Ex Parte Berlin

Patent Trial and Appeal Board

May 31, 2013

11055338 (P.T.A.B. May. 31, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte ROGER G. BERLIN
__________

Appeal 2011-009313
Application 11/055,338
Technology Center 1600
__________

Before TONI R. SCHEINER, ULRIKE W. JENKS, and
GEORGIANNA W. BRADEN, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal
1
under 35 U.S.C. § 134 from the rejection of claims
21-36, directed to a pharmaceutical composition comprising ibuprofen and
phenylephrine. The claims have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1
Appellant identifies the Real Party-In-Interest as Wyeth, a company
incorporated in the State of Delaware (App. Br. 4).
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STATEMENT OF THE CASE
According to the present Specification:
[T]he addition of a non-steroidal anti-inflammatory agent to a
composition containing an antihistamine or a decongestant
enhances the efficacy of the antihistamine or decongestant, thus
permitting a reduction in the total dose of antihistamine or
decongestant. In particular, the amount of antihistamine or the
decongestant can be less than or equal to about 75 % of an
amount present in an approved dose of the decongestant or the
antihistamine relative to an amount of the NSAID
corresponding to about 100% of the amount present in a normal
strength dosage form of the NSAID. This combination . . .
results in an enhanced effect of the decongestant or
antihistamine . . . [and] provides the same or greater
symptomatic relief of rhinitis, including allergy, cold, cold-like,
and flu symptoms, as conventional products containing the
higher amounts of antihistamine and decongestants. This
discovery is particularly advantageous because lowering the
amounts of antihistamine or decongestant lowers the unwanted
side effects of each of these ingredients, such as the stimulatory
effect of decongestants, and the sedating effect of
antihistamines.
(Spec. 4: 2-16.)
Claims 21-36 are pending and on appeal. Appellant does not present
separate arguments for the claims. Therefore, we select claim 21 as
representative of the subject matter on appeal, and the remaining claims will
stand or fall accordingly. See 37 C.F.R § 41.37(c)(1)(vii).
Claim 21 is as follows:
21. A unit dosage form comprising as active agents 150 to 250
mg ibuprofen and less than or equal to 10 mg phenylephrine and which does
not comprise an antihistamine.
Claims 21-36 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Sims et al. (WO 92/17171, Oct. 15, 1992).
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ISSUE
Does the preponderance of the evidence of record support the
Examiner‟s conclusion that it would have been obvious for one of ordinary
skill in the art to combine ibuprofen and phenylephrine in a unit dosage
form, in the amounts required by claim 21, given Sims‟ disclosure?
FINDINGS OF FACT
The following findings of fact (FF) are supported by a preponderance
of the evidence of record.
1. According to the Specification,
The present invention is directed to a pharmaceutical
composition which includes an effective amount of each of a
non-steroidal anti-inflammatory drug (NSAID), [and] a
decongestant . . . wherein the effective amount of the
decongestant . . . is less than about 75 % of an amount present
in an approved dose of the decongestant . . . , relative to an
amount of the NSAID corresponding to about 100 % of the
amount present in a normal strength dosage form of the
NSAID.
(Spec. 3: 2-7.)
2. The Specification teaches that:
The non-steroidal anti-inflammatory drugs (NSAID's) for
use in the pharmaceutical compositions . . . of the present
invention may be selected from any of the following categories:
(1) The propionic acid derivatives;
(2) the acetic acid derivatives;
(3) The fenamic acid derivatives
(4) The biphenylcarboxylic acid derivatives;
(5) The oxicams, and
(6) Cox-2 inhibitors
(Spec. 7: 18-25).
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According to the Specification, “typical effective analgesic amounts
of NSAID's are about 100-500 mg diflunisal, about 25-100 mg zomepirac
sodium, about 50-450 mg ibuprofen, more preferably 100-250 mg ibuprofen,
about 125-500 mg naproxen, . . . [etc.]; however, greater or lesser amounts
may be employed if desired or necessary” (Spec. 8: 22-27).
3. Further according to the Specification, “[t]he decongestants for
use in the pharmaceutical compositions . . . of the present invention include,
but are not limited to, pseudoephedrine, phenylephedrine, [and]
phenylpropanolamine” (Spec. 7: 4-6), and “[t]he exact amount [of
decongestant] required will vary from subject to subject, depending on age,
general condition of the subject, the severity of the condition being treated,
and the particular active agent administered, and the like” (id. at 4: 24-5:2).
4. The Specification exemplifies the following pharmaceutical
compositions:

(Spec. 11).
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5. The Specification does not provide any data regarding the
effectiveness of any of the exemplified compositions.
6. Dr. Nikhil J. Parekh
2
declares, in relevant part:
The pending claims call for pharmaceutical compositions
comprising ibuprofen and a decongestant where the amount of
decongestant in the composition is less than or equal to about
75% less of an approved dose of the decongestant and the
ibuprofen potentiates the activity of the decongestant. The
combination of a 100% dose of ibuprofen with a reduced dose
of a decongestant results in an enhanced effect of the
decongestant, and provides the same or greater symptomatic
relief of rhinitis. Until the present invention, it was not known
that ibuprofen in combination with a decongestant would
potentiate the activity of the decongestant, thereby allowing less
decongestant to be used and achieving the same or greater
effect. Additionally, the present invention is more than an
optimization of dose ranges, but based upon this surprising
discovery that the combination of a NSAID and decongestant
allows less decongestant to be used and achieves the same or
greater relief of symptoms.
There are advantages of the claimed composition that
contains reduced amounts of decongestant. Decongestants are
stimulatory and may cause nervousness, restlessness and
insomnia, especially if taken at night. There is a need in the art
for effective relief from rhinitis symptoms with a reduction in
adverse side effects. The composition of the present claims
allows one to take less active with the same or greater result,
thus reducing the experienced side effects.
(Decl. ¶¶ 7, 8.)

