Ex Parte Lang et al

Patent Trial and Appeal Board

Jan 19, 2018

14183744 (P.T.A.B. Jan. 19, 2018)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/183,744 02/19/2014 Ingo LANG 01-1645-US-3 5086
28515 7590
C/O VP, IP, LEGAL
BOEHRINGERINGELHEIM USA CORPORATION
900 RIDGEBURY RD
P. O. BOX 3686
RIDGEFIELD, CT 06877-0368
EXAMINER
MAEWALL, SNIGDHA
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
01/23/2018 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
US PTO. e-Office .rdg @ boehringer-ingelheim .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte INGO LANG and IOANNIS PAPATSAS
Appeal 2017-005382
Application 14/183,744
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 submit this appeal under 35 U.S.C. § 134 involving
claims to methods of treating or preventing a respiratory disease in a pig.
The Examiner rejected the claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Boehringer Ingelheim
Vetmedica GmbH. App. Br. 3.
Appeal 2017-005382
Application 14/183,744
STATEMENT OF THE CASE
Appellants’ “invention relates to the use of meloxicam ... for
preparing a pharmaceutical composition for the treatment or prevention of
respiratory diseases in pigs.” Spec. 1:5—7.
The Specification explains that “[rjespiratory disease in pigs belongs
to the most important health problems in swine production.” Id. at 1:10—11.
According to the Specification, “[cjurrent therapy of porcine respiratory
disease includes treatment with antibiotics,” including “P-lactams” and
“tetracyclines.” Id. at 1:22—24. The Specification states that “[i]t is known
that cyclooxygenase-2 (COX-2) plays a relevant role in the pathophysiology
of porcine pleuropneumonia caused by Actinobacillus pleuropneumoniae,”
and describes studies showing “increased COX-2 expression in lungs of pigs
naturally infected with Actinobacillus pleuropneumoniae. ” Id. at 1:2 8—2:8.
The Specification further states that “[mjeloxicam is a non-steroidal anti­
inflammatory compound that belongs to the oxicam class and exerts potent
anti-inflammatory, anti-exudative, and anti-pyretic activity.” Id. at 2:28—29.
The Specification explains that “use of meloxicam in conjunction with
antibiotics in bovine respiratory disease is well-established” but states that
“to date no information on the use of meloxicam in pigs with respiratory
disease is publicly available.” Id. at 3:10-15.
Claims 1—8 and 11—24 on appeal. Claim 1 is illustrative:
1. A method of treating or preventing a respiratory disease
in a pig, the method comprising administering to a pig suffering
from a respiratory disease an effective amount of meloxicam or
a pharmaceutically acceptable salt thereof and an antibiotic.
App. Br. 15 (Claims App.).
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Application 14/183,744
The claims stand rejected as follows:
I. Claims 1—8 and 11—22 under 35 U.S.C. § 103(a) as obvious
over Freehauf,2 Shapiro,3 and Isakson.4
II. Claims 23 and 24 under 35 U.S.C. § 103(a) as obvious over
Freehauf, Shapiro, Isakson, and Larson.5
I
Issue
Does the preponderance of the evidence on this record support the
Examiner’s conclusion that claims 1—8 and 11—22 would have been obvious
over Freehauf, Shapiro, and Isakson?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 2—8 of the Final Rejection mailed Mar. 10, 2016 (“Final
Act.”). See also Ans. 2—8. We provide the following findings for emphasis
and convenient reference.
FF 1. Freehauf “relates to a composition containing an antibiotic for
use in the treatment of bacterial infections in animals such as cattle, sheep
and swine.” Freehauf 12. Freehauf teaches “formulations containing a
fluorinated chloramphenicol or thiamphenicol derivative antibiotic such as
florfenicol, and . . . using such formulations in the treatment and prevention
2 Freehauf et al., US 2012/0077764 Al, published Mar. 29, 2012.
3 Shapiro, US 2008/0234380 Al, published Sept. 25, 2008.
4 Isakson et al., US 5,700,816, issued Dec. 23, 1997.
5 Larson et al., US 6,180,136 Bl, issued Jan. 30, 2001.
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of infectious diseases in bovines and swine [e.g., pigs] including bovine
respiratory disease.” Id. Abstract; see also id. 1116, 40.
FF 2. Freehauf teaches that “swine respiratory disease (SRD) also has
a multifactorial etiology,” and that “[bjacterial infections caused by P.
multicoda . . . , Actinobacillus pleuropneumonia,” and other bacteria “may
result in respiratory disease in swine.” Id. 19; see also id. 110 (“Any of the
pathogens listed as possibly implicated in . . . SRD may stimulate excessive
inflammatory process in the lungs by producing various toxins that stimulate
the release of various cytokines, which up-regulate the inflammatory
process, resulting in death or morbidity.”); see also id. 115 (“[controlling
the infection and reducing inflammation will reduce the pyrexia [fever], thus
increasing the potential for recovery.”)
