Ex Parte CHRISTOPH et al

Patent Trials and Appeals Board

Mar 26, 2019

13438410 - (D) (P.T.A.B. Mar. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/438,410 04/03/2012
27384 7590 03/26/2019
Briscoe, Kurt G.
Norris McLaughlin, PA
875 Third Avenue, 8th Floor
New York, NY 10022
FIRST NAMED INVENTOR
Thomas CHRISTOPH
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
106930.63521 us 2589
EXAMINER
MATOS NEGRON, TAINA DELMAR
ART UNIT PAPER NUMBER
1621
MAIL DATE DELIVERY MODE
03/26/2019 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JEAN DE VRY, THOMAS TZSCHENTKE,
PETRA BLOMS-FUNKE, KLAUS SCHIENE, and
MICHEL HAMON
Appeal 2018-000118
Application 13/438,410
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
RYAN H. FLAX, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeal from Examiner's
rejection of 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 Gruenenthal GMBH.
Appeal Br. 1.
Appeal 2018-000118
Application 13/438,410
STATEMENT OF THE CASE
Claims 1-3 and 5-9 are on appeal, and can be found in the Claims
Appendix of the Appeal Brief. Claim 1, the only independent claim, is
representative of the claims on appeal, and reads as follows:
1. A method of treating pain associated with a disorder
of the trigeminal nerve in a subject suffering therefrom, wherein
said disorder of the trigeminal nerve is selected from the group
consisting of trigeminal neuralgia and atypical facial pain, said
method comprising administering to said subject an effective
trigeminal pain alleviating amount of tapentadol, wherein the
tapentadol is administered orally, rectally, or parenterally.
Appellants request review of the Examiner's rejection of claims 1-3
and 5-9 under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Yeomans2
in view of Lange. 3
Examiner finds that Yeomans teaches treatment of trigeminal nerve
associated pain by administering analgesic agents, such as tapentadol. See
Ans. 3--4 (citing Yeomans Abstract, ,r,r 55, 103, 122, claims 1, 2, and 7).
Examiner acknowledges that Yeomans "does not specifically teach the
administration of tapentadol orally4 [ claim 1]; pharmaceutical dosage in the
form of a tablet [ claim 7] and wherein the tapentadol is administered in a
dosage amount of from 10 to 300 mg [claim 9]." Id. at 4. Examiner looks to
Lange for these teachings. Id. ( citing Lange ,r,r 27, 62, 79, 163, and 180).
Based on these combined teachings Examiner concludes that "one skilled in
the art would have reasonable expectation of success that tapentadol would
2 Yeomans et al., US 2010/0080797 Al, published Apr. 1, 2010
("Yeomans").
3 Lange et al., US 2009/0012180 Al, published Jan. 8, 2009 ("Lange").
4 We note that Examiner's rejection solely focuses on the oral route of
administration, even though only claim 3 is limited to that route.
2
Appeal 2018-000118
Application 13/438,410
treat trigeminal neuralgia and atypical facial pain based on it is analgesic
effects" when administered orally. Id. (citing In re Leshin, 227 F.2d 197
(CCPA 1960)). Because Lange teaches that tapentadol can be administered
via buccal as well as oral routes for the treatment of chronic pain, one of
skill in the art would have understood that based on those teaching
tapentadol would similarly treat trigeminal neuralgia and atypical facial pain
as well. See id. 4--5.
Appellants contend that Examiner applied an erroneous obviousness
standard (Appeal Br. 3-5), that Examiner relied on hindsight (id. at 5), that
Yeomans teaches away from oral administration (id. at 8-1 O; Reply Br. 2),
that Examiner wrongly equates buccal delivery with oral delivery (Appeal
Br. 6-8), and that the unexpected results presented in the Specification
overcome the alleged prima facie showing of obviousness (id. at 10-16).
We have reviewed Appellants' contentions that Examiner erred in
rejecting claims 1-3 and 5-9 are unpatentable over the combination of
Yeomans and Lange. We disagree with Appellants' contentions, and agree
with and adopt Examiner's findings concerning the scope and content of the
prior art with respect to oral administration, conclusion as well as response
to arguments as set forth in the Examiner's Answer and the Final Office
Action dated July 11, 2016. For emphasis, we highlight and address the
following:
We are not persuaded by Appellants' contention that Yeomans
teaches away from oral administration to "avoid systemic distribution."
Reply Br. 3; see also Appeal Br. 9 (Yeomans "expressly teach those of skill
to therefore avoid systemic distribution of an analgesic, which would be
achieved by oral administration."). To the contrary, Yeomans describes
3
Appeal 2018-000118
Application 13/438,410
systemic delivery, albeit through mucosal surfaces. Yeomans teaches in this
regard: "Using an intranasal or other mucosal route for systemic delivery of
a therapeutic agent allows for ease of administration and the ability to
bypass intestinal degradation and first pass hepatic metabolism of the
therapeutic agent." Yeomans ,r 16; see also ,r 19 ("administering to the
individual an effective amount of an analgesic agent wherein the
administration is targeted to the trigeminal nerve system and results
predominantly in analgesia to the facial or head region and wherein the
analgesic agent is administered via mucosal and/or dermal administration.").
Because application to mucosal membranes does not avoid systemic
distribution, we are not persuaded by Appellants contention that Yeomans
teaches away from oral administration.
Moreover, it is well settled that "in a section 103 inquiry, 'the fact that
a specific [embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered.'" Merck & Co. Inc. v. Biocraft Laboratories Inc., 87 4 F .2d 804,
807 (Fed. Cir. 1989) (quoting In re Lamberti, 545 F.2d 747, 750 (CCPA
1976)); see also In re Mills, 470 F.2d 649, 651 (CCPA 1972) ("All the
disclosures in a reference must be evaluated, including nonpreferred
embodiments, and a reference is not limited to the disclosure of specific
