Ex Parte Haas

Board of Patent Appeals and Interferences

Dec 16, 2010

11455964 (B.P.A.I. Dec. 16, 2010)

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.
11/455,964 06/19/2006 Ronald Thomas Haas RTH-2 2276
7590 12/16/2010
Eugene S. Indyk
366 Rue Road
Monroe Township, NJ 08831
EXAMINER
HAGOPIAN, CASEY SHEA
ART UNIT PAPER NUMBER
1617
MAIL DATE DELIVERY MODE
12/16/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte RONALD THOMAS HAAS
_________

Appeal 2010-008915
Application 11/455,964
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to an
aqueous ketoprofen solution. The Examiner has rejected the claims as

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-008915
Application 11/455,964

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anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.
STATEMENT OF THE CASE
Claims 1-17 are on appeal. Claim 1 is representative and reads as
follows:
1. A clear and stable aqueous solution, comprising a predetermined
therapeutically effective amount of an alkali metal salt of ketoprofen
dissolved in an aqueous medium.

The claims stand rejected as follows:
• Claims 1, 3-6, 10, 11, and 13-15 under 35 U.S.C. § 102(b) in view of
Allison;2
• Claims 1, 3, 13, and 14 under 35 U.S.C. § 102(b) in view of Osada;3
• Claim 2 under 35 U.S.C. § 102(b), or in the alternative under 35
U.S.C. § 103(a), in view of Allison;
• Claims 7-9 and 12 under 35 U.S.C. § 103(a) in view of Allison and
Pharmaceutical Excipients;4 and
• Claims 16 and 17 under 35 U.S.C. § 103(a) in view of Allison and
Mauskop.5

2 Allison, EP 0769294 A1, April 23, 1997.
3 Osada et al., JP 2001-031562A, Feb. 6, 2001 (citations refer to the certified
translation of record).
4 The Handbook of Pharmaceutical Excipients AMERICAN PHARMACEUTICAL
ASSOCIATION AND THE PHARMACEUTICAL SOCIETY OF GREAT BRITAIN,
pp. 123-124, 284-287 and 304-308 (1986).
5 Mauskop, US 5,914,129, June 22, 1999.
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I.
Issue
The Examiner has rejected claims 1, 3-6, 10, 11, and 13-15 as
anticipated by Allison. Claims 3 and 4 have each been argued separately;
claims 5, 6, 10, 11, and 13-15 stand or fall with claim 1.6 37 C.F.R.
§ 41.37(c)(1)(vii).
The Examiner finds that Allison discloses “an aqueous solution
comprising … naproxen, diclofenac, ketoprofen or ibuprofen” (Answer 3),
and also discloses a soluble salt of ketoprofen, preferably the potassium or
sodium salt, in the solution (id. at 4).
Appellant contends that Allison does not disclose an aqueous solution
that is clear and stable because “Allison describes a drink containing menthol
which is a waxy crystalline substance that is only slightly soluble in water
and gives off a strong odor” (Appeal Br. 4).7
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s finding that Alison discloses a ketoprofen-containing
aqueous solution that is clear and stable?