FF 3. Freehauf teaches “other active ingredients may be combined
with the formulations . . ., for example, anti-inflammatory agents such as
corticosteroids, NSAIDS, such as fhmixin, COX-inhibitors and other
analgesics.” Id. 1 62. Freehauf further teaches “[i]t may also be preferred to
employ a second antibiotic in the formulation,” and identifies tetracycline, P-
lactams, and tilmicosin as among the preferred antibiotics. Id.
FF 4. Shapiro relates to compositions for treatment of chronic
inflammatory diseases. Shapiro, Abstract. Shapiro teaches the compositions
are intended for treatment of inflammatory diseases in various animal
species, including dogs, cattle, and pigs. Id. 1218. Shapiro teaches
compositions including a primary agent, and co-agents, among which
Shapiro identifies antibiotics like tetracycline and NSAIDs, like meloxicam
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for systemic administration. Id. 1212. Shapiro teaches “(d') meloxicam,
dosage range from 0.1 mg/kg daily to 50 mg/kg daily.” Id. 1930.
FF 5. Isakson relates to compositions including a COX-2 inhibitor
and a leukotriene A4 inhibitor for the treatment of inflammation and
inflammation-related disorders. Isakson, Abstract; see also id. at 4:9—18.
Isakson teaches use of therapeutically-effective dosages of meloxicam as a
suitable COX-2 inhibitor. Id. at 2:65—3:2; see also id. 37:1—5 (claim 1) and
35:23—38 (dosage ranges). Isakson further teaches the “compounds are also
useful for treatment of mammals, including horses, dogs, cats,. . . pigs, etc.”
Id. at 4:6—8.
Analysis
Claim 1
The Examiner finds that Freehauf teaches or suggests the treating or
preventing respiratory disease in pigs by administering compounds including
antibiotics and other agents, like NSAIDs and COX inhibitors. Final Act. 2—
3. The Examiner finds, however, that Freehauf “does not exemplify
treatment of respiratory disease in pigs by using a specific NS AID,
meloxicam.” Id. at 3. So, the Examiner turns to Shapiro and Isakson.
The Examiner finds that Shapiro teaches treatment of inflammatory
diseases in animals, including in pigs, with compositions including
meloxicam in a dosage of between 0.1—50 mg/kg per day. Id. The
Examiner further finds that Shapiro teaches the antibiotic tetracycline may
be used, and that Shapiro provides a suitable dosage range. Id. The
Examiner finds Isakson “discloses treatment of inflammation and
inflammation-related disorders with a combination of cyclooxygenase-2
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inhibitor such as meloxicam and a hydroxylase inhibitor.” Id. The
Examiner notes Isakson’s teaching that pigs and other animals may be
treated with the composition. Id.
The Examiner concludes claim 1 would have been obvious. The
Examiner reasons it would have been obvious to have used meloxicam and
an antibiotic as taught by Shapiro and Isakson in combination with
Freehauf’s composition, including antibiotics like tetracycline and
florfenicoles, to treat respiratory disease in pigs. Id. at 4. According to the
Examiner, “Freehauf teaches that florfenicoles [antibiotics] are used to treat
respiratory disease in pigs and bovine and suggests NS AID [a category that
would include the NSAID/COX-2 inhibitor meloxicam] can be used.” Id.
“The expected result,” the Examiner determines, “will be use of cox-
inhibitor, meloxicam in combination with tetracycline and florfenicoles to
treat respiratory diseases in pigs.” Id.
We agree with the Examiner’s conclusion of obviousness on this
record. Freehauf teaches compositions that include one or more antibiotics
may be used to treat respiratory diseases in pigs, and further teaches
NSAIDs may be included. FF 1—3. Indeed, Freehauf further explains that
inflammation secondary to respiratory infection is common and can be
deadly, thus suggesting the desirability of adding an anti-inflammatory agent
like an NSAID. FF 2. Although Freehauf does not expressly disclose
meloxicam as an NS ATP/COX-2 inhibitor, that deficiency is made up by
Shapiro and Isakson, which teach the use of meloxicam (in appropriate
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doses) for treating inflammation in animals such as pigs. FF 4—5.6 The
Examiner’s combination here is little “more than the predictable use of prior
art elements according to their established functions.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 417 (2007). And, the dosage ranges for
meloxicam recited in Shapiro, for example, overlap with the ranges recited
in Appellants’ dependent claims. See App. Br. 15 (claims 4 and 5); FF 4. In
re Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003).
Below we address Appellants’ arguments.
