to 23
make and use the claimed invention nor has Soll provided any other basis 24
28

sufficient to show a lack of enablement for the Roepke involved claims. 1
Accordingly, Soll has not met its burden of proof. 2
We deny Soll Motion 3. 3
4
E. Soll Motion 4 5
In its Motion 4 Soll seeks judgment that the Roepke claims are unpatentable 6
as indefinite under the second paragraph of 35 USC § 112. 7
We DENY this motion. 8
The second paragraph of 35 USC § 112 requires that the claims particularly 9
point out and distinctly claim the subject matter which the applicant regards as his 10
invention. 35 USC 112, ¶ 2. The definiteness of the claims is considered in view 11
of the specification and from the perspective of one skilled in the art. Amgen, Inc. 12
v. Chugai Pharm. Co., Ltd. 927 F.2d 1200, 1217 (Fed. Cir. 1991) (“A decision as 13
to whether a claim is invalid under this provision requires a determination whether 14
those skilled in the art would understand what is claimed.”); Personalized Media 15
Commc’ns, LLC v. Int’l Trade Comm’n, 161 F.3d 696, 705 (Fed. Cir. 1998). 16
The entire argument section of Soll Motion 4 is one paragraph in length and 17
is reproduced below: 18
1. Roepke’s Claims are Not What Roepke Regards as their “Invention”. 19
Pre-AIA 35 U.S.C. § 112, ¶ 2, states, “The specification shall 20
conclude with one or more claims particularly pointing out and 21
distinctly claiming the subject matter which the applicant regards as 22
his invention.” See also In re Zletz, 893 F.2d 319 (Fed Cir. 1989) 23
(“the inquiry . . . is patentability of the invention as ‘the applicant 24
regards’ it” (footnote citation to pre-AIA § 112, ¶ 2, omitted). 25
Objectively, when one compares the Count and each of Roepke’s 26
29

claims with Roepke’s involved, benefit and lineage applications[16], it 1
is apparent that the Count and any involved claim of Roepke are not 2
what the Roepke inventors regarded as their invention (see acts[sic] 5-3
26; Motion 4 at 2:15-9:7) and, thus, the Roepke applications and 4
involved claims do not comply with pre-AIA § 112, ¶ 2. See Allen 5
Eng’g Corp. v. Bartell Indus., Inc., 299 F.3d 1336 (Fed. Cir. 2002). 6
There is accordingly no constructive reduction to practice for the 7
Count or any involved claim of the Parties by any of Roepke’s 8
involved, benefit and lineage applications. This Interference should 9
be terminated with Judgment in favor of Soll, and such relief is 10
respectfully requested. 11
12
(Soll Motion 4, Paper 106, 17:12-18:2). 13
14
Soll’s argument does not provide an explanation of, or evidence to show, 15
why one skilled in the art would not have understood what is being claimed by 16
Roepke. While Soll refers us back to its facts “5-26”, this does not amount to a 17
detailed explanation of the significance of the evidence as required by our rules. 18
Bd. R. 121(c)(iii). As we have previously noted in this Decision, it is not our role 19
to take Soll’s asserted facts, or any evidence cited therein, and show how they may 20
support Soll’s arguments nor would it be fair to the opposing party for us to do so. 21
As Soll Motion 4 does not provide convincing argument of indefiniteness or 22
support its argument with persuasive evidence to justify the relief sought, we deny 23
the motion without need to consider Roepke Opposition 4. Bd. R 208(b). 24

16 Soll’s motion is for judgment on the basis of unpatentability due to
indefiniteness of the involved Roepke claims. We consider only whether the
involved Roepke claims are indefinite within the involved Roepke specification.
30