2
Declaration of Dr. Nikhil J. Parekh (“Decl.”) dated December 17, 2007,
originally submitted January 7, 2008 under the provisions of 37 C.F.R. §
1.132, and resubmitted with Appellant‟s Reply Brief.
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7. Dr. Parekh‟s declaration does not provide any data regarding
the effectiveness of any compositions encompassed by Appellant‟s
Specification.
8. Sims discloses a “pharmaceutical composition[] for use in the
treatment of pain and inflammation and the relief of nasal congestion and
sinus pressure symptoms in a mammalian organism” (Sims 2: 21-24). The
composition comprises an “analgesically and anti-inflammatory effective
amount of (S)-ibuprofen” in combination with a “sympathomimetically
effective amount of at least one of the sympathomimetic amine[]
[decongestants] phenylephrine, phenylpropanolamine, pseudoephedrine,
oxymetazoline, ephinephrine, naphazoline, xylometazoline,
propylhexedrine, [and] levo-desoxyephedrine” (id. at 2: 1-5; 2: 26-3: 1).
9. According to Sims, “[a]n effective amount of (S)-ibuprofen . . .
for use in an unit dose composition of this invention may range from 50 to
800 mg (S)-ibuprofen” and “[t]he preferred amount . . . is about 100 to 400
mg” (Sims 6: 21-25). Further according to Sims, “[t]he amount of the
decongestant useful in the practice of the . . . invention may vary from about
1 mg to 100 mg depending on the specific decongestant” (id. at 7: 7-10).
10. Thus, the amounts of ibuprofen and phenylephrine required by
claim 21 (150-250 mg and ≤ 10 mg, respectively) are encompassed by the
ranges suggested by Sims for (S)-ibuprofen and decongestant, respectively
(see FF9).
PRINCIPLES OF LAW
“The law is replete with cases in which the difference between the
claimed invention and the prior art is some range or other variable within the
claims.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (citations
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omitted). “In cases involving overlapping ranges . . . even a slight overlap in
range establishes a prima facie case of obviousness.” In re Peterson, 315
F.3d 1325, 1329 (Fed. Cir. 2003). Moreover,
Selecting a narrow range from within a somewhat broader range
disclosed in a prior art reference is no less obvious than
identifying a range that simply overlaps a disclosed range. In
fact, when . . . the claimed ranges are completely encompassed
by the prior art, the conclusion is even more compelling than in
cases of mere overlap. . . . [A] prior art reference that discloses
a range encompassing a somewhat narrower claimed range is
sufficient to establish a prima facie case of obviousness.
(Id. at 1329-1330.)
“These cases have consistently held that in such a situation, the
applicant must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results relative to the
prior art range.” Woodruff, 919 F.2d at 1578.
The burden of demonstrating unexpected results rests on the party
asserting them. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). It is well
settled that results must be established by factual evidence. “Mere argument
or conclusory statements in the specification does not suffice.” In re De
Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). Finally, “„objective evidence
of nonobviousness must be commensurate in scope with the claims.‟” In re
Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990).
DISCUSSION
The Examiner finds that Sims discloses “a composition for pain and
inflammation comprising (S) ibuprofen and effective amount of at least one
[of] phenylephrine, pseudoephedrine or epinephrine” (Ans. 5). The
Examiner finds that Sims teaches that “[a]n effective amount of ibuprofen is
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. . . between 50 to 800 mg and preferably 100 to 400 mg,” while “[t]he
amount of decongestant varies from about 1 mg to 100 mg depending upon
specific decongestant” (id.).
The Examiner acknowledges that Sims “does not specifically
exemplify [a composition comprising] ibuprofen and phenylephrine” (id.),
but concludes that it would have been obvious “to choose phenylephrine
decongestant with an expectation to achieve similar results as . . . the art
equivalent pseudoephedrine decongestant which has been exemplified” (id.).
In addition, the Examiner finds that the required amounts of ibuprofen and
phenylephrine fall within the ranges disclosed by Sims for (S)-ibuprofen and
decongestant generally, and concludes that it would have been obvious, and
within the skill of the ordinary artisan, “to come up with workable ranges”
within the broader ranges disclosed by Sims (id. at 8-10).
We agree with the Examiner‟s conclusion that the composition of
claim 21 would have been obvious over Sims‟ disclosure. We are not
persuaded otherwise by Appellant‟s arguments.
Appellant contends that Sims “does not disclose and does not suggest
using phenylephrine” (App. Br. 12), and the Examiner “provides no
secondary reference or other evidence to support and sustain the conclusion
that phenylephrine is an „art equivalent‟ of pseudoephedrine” (id. at 13).
This argument is not persuasive, as Sims explicitly discloses both
phenylephrine and pseudoephedrine as suitable decongestants for its
compositions (FF8), even if pseudoephedrine is used in all Sims‟ working
examples. That is, Sims itself provides evidence to support the Examiner‟s
finding that phenylephrine and pseudoephedrine are “art equivalent” in the
context of Sims‟ disclosure. In any case, it is well settled that disclosed
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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 (CCPA 1971).
Appellant also argues that the particular amounts of ibuprofen and
phenylephrine required by the claims were “not obvious until applicant
discovered that ibuprofen would potentiate the activity of phenylephrine”
(Reply Br. 3), and that the particular amounts required by the claims provide
an “unexpected advantage . . . [in] that the decongestant amount may be
lowered to reduce side effects without loss of the desired decongestant effect
when phenylephrine is combined with ibuprofen” (id.).
We are not persuaded. The claimed amounts fall squarely within the
ranges suggested by Sims for (S)-ibuprofen and a decongestant in its unit
dose composition (FF9). It is well settled that selecting a narrow range from
a broader disclosed range is prima facie obvious, absent a demonstration that
the selected range is critical, generally by showing that the claimed range
achieves unexpected results. See Woodruff, 919 F.2d at 1578; Peterson, 315
F.3d at 1329-1330. However, the burden of demonstrating unexpected
results rests on the party asserting them, and must be established by factual
evidence. See e.g., Klosak, 455 F.2d at 1080. We have carefully reviewed
the Specification and the Declaration of Dr. Parekh, but find no data
regarding the effectiveness of any composition comprising an NSAID and a
decongestant (much less the claimed composition, which is not exemplified
in the Specification or in the Declaration), or any other factual basis for the
assertion that the properties of the claimed composition would have been
somehow surprising or unexpected to one of ordinary skill in the art. “Mere
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argument or conclusory statements in the specification does not suffice.” De
Blauwe, 736 F.2d at 705.
The preponderance of the evidence of record supports the Examiner‟s
conclusion that it would have been obvious for one of ordinary skill in the
art to combine ibuprofen and phenylephrine in a unit dosage form, in the
amounts required by claim 21, given Sims‟ disclosure.
SUMMARY
The rejection of claim 21 under 35 U.S.C. § 103(a) as unpatentable
over Sims is affirmed, and claims 22-36 fall accordingly, as they were not
separately argued.
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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