Ex Parte Pieper et al

Board of Patent Appeals and Interferences

Aug 9, 2011

11182382 (B.P.A.I. Aug. 9, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL P. PIEPER and MICHEL PAIRET
__________

Appeal 2010-010440
Application 11/182,382
Technology Center 1600
__________

Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness and obviousness-type double patenting. We have
jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
The following claim is representative and reads as follows:
1. A pharmaceutical formulation comprising:
(a) at least one anticholinergic of formula 1

wherein X- is an anion with a single negative charge;
(b) at least one corticosteroid (2); and
(c) formoterol (3),
or the enantiomers, mixtures of the enantiomers, racemates, or
physiologically acceptable acid addition salts thereof.

Cited References

The Examiner relies on the following prior art references:
Germeyer et al.[‟539] US 2003/0199539 A1 Oct. 23, 2003
Germeyer et al. [„856] US 6,790,856 A2 Sep. 14, 2004
Germeyer et al. [„600] U.S. 7,429,600 Sep. 8, 2008
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The following are Related Appeals:

Copending Application No. 10/891,554
Copending Application No. 10/891,787
Copending Application No. 10/006,940
Copending Application No. 11/420,872
Copending Application No. 10/891,562

Grounds of Rejection
1. Claims 1-5, 7-17 and 22-23 are rejected under 35 U.S.C. § 103(a) for
obviousness over Germeyer „539.
2. Claims 1-5, 7-13, 17 and 22-23 are rejected for obviousness-type-double
patenting over claims 23, 25 and 27 of Germeyer „856.
3. Claims 1-5, 7-13, 17 and 22-23 are rejected for obviousness-type-double
patenting over claims 1-20 of U.S. Patent No.7,429,600 in view of Germeyer
„856.
4. Claims 1-5, 7, 11-13 and 17 are provisionally rejected for obviousness-
type double patenting over claims 1, 3, 5,-8 and 30 of copending Application
No. 10/891,554 in view of Germeyer „856.
5. Claims 1-4, 7-15, 17 and 21-22 are provisionally rejected for
obviousness-type double patenting over claims 1-11, 14-21, 30-36, and 39-
41 of copending Application No. 10/891,787 in view of Germeyer „856.
6. Claims 1-5, 7-13, and 22-23 are provisionally rejected for obviousness-
type double patenting over claims 1, 3,-11, 90 and 93 of copending
Application No. 11/006,940 in view of Germeyer „856.

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7. Claims 1-5, 7-13, and 22-23 are provisionally rejected on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
(1) claims 1and 6 of copending Application No. 11/420,872 (copending
'872) in view of Germeyer „856 and (2) claims 1-3, 11-12, 28, 32, and 34 of
copending Application No. 10/891,562 (copending '562) in view of
Germeyer „856.

FINDINGS OF FACT
The findings of fact are set forth in the Answer at pages 5-19.

Discussion
ISSUE
An exemplary rejection of the Examiner and his conclusions follow.

Germeyer-2003 discloses fluorenecarboxylic acid esters of general
formula 1, which encompass the structure of compound of formula 1
in claim 1 of the instant application, including the substantially
overlapping Markush groups identifying the X
-
anion (abstract;
[0002]-[0025]; claims 1-12). Germeyer-2003 discloses Appellants'
anticholinergic of formula 1 in Example 6 ([0089]-[0094]) and
indicates that it is a particularly important compound [0033]…
Germeyer-2003 discloses that compounds of formula 1 may be used
alone or in combination with other pharmacologically active
compounds, including corticosteroids [0111], such as flunisolide,
beclomethasone, triamcinolone, budesonide, fluticasone, mometasone,
ciclesonide, rofleponide, GW 215864, KSR 592, ST-126, and
dexamethasone, including sodium salts, sulfobenzoates, phosphates,
isonicotinates, acetates, propionates, dihydrogen phosphates,
palmitates, pivalates, or furoates, and hydrates of said steroids [0113]
and betamimetics, wherein suitable betamimetics are disclosed in
[0112]. Suitable forms of said compositions include solutions, which
may be administered by inhalation ([0121], [0129], and [0136]-
[0141]).
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(Ans. 5-6.)