Appellants argue there “is no express or implied disclosure by
Freehauf of utilizing meloxicam as an anti-inflammatory NSAID,” and that
Shapiro and Isakson fail “to teach or suggest the features of administering
meloxicam . . . and an antibiotic to a pig suffering from a respiratory
disease.” App. Br. 8; see also id. 9-11; Reply Br. 2—3.7 This fails to grapple
6 While we do not rely on this evidence, Appellants’ Specification admits it
was known to use antibiotics in combination with meloxicam to treat bovine
respiratory disease. Spec. 3:10-15. Even if no information was available
with respect to treating pigs with that combined therapy, as the Specification
asserts, the cited references and knowledge in the art would, at minimum,
provide a reason to try that therapy on pigs with a reasonable expectation of
success. “[T]he expectation of success need only be reasonable, not
absolute.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364 (Fed. Cir. 2007).
An antibiotic like tetracycline alone would be expected to provide some
treatment (see, e.g., Spec. 1:23—24) and, as the art like Shapiro and Isakson
suggests, meloxicam would be expected to provide at least some treatment
of inflammation arising from the respiratory infection. FF 4—5. Appellants’
Specification even acknowledges as background that meloxicam “exerts
potent anti-inflammatory, anti-exudative, and anti-pyretic activity.” Spec.
2:28-29.
7 Appellants contend in reply that meloxicam is a co-agent in Shapiro, which
is in combination with a “primary agent” in Shapiro. Reply Br. 3. This
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adequately or persuasively with the Examiner’s rejection, which is based on
obviousness and the combined teachings of the references. Arguing the
teachings of the references individually does not rebut the Examiner’s
rejection relying on the references in combination. In re Merck & Co., 800
F.2d 1091, 1097 (Fed. Cir. 1986). Nor are we persuaded the Examiner relies
on improper hindsight as Appellants contend. App. Br. 9, 11. Meloxicam is
a known NS AID/COX-2 inhibitor for treating inflammation as evidenced by
Shapiro and Isakson (FF 4—5), and the skilled person would have predictably
used it in combination with Freehauf, which lists NSAIDs and COX-
inhibitors as active agents that can be added and suggests treatment of
inflammation would also be desirable when combatting a respiratory
infection. FF 2—3.
Appellants next argue the Examiner is simply picking elements from
the references when convenient when the references are “focused on”
different things. App. Br. 10-11. For example, Appellants argue “Freehauf
is clearly focused on compositions comprising fluorinated chloramphenicol
or a thiamphenicol derivative antibiotic such as florfenicol and not the use of
meloxicam for treating animals.” Id. at 10. A prior art reference’s teachings
contention is unpersuasive for two reasons. First, Appellant does not show
that any alleged “primary agent,” assuming it needed to be included, would
have been excluded from the scope of claim 1, which is open-ended and
permits use of additional compounds. Second, the Examiner’s combination
does not require that each agent of Shapiro and Isakson be included in
Freehauf’s composition. In re Keller, 642 F.2d 413, 425 (CCPA 1981)
(holding “[t]he test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the structure of the
primary reference”).
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are not limited to what it is allegedly “focused on.” Cf. Merck & Co. Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (holding that
preferred and unpreferred embodiments must be considered). All of the art’s
teachings must be considered and here, as explained above, Freehauf teaches
NSAIDs and other agents (e.g. other antibiotics) may be used. FF 1—3.
Absent evidence to the contrary, it would have been obvious for the skilled
person to have selected a well-known and potent NSAID/COX-2 inhibitor
like meloxicam. FF 4—5; Spec. 2:28—29.
For the reasons above, the preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over Freehauf,
Shapiro, and Isakson. Claims 2—8, 11—14, and 17—22 were not separately
argued and fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
Claims 15 and 16
Claims 15 and 16 depend from claims 1 and 2 respectively and add
that “the disease is Porcine Respiratory Disease Complex and the pig is a
growing or fattening pig.” App. Br. 16. Appellants contend there is “no
teaching or suggestion of this feature by any of Freehauf, Shapiro and
Isakson.” Id. at 12.
We disagree. As an initial matter, to comply with our rules, separate
argument regarding claims must be provided as follows: “[ujnder each
heading identifying the ground of rejection being contested, any claim(s)
argued separately or as a subgroup shall be argued under a separate
subheading that identifies the claim(s) by number.” 37 C.F.R.
§ 41.37(c)(l)(iv). Appellants did not follow this rule. But even considering
Appellants’ argument, we find it unpersuasive. As the Examiner pointed
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out, the dosage ranges of claimed active agents (antibiotic and meloxicam)
and the dosages of those agents in the prior art overlap, thus suggesting the
Examiner’s modified composition would treat Porcine Respiratory Disease
Complex. Ans. 7—8. Appellants produced no evidence otherwise. As to
whether the pig is growing or fattening, when is that not the case with pigs
raised as livestock, which is clearly the population of animals being treated
in Freehauf? See, e.g., Freehauf 2, 4, 5, 9. In any event, it would be
obvious to treat pigs that are growing or fattening, and that contract the
respiratory disease, with Freehauf’s composition, as modified by the
Examiner to include meloxicam.