We also deny the motion for the additional reason that we do not find 1
convincing Soll’s position that the “involved claim[s] of Roepke are not what the 2
Roepke inventors regarded as their invention” which we understand to be based on 3
the failure of the Roepke claims to require a PA component. (SM4, Paper 106, 4
17:17-21). For reasons stated above we do not find convincing Soll’s argument 5
that one skilled in the art would have understood that the Roepke specification 6
limits the Roepke invention to soft chews requiring a PA component. 7
Soll has not met its burden of proof and we deny Soll Motion 4. 8
9
F. Other Motions 10
1. Roepke 11
Because we have determined that Soll’s claims are unpatentable for lack of 12
written description support we need not, and do not reach, Roepke Motion 2, for 13
judgment on the basis that the Soll claims are unpatentable on the basis of a lack of 14
lack of enablement (RM2, Paper 111), Roepke Motion 3 challenging Soll’s 15
accorded benefit (RM3, Paper 113), or Roepke Motion 4 seeking benefit (RM4, 16
Paper 112). Further we need not reach Roepke contingent Motion 5, a contingent 17
responsive motion seeking to add a claim to its involved application (RM5, Paper 18
141), since we do not grant any of Soll Motions 2-4 for judgment on the basis that 19
the Roepke claims are unpatentable. 20
In its Motion 6 Roepke moves to have the Board exclude the following 21
evidence offered by Soll: 22
The first Declaration of Dr. Leonore Witchey-Lakshmanan, Exhibit 1001; 23
The second Declaration of Dr. Leonore Witchey-Lakshmanan, Exhibit 1018; 24
31

A set of Tables 1-4 said to support Count 1 in the Soll specifications, 1
Exhibits 1007-1010 (set (“Tables 1-4”); and 2
A set of product information regarding Credelio, Cimilgex and Trocoxil, 3
Exhibits 1016, and 1021-1023. 4
We either have not relied upon this evidence in reaching our decision (Ex. 5
1007-1010, 1016, and 1021-1023) or, when we consider the evidence (Ex. 1001 6
and 1018), we would still grant Roepke Motion 1 and deny Soll Motions 2-4. 7
Accordingly, we DISMISS as moot Roepke Motion 6. 8
2. Soll 9
Because we have determined that Soll’s claims are unpatentable for lack of 10
written description support we need not, and do not, consider Soll Motion 1 11
challenging Roepke’s accorded benefit date (SM1, Paper 108). 12
13
III. Conclusion 14
Since we grant Roepke Motion 1, Soll has no patentable claims remaining in 15
either its involved patent or application. We enter judgment again Soll in a separate 16
paper. 17
18
IV. Order 19
It is 20
ORDERED that Roepke Motion 1 is GRANTED; 21
FURTHER ORDERED that Soll Motions 2, 3, and 4 are DENIED; 22
FURTHER ORDERED that Roepke Motion 2, 3, 4 and 5 and Soll Motion 1, 23
are DISMISSED as moot; and 24
32

FURTHER ORDERED that judgment will be entered against Soll in a 1
separate paper. 2

cc (via email):

Attorney for Roepke:
Janelle D. Waack, Esq.
R. Gregory Parker, Esq.
BASS, BERRY & SIMS PLC
jwaack@bassberry.com
gparker@bassberry.com

David J. Kerwick, Esq.
MERCK SHARP & DOHME CORP.
david.kerwick@merck.com

Raymond N. Nimrod, Esq.
Amanda K. Antons, Ph.D.
QUINN EMANUEL URQUHART & SULLIVAN, LLP
raynimrod@quinnemanuel.com
amandaantons@quinnemanuel.com

Attorney for Soll:
Dr. Judy Jarecki-Black, Esq.
Dr. John E. Ezcurra, P.A.
BOEHRINGER INGELHEIM ANIMAL HEALTH
Judy.Jarecki@Merial.com
John.Ezcurra@Merial.com

33

Blas P. Arroyo, Esq.
Matthew W. Howell, Esq.
ALSTON & BIRD LLP
Blas.Arroyo@Alston.com
Matthew.Howell@Alston.com