working examples" ( citations omitted).) In any case, it is well settled that
disclosed examples and preferred embodiments do not constitute a teaching
away from a broader disclosure or even non-preferred embodiments. See In
re Susi, 440 F .2d 442, 446 n.3 (CCP A 1971 ).
"Under the proper legal standard, a reference will teach away when it
suggests that the developments flowing from its disclosures are unlikely to
4
Appeal 2018-000118
Application 13/438,410
produce the objective of the applicant's invention. A statement that a
particular combination is not a preferred embodiment does not teach away
absent clear discouragement of that combination." Syntex (U.S.A.) LLC v.
Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005) (citations omitted).
Yeomans' recognition that targeted delivery may reduce the effective
dosage necessary to achieve analgesia, is not a teaching away from the
broader disclosure that the drug is effective for treating a pain, in this case
pain associated with trigeminal neuralgia and atypical facial pain.
In particular, buccal or sub lingual delivery can allow for targeted
delivery of an analgesic agent to the oral mucosa and to the
trigeminal divisions that innervate the oral mucosa to treat or
prevent trigeminal nerve-associated pain. Targeted delivery to a
trigeminal division can reduce the effective dosage necessary to
achieve analgesia in the facial or head regions wherein lower
effective dosages will further reduce CNS effects or systemic
side effects.
Yeomans ,r 83.
The observation in Yeomans that the mucosal route of administration
may reduce side effects to the central nervous system does not take away
from the broader teaching that tapentadol is a drug recognized to be effective
to treat trigeminal neuralgia and atypical facial pain. In other words, even if
reduction in central nervous system side effects is desirable, this would not
teach away from the use of tapentadol by a systemic route for treating pain,
including treating trigeminal neuralgia and atypical facial pain, particularly,
in view of Yeomans' teaching that intranasal administration can be used to
achieve systemic delivery. Yeomans ,r 16.
We are also not persuaded by Appellants' argument that Examiner
wrongly equates buccal delivery with oral delivery. See Appeal Br. 6-8.
Examiner acknowledges that Yeomans teaches buccal delivery, but does not
5
Appeal 2018-000118
Application 13/438,410
teach oral delivery. See Ans. 4. Examiner relies on Lange for teaching "that
tapentadol can be administer[ed via] oral or buccal" routes. Ans. 8.
Specifically, Examiner finds that Lange "demonstrates that tapentadol can
be administered in different forms ( orally or buccally) and be effective in the
treatment and management of pain conditions." Id. We find no error with
Examiner's reliance on Lange for teaching that tapentadol can be
administered via different routes to treat pain. It is based on this teaching in
Lange that Examiner concludes that oral administration and transmucosal
administration are obvious variants of each other. See id. We agree with
Examiner that the art sufficiently supports the position that oral and buccal
administration of tapentadol are each effective at treating pain, and thereby
sufficiently support Examiner's position that they are obvious variants of
each other. Accordingly, we are not persuaded by Appellants contention
that Examiner does not recognize that these are distinct routes of
administration.
Appellants contend that "tapentadol exhibits a dual mechanism of
action, on the one hand as a µ-opioid receptor agonist and on the other as a
noradrenaline transporter inhibitor ... [that] also contributes to its analgesic
efficacy." Appeal Br. 11. Appellants point to examples 2, 4, 5, and 9, and
figures 3, 5, 6, and 12 of the Specification as evidence of unexpected results
and the non-obviousness of the claims. See id.
We are not persuaded by Appellants unexpected results argument.
"[T]o properly evaluate whether a superior property was unexpected, the
[ fact finder must] consider[] what properties were expected." Pfizer, Inc. v.
Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007) (internal citation
omitted). As Examiner explains "the amounts of tapentadol administered [in
6
Appeal 2018-000118
Application 13/438,410
the Specification] overlap with the amounts taught in the prior art, which
establish effective amounts for the treatment of pain. Therefore, the effect
on pain with these amounts would not be unexpected." Ans. 10.
Specifically, Lang "taught administering 20 mg to 550 mg which overlap
with the instantly claimed amounts." Id. at 11. Additionally, Examiner
finds that "tapentadol at 10 mg/kg did not give far better or unexpected
results compared to [ for example to] morphine at the same dosage amount."
Id. We agree with Examiner that the evidence presented is not sufficient to
establish unexpected results for treating pain associated with trigeminal
neuralgia and atypical facial pain using tapentadol. We additionally note
that Appellants' reliance on an opioid different from tapentadol for
establishing unexpected results is not persuasive because it has not been
established that results with morphine or reboxetine can be extrapolated to
tapentadol. See Appeal Br. 14 (citing Figure 12A). On balance, we find that
evidence is insufficient to establish unexpected results based on a superior
property because tapentadol is already taught in the art to be effective for
treating pain.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 1 and Appellants have not
provided persuasive evidence to rebut the prima facie case. As Appellants
do not argue the claims separately, claims 2, 3, and 5-9 fall with claim 1.
37 C.F.R. § 41.37 (c)(l)(iv).
7
Appeal 2018-000118
Application 13/438,410
SUMMARY
We affirm the obviousness rejection over Yeomans and Lange.
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)(l)(iv).
AFFIRMED
8