Ex Parte Lemmens et al

Patent Trial and Appeal Board

Jun 27, 2013

10678082 (P.T.A.B. Jun. 27, 2013)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
10/678,082 10/06/2003 Jacobus M. Lemmens 091856-0105 4414
22428 7590 06/28/2013
FOLEY AND LARDNER LLP
SUITE 500
3000 K STREET NW
WASHINGTON, DC 20007
EXAMINER
SIMMONS, CHRIS E
ART UNIT PAPER NUMBER
1629
MAIL DATE DELIVERY MODE
06/28/2013 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 JACOBUS M. LEMMENS,
THEODORUS H.A. PETERS, FRANTISEK PICHA,
JOHANNES J. PLATTEEUW, and FRANS VAN DALEN
__________

Appeal 2012-001448
Application 10/678,082
Technology Center 1600
__________

Before TONI R. SCHEINER, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 51-59. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.

1 The Real Party in Interest is Noven Therapeutics, LLC (App. Br. 3). Note
that all references to the Appeal Brief (“App. Br.”) are to the “Substitute
Brief on Appeal” dated December 7, 2010.
Appeal 2012-001448
Application 10/678,082

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STATEMENT OF THE CASE
Claim 51 is representative of the claims on appeal, and reads as
follows (emphasis added):
51. A pharmaceutical composition comprising a sulfonate salt of
paroxetine, calcium hydrogen phosphate anhydrate in the form of plate
shaped crystals or agglomerates thereof, a disintegrant and a lubricant,
wherein said composition does not contain lactose or microcrystalline
cellulose, and wherein said composition has a pH within the range of 5.0 to
6.0.

The following ground of rejection is before us for review:
Claims 51-59 stand rejected under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Pathak,2 Benneker,3 and Chu.4 As
Appellants do not argue the claims separately, we focus our analysis on
claim 51, and claims 52-59 stand or fall with that claim. 37 C.F.R.
§ 41.37(c)(1)(vii).

ANALYSIS
The issue in this appeal is whether the preponderance of the evidence
of record supports the Examiner’s conclusion that the combination of
Pathak, Benneker, and Chu renders obvious a paroxetine pharmaceutical
composition wherein the pH of the composition is within the range of 5.0 to
6.0.
The Examiner finds that Pathak teaches formulation of paroxetine for
oral administration (Ans. 5). The Examiner finds further that Pathak teaches

2 Pathak et al., US 6,113,944, issued September 5, 2000.
3 Benneker et al., US 5,874,447, issued February 23, 1999.
4 Chu, US 4,675,188, issued June 23, 1987.
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the use of dicalcium phosphate dihydrates, but does not teach the use of
calcium hydrogen phosphate anhydrate in the form of plate shaped crystals
or agglomerates thereof (id.). The Examiner also notes that Pathak does not
teach the use of sulfonate salts of paroxetine (id.).
The Examiner relies on Benneker for teaching paroxetine sulfonate
salts (id.).
The Examiner then relies on Chu for teaching that “thermally
dehydrated dicalcium phosphates are preferred for use in direct compression
tableting because they provide increased compressibility” (id. at 6).
According to the Examiner, Chu teaches that differences in pH can affect the
shape and the size of the dehydrated dicalcium phosphate crystals (id.). The
Examiner also finds that Chu teaches that when boiling the crystals, the pH
can range from 3 to 7, and while dehydration can cause the pH to drop, it
can be neutralized after anhydrous formation (id. (citing Chu, col. 3, ll. 42-
48)).
Specifically, Chu teaches:
The porous anhydrous dicalcium phosphate can also be
prepared by boiling a dicalcium phosphate dihydrate. Boiling
can be conducting at pH’s ranging from neutral to about 3.
Dehydration will cause a drop in pH of from 1 to 2 pH units.
The pH can be neutralized after anhydrous formation with a
base, calcium bases such as lime being preferred.

(Chu, col. 3, ll. 42-48.)
The Examiner concludes that it would have been obvious to use
thermally dehydrated dicalcium phosphate as taught by Chu in place of the
dicalcium phosphate dehydrates of Pathak to provide increased
compressibility (Ans. 6). As the recited pH values, the Examiner notes that
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4
specific pH values are not provided by the references. The Examiner
concludes, however, citing In re Boesch, 617 F.2d 272, 276 (CCPA 1980)
and In re Aller, 220 F.2d 454, 456 (CCPA 1955), that it would have been
prima facie obvious to determine optimum values by routine
experimentation to “arrive at those pH values providing optimal
performance for a particular given pharmaceutical formulation” (id. at 6-7).
Appellants argue that the pH taught by Chu is for the reaction medium
from which anhydrous dicalcium phosphate is isolated, and not any resulting
calcium hydrogen phosphate product (App. Br. 10-11). Thus, Appellants
assert, because Chu fails to disclose the pH of its anhydrous dicalcium
phosphate, there is no expectation that the product will have a given pH (id.
at 11). Appellants assert further that even if Chu did disclose the pH of its
calcium hydrogen phosphate product, “there still remains no reasonable
expectation that a composition comprising Chu’s [calcium hydrogen
phosphate] product together with an active agent and other excipients would
have a pH of 5.0 to 6.0, as prescribed by the rejected claims” (id.).
Appellants thus argue that none of the references, including Chu,
“gives the skilled artisan a reason to adjust pH of dicalcium phosphate,
teaches how to adjust pH, or indicates what pH might pertain to a
composition that contains dicalcium phosphate of a given pH” (id. at 11-12).
That is, Appellants assert, none or the prior art relied upon by the Examiner,
either alone or in combination, “teaches or suggests a composition having
pH within the range 5.0 to 6.0, as claimed” (id. at 12).
Appellants’ arguments are not convincing. The Supreme Court has
emphasized that “the [obviousness] analysis need not seek out precise
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teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR Int’l v. Teleflex Inc., 550 U.S.
398. 418 (2007); see also id. at 421 (“A person of ordinary skill is also a
person of ordinary creativity, not an automaton.”). “If a person of ordinary
skill can implement a predictable variation, § 103 likely bars its
patentability.” (Id.)
In this case, we agree with Appellants (App. Br. 12) that the Examiner
has not established that the claimed composition would inherently have a pH
of 5.0 to 6.0. “Inherency . . . 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.” MEHL/Biophile Int'l. Corp. v.
Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999), quoting In re Oelrich,
666 F.2d 578, 581 (CCPA 1981).
We further agree with Appellants that Chu discusses pH in the context
of preparing anhydrous dicalcium phosphate. We do not agree, however,
that Chu does not teach adjusting the pH of its calcium hydrogen phosphate
product, as Chu specifically teaches that the pH can be neutralized after
anyhydrous formation.
And even though Chu, either alone, or as combined with Pathak and
Benneker, may not teach a pH of the final composition, we agree with the
Examiner that in the absence of evidence to the otherwise, it would been
obvious and well within the level of skill of the ordinary artisan to optimize
the pH of the composition to obtain those pH values providing optimal
performance for a particular given pharmaceutical formulation.
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SUMMARY
We affirm the rejection of claim 51 under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Pathak, Benneker, and Chu. Claims
52-59 fall with claim 51.

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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