6 While claims 5, 6, 10, 11, and 13-15 are addressed separately in the Appeal
Brief (App. Br. 14), Appellant merely reiterates the arguments made with
respect to claim 1.
7 In the Reply Brief, Appellant cites two web pages as evidence that menthol
is volatile and insoluble in water (Reply Br. 2). However, new evidence
cannot be filed with a Reply Brief. See 37 C.F.R. § 41.33(d). We have not
considered the evidence newly submitted with the Reply Brief.
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Findings of Fact
1. Allison discloses “pharmaceutical compositions containing
ibuprofen, naproxen, diclofenac or ketoprofen having improved taste
characteristics in aqueous solution” (Allison, col. 1, ll. 2-6).
2. Allison discloses “an aqueous solution comprising a) … 20 to 300
mg of ketoprofen in the form of a soluble salt …; b) sufficient of a flavouring
agent to provide a pleasant flavour; and c) 1 to 50 mg menthol” (id. at col. 2,
ll. 29-41).
3. Allison discloses that the compositions “may comprise ketoprofen
… in the form of any pharmaceutically acceptable salt (preferably the
potassium or sodium salt, more preferably the sodium salt)” (id. at col. 2, ll.
52-56).
4. Allison discloses that its composition “may comprise any
pharmaceutically acceptable source of menthol…. These include
concentrated menthol or menthol flavour agents comprising menthol plus
carriers.” (Id. at col. 4, ll. 14-18.)
5. Allison exemplifies a composition that contains, among other
things, ibuprofen and menthol flavour BP (20% menthol, 80% carrier),
which was added to water to form a drink (id. at col. 6, ll. 5-53).
6. Allison exemplifies another composition in which the ibuprofen of
the composition in FF 5 was replaced with ketoprofen, which “has an
improved flavour when dissolved in hot water and compared to the same
formulation without menthol” (id. at col. 7, ll. 51-55).
Analysis
Claim 1 is directed to a “clear and stable aqueous solution” comprising
an alkali metal salt of ketoprofen. Allison discloses an aqueous solution
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comprising ketoprofen, preferably as the potassium or sodium salt. Appellant
argues, however, that Allison’s solution is not clear and stable because it
“contain[s] menthol which is a waxy crystalline substance that is only slightly
soluble in water and gives off a strong odor. The presence of menthol in the
Allison compositions creates liquids that are not clear due to the insolubility
of the menthol.” (Appeal Br. 4.)
Appellant’s arguments are not persuasive. Claim 1 does not recite any
particular standards of clarity or stability for the claimed composition, nor
does the Specification expressly define “clear” or “stable” to require a
specific level of clarity or stability. Appellant asserts that Allison’s
composition cannot be clear and stable due to the insolubility and volatility
of menthol, but Appellant has not pointed to evidence sufficient to support
his position that Allison’s aqueous solution would not have met the broadest
reasonable interpretation of a “clear and stable” solution, especially when
formulated with menthol combined with a carrier, as disclosed (FF 4). In
addition, Allison discloses an aqueous solution comprising ketoprofen
“without menthol” (FF 6, comparative formulation), and Appellant has not
proffered an adequate basis for concluding that that solution was not clear
and stable.
Appellant also argues that Allison does not disclose or suggest a
composition in which “there is no particulate matter evident in the solution
upon visual examination,” as required by claim 3, because Allison “refer[s]
to ingredients and manufacturing techniques that insure [sic] that particulate
matter will be evident in the finished product” (Appeal Br. 13).
This argument is not persuasive. As discussed above, Allison
discloses formulating its composition with menthol in combination with a
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carrier. Appellant has not pointed to sufficient evidence to support his
position that Allison’s composition would necessarily contain particulate
matter when formulated as disclosed by Allison.
Appellant argues that “Claim 4 specifies a composition in accordance
with claim 1, in which the flavor of ketoprofen has been reduced without
additional flavoring agents. This is directly contrary to the Allison
application which seeks to mask the flavor of ketoprofen with menthol and
other flavoring agents.” (Appeal Br. 13).
This argument is not persuasive. Claim 4 (as amended June 22, 2007)
is directed to a “palatable solution in accordance with claim 1, in which the
extremely bitter and burning taste of ketoprofen is substantially eliminated.”
Claim 4 does not preclude the addition of other flavoring agents, such as the
menthol and flavoring agents in Allison’s composition. Thus, Allison’s
composition meets the limitations recited in claim 4.
Conclusion of Law
The evidence of record supports the Examiner’s finding that Allison
discloses a ketoprofen-containing aqueous solution that is clear and stable.
II.
The Examiner has rejected claims 1, 3, 13, and 14 as anticipated by
Osada, on the basis that the claims are in product-by-process format and
therefore read on Osada’s composition (Answer 5).
Appellant argues, however, that Osada does not disclose the invention
of claim 1 because Osada discloses “a liquid preparation that contains an
anti-pyretic analgesic, such as ketoprofen, in a ‘non-dissociated’ state (i.e. in
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its acid form),” rather than a liquid preparation containing an alkali metal salt
of ketoprofen as required by claim 1 (Appeal Br. 12).
We agree with Appellant that the Examiner has not provided sufficient
basis for finding that claim 1 reads on Osada’s composition. Osada discloses
“a preparation for internal use that mitigates the disagreeable taste that
appears when taking antipyretic analgesics” (Osada ¶ 0001), including
ketoprofen (id. at ¶ 0010). Osada discloses that “sodium salts, potassium
salts, and magnesium salts block the disagreeable irritating taste” (id. at
¶ 0005). Thus, Osada discloses a liquid preparation that includes an
antipyretic analgesic (e.g., ketoprofen) together with sodium, potassium, or
magnesium salt(s) (id. at ¶¶ 0005-0007). Osada also discloses that the “pH is
preferably between 2.5-3.2. When the pH exceeds 3.2 the ratio of non-
dissociated molecules is smaller.” (id. at ¶ 0013).
Thus, Osada expressly discloses that the active agent (e.g., ketoprofen)
in its preparation is in the non-dissociated (acid) form. While the preparation
can also contain sodium or potassium salts, the Examiner has not adequately
established that Osada discloses a composition that comprises “an alkali
metal salt of ketoprofen dissolved in an aqueous medium” as required by
claim 1.
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631
(Fed. Cir. 1987). However, “[i]nherency may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient to establish inherency.”
Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999).
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Here, the Examiner has not shown that the limitations of claim 1 would
inherently be present in the composition disclosed by Osada. We therefore
reverse the rejection based on Osada.
III.
The Examiner has rejected claim 2 as anticipated by, or alternatively
obvious in view of, Allison. The Examiner concludes that Allison either
discloses or would have made obvious the unit dosage recited in claim 2
(Answer 6). We agree with the Examiner’s conclusion.
Appellant does not dispute the Examiner’s reasoning with regard to
the limitations added by claim 2, but again argues that Allison does not
disclose the invention of claim 1 (Appeal Br. 14-15).
This argument is not persuasive for the reasons discussed above.
IV.
The Examiner has rejected claims 7-9 and 12 as obvious in view of
Allison and Pharmaceutical Excipients, and has rejected claims 16 and 17 as
obvious in view of Allison and Mauskop. The Examiner concludes that the
dependent claims would have been obvious based on the teachings of the
cited references. We agree with the Examiner’s reasoning and conclusion.
With respect to these rejections, Appellant argues only that the
secondary references do not cure the deficiencies of Allison in suggesting the
invention of claim 1 (Appeal Br. 15-16).
This argument is not persuasive for the reasons discussed above.
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SUMMARY
We affirm the rejection of claims 1, 3-6, 10, 11, and 13-15 under 35
U.S.C. § 102(b) in view of Allison. We also affirm the rejection of claims 2,
7-9, 12, 16 and 17 under 35 U.S.C. § 103(a).
We reverse the rejection of claims 1, 3, 13, and 14 under 35 U.S.C.
§ 102(b) in view of Osada.
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

lp

EUGENE S. INDYK
366 RUE ROAD
MONROE TOWNSHIP NJ 08831