Germeyer „539 does not teach a specific formulation comprising at
least one anticholinergic of formula 1, at least one corticosteroid and at least
one betamimetic. (See Ans. 7.) However, the Examiner finds that Germeyer
„539 suggests such a combination. (See Id.)
Appellants argue “[t]here is no fair direction to one of ordinary skill in
the art… to make the multiple specific selections necessary from
Germeyer‟s general teachings to arrive at the claimed invention.” (App. Br.
4.)
Appellants argue that the Declaration under 37 CFR § 1.132 of Dr.
Thierry Bouyssou provides evidence of synergism and is evidence of
nonobviousness. (See App. Br. 6-7.)
The issues are: Does the cited prior art suggest the pharmaceutical
formulation, as claimed? Do the claims of the „600 patent and copending
applications in combination with the claims of the „856 patent suggest the
pharmaceutical formulations, as claimed?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
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of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “In determining
whether obviousness is established by combining the teachings of the prior
art, „the test is what the combined teachings of the references would have
suggested to those of ordinary skill in the art.‟” In re GPAC Inc., 57 F.3d
1573, 1581 (Fed. Cir. 1995).
“[I]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., 874 F.2d 804, 807 (Fed. Cir. 1989)
(quoting In re Lamberti, 545 F.2d 747, 750, 192 USPQ 278, 280 (CCPA
1976).)
In Merck, a prior art patent disclosed genus of 1200 effective
combinations of compounds, including the claimed combination. The court
found that the “[d]isclos[ure of] a multitude of effective combinations does
not render any particular formulation less obvious.” Merck & Co. Inc. v.
Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
The burden of demonstrating unexpected results rests on the party
asserting them, and “it is not enough to show that results are obtained which
differ from those obtained in the prior art: that difference must be shown to
be an unexpected difference.” In re Klosak, 455 F.2d 1077, 1080 (CCPA
1972). “[U]nexpected results must be established by factual evidence. Mere
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argument or conclusory statements in the specification does not suffice.” In
re DeBlauwe, 736 F.2d 699, 705 (Fed. Cir. 1984). “[W]hen unexpected
results are used as evidence of nonobviousness, the results must be shown to
be unexpected compared with the closest prior art.” In re Baxter-Travenol
Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). “The evidence presented to rebut
a prima facie case of obviousness must be commensurate in scope with the
claims to which it pertains.” In re Dill, 604 F.2d 1356, 1361 (CCPA
1979)(emphasis added). Expected beneficial results are not evidence of
nonobviousness. See In re Skoner, 517 F.2d 947, 950 (CCPA 1975).
Obviousness-type double patenting entails a two-step analysis. First,
the allegedly conflicting claims are construed and, second, the difference(s)
between the claims are considered to determine whether the claims are
patentably distinct. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955,
968 (Fed. Cir. 2001). “A later patent claim is not patentably distinct from an
earlier patent claim if the later claim is obvious over, or anticipated by, the
earlier claim.” Id.

ANALYSIS
We agree with the Examiner‟s fact finding, statement of the rejections
and responses to Appellants‟ arguments as set forth in the Answer and adopt
them as our own. Thus we agree in each of the above rejections 1-7 that the
Examiner has set forth a prima facie case of obviousness and obviousness-
type double patenting. Each of the rejections set forth by the Examiner
present similar issues, and therefore we discuss them together. We provide
the following additional comments.
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Appellants argue “[t]here is no fair direction to one of ordinary skill in
the art… to make the multiple specific selections necessary from
Germeyer‟s general teachings to arrive at the claimed invention.” (App. Br.
4.)
We are not persuaded. Germeyer „539 and the claims of the other
cited patents and copending applications teach a compound according to
formula I and that this compound may be generally combined with any
betamimetic, including formoterol, and that it may also generally be
combined with one of many corticosteroids. (See Ans. 8.) In Merck, the
court found that the “[d]isclos[ure of] a multitude of effective combinations
does not render any particular formulation less obvious.” Merck & Co. Inc.
v. Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
Appellants have provided no evidence that one of ordinary skill in the art
would not have expected all betamimetics generally disclosed in Germeyer
„539 or all corticosteroids disclosed therein to have provided similar results
when in combination with the claimed compound. Similarly, Appellants
have not shown that all betamimetics generally claimed in Germeyer „856
or all corticosteroids claimed therein would not have provided similar results
when in combination with the claimed compound of the „600 patent and the
copending applications.
Appellants argue that the Declaration under 37 CFR § 1.132 of Dr.
Thierry Bouyssou provides evidence of synergism and is evidence of
nonobviousness. (See App. Br. 6-7.)
We find that the Declaration of Bouyssou is not sufficient to rebut the
Examiner‟s prima facie case of obviousness. “The evidence presented to
rebut a prima facie case of obviousness must be commensurate in scope with
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the claims to which it pertains.” In re Dill, 604 F.2d at 1361. The pending
claims require a compound of formula I in combination with formoterol and
a corticosteroid. Appellants‟ Declaration evidence only provides a
comparison between either formoterol or the scopine ester methobromide
compounds alone or their combination, but not with the additional inclusion
of the corticosteroid as required by the claims and suggested by the cited
and/or claimed prior art. Thus the comparative evidence presented is not
commensurate in scope with the pending claims, nor has a comparison been
made to the closest prior art.
Furthermore, Appellants have provided no evidence in the Declaration
that one of ordinary skill in the art would not have expected all betamimetics
generally disclosed in Germeyer „539, and the claims of the other copending
applications or Germeyer „856, or all corticosteroids disclosed therein, to
have provided similar results when in combination with the claimed
compound of formula I. Thus one of ordinary skill in the art would have
expected at least additive beneficial results from the combination of a
compound according to formula I disclosed in Germeyer „539, Germeyer
„856, Germeyer „600 or the claims of the other copending applications with
any betamimetic or corticosteriod. Such expected beneficial results are not
evidence of nonobviousness. See In re Skoner, 517 F.2d 947, 950 (CCPA
1975). Rejections 1-7 are affirmed.

CONCLUSION OF LAW
The cited references support the Examiner‟s obviousness rejection and
obviousness-type double patenting rejections which have not been rebutted
by Appellants‟ evidence of non-obviousness.
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TIME PERIOD
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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