Conclusion of Law
The preponderance of the evidence supports the Examiner’s
conclusion that claims 1—8 and 11—22 would have been obvious over
Freehauf, Shapiro, and Isakson.
II
Issue
Does the preponderance of the evidence on this record support the
Examiner’s conclusion that claims 23 and 24 would have been obvious over
Freehauf, Shapiro, Isakson, and Larson?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 8—9 of the Final Rejection. See also Ans. 8—9. The
following findings are provided for emphasis and convenient reference.
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FF 6. Larson relates to “compositions and methods [that] are useful
for treating respiratory diseases, infections, inflammation, and pain in a
variety of animals.” Larson, Abstract. Larson teaches the disease may be
respiratory disease, and identifies pigs (porcine) as a variety of animals
treated. Id. at 6:14—37; see also id. 21:35—22:11 (claims 42, 44, 49, 51).
FF 7. Larson teaches the active agent of the composition may include
antibiotics, such as a tetracycline (e.g., oxytetracycline), a floroquinolone,
tilmicosin, and other compounds. Id. at 5:6—14, 6:14—22; see also id. 20:26—
31 (claims 13—15) and 21:35—22:11 (claims 42, 44, 51).
Analysis
Claims 23 depends from claim 1, and adds that the method is free
from administering a macrolide or a fenicole to the pig during administration
to the meloxicam. App. Br. 17. In other words, claim 23 excludes
administering certain antibiotics like tilmicosin (a macrolide) or florfenicol.
Claim 24 is an independent claim and, like claim 1, relates to a method of
treating or preventing a respiratory disease in a pig. Id. Claim 24 requires
administration of an effective amount of meloxicam and administration of an
antibiotic selected from P-lactams, quinolones, tetracyclines, sulfonamides,
and combinations thereof. Like claim 23, claim 24 excludes administering a
macrolide or fenicole.
The Examiner states that Freehauf “does not teach use of
oxytetracycline or tilmicosin, antibiotics.” Final Act. 8. We assume the
Examiner meant that Freehauf does not teach the use of these antibiotics to
the exclusion of, or as an alternative to, florfenicol. If not, the Examiner was
mistaken as Freehauf clearly teaches other antibiotics may be used,
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including oxytetracycline and tilmicosin. FF 3; Freehauf | 62. The
Examiner finds Larson teaches using several antibiotics to treat respiratory
disease in cattle and pigs, and concludes it would have been obvious “to
employ the oxytetracycline or tilmicosin of Larson et al. with the meloxicam
. . . and substitute [e.g., oxytetracycline] in place of Florfenicole in order to
treat respiratory diseases.” Final Act. 8—9. According to the Examiner, it
would have been obvious “to substitute one known ingredient, an antibiotic
with another known antibiotic ingredient with an expectation of obtaining
predictable results.” Id. at 9.
Appellants argue “[t]his is an unreasonable modification of the
teachings of Freehauf solely for the purposes of alleging claims 23 and 24
are obvious.” App. Br. 13. According to Appellants, the whole focus of
Freehauf is novel formulations comprising a florfenicol, and thus the skilled
person would not replace that agent with another antibiotic like a
tetracycline. And, Appellants contend, there is no evidence that using
oxytetracycline would have the same benefit as florfenicol in preventing
infectious disease in swine. Id. at 14.
The preponderance of the evidence favors the Examiner here. Larson
provides evidentiary support for the notion that oxytetracycline would
provide treatment of respiratory disease in pigs (FF 6—7), and thus would be
recognized by a skilled person as an alternative antibiotic to the florfenicol
that is the focus of Freehauf. Importantly, obviousness does not require that
oxytetracycline provide a better, or even the same level of benefit as
florfenicol. In re Mouttet, 686 F.3d 1322, 1334 (Fed. Cir. 2012) (“[J]ust
because better alternatives exist in the prior art does not mean that an
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inferior combination is inapt for obviousness purposes.”). A particular
combination or modification of the art may produce an inferior product or
method, yet be obvious still. Put differently, the skilled person considering
Freehauf and Larson may well have expected that removing florfenicol in
favor of oxytetracyline would provide a less effective treatment of
respiratory disease. But that does not mean that the substitution is
nonobvious, when the art shows that the compounds are known antibiotics
that each treat respiratory disease in pigs. And, regardless of the substitution
of the antibiotic, the reason for including meloxicam as an anti-inflammatory
agent would remain for reasons explained above.
Conclusion of Law
The preponderance of the evidence on this record supports the
Examiner’s conclusion that claims 23 and 24 would have been obvious over
Freehauf, Shapiro, Isakson, and Larson.
SUMMARY
We affirm the obviousness rejections on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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