Ex Parte Steiner et al

Board of Patent Appeals and Interferences

Sep 25, 2003

09879888 (B.P.A.I. Sep. 25, 2003)

The opinion in support of the decision being entered
today was not written for publication and
is not binding precedent of the Board

Paper No. 16

UNITED STATES PATENT AND TRADEMARK OFFICE

__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOSEPH P. STEINER
and GREGORY S. HAMILTON
___________

Appeal No. 2003-1169
Application No. 09/879,888
___________

ON BRIEF
___________

Before WILLIAM F. SMITH, SCHEINER and PAWLIKOWSKI, Administrative
Patent Judges.

PAWLIKOWSKI, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 17-33.
This application is related to Application Serial Number
09/784,174 (Appeal No. 2003-1102) and Application Serial Number
09/781,427 (Appeal No. 2003-0924).
Claims 17 and 33 are representative of the subject matter on
appeal, and are set forth below:
17. A pharmaceutical composition which comprises:
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Application 09/879,888

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(i) an effective amount of nitrogen-containing heterocyclic
compound having two or more heteroatoms, wherein said compound
has a substituent —C(W)-C(Y)- which is attached to a nitrogen
atom of the heterocyclic ring,

wherein W and Y are independently selected from the group
consisting of O, S, CH2 and H2, and wherein said compound is
additionally substituted with a ester or amide substituent
attached to any atom of the heterocyclic ring other than said
nitrogen atom,

provided that said ester or amide substituent is not an N-
oxide of an ester or amide and further provided that said amide
substituent is linked to the heterocyclic ring with a carbon-
carbon bond;

(ii) a second compound for treating alopecia or promoting
hair growth; and

(iii) a pharmaceutically acceptable carrier.

33. A pharmaceutical composition which comprises:

(i) an effective amount of a nitrogen-containing
heterocyclic compound having two or more heteroatoms;

wherein said compound has a substituent –C(W)-C(Y)- which is
attached to a nitrogen atom of the heterocyclic ring, wherein W
and Y are independently selected from the group consisting of O,
S, CH2, and H2, and

wherein said compound is additionally substituted with an
ester or amide substituent attached to any atom of the
heterocyclic ring other than said nitrogen atom,

provided that said ester or amide substituent is not an N-
oxide of an ester or amide and further provided that said amide
substituent is linked to the heterocyclic ring with a carbon-
carbon bond; and

(ii) a pharmaceutically acceptable carrier.

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The examiner relies upon the following references as
evidence of unpatentability:
Li et al. (Li ‘187) 5,801,187 Sep. 1, 1998
Li et al. (Li ‘972) 6,200,972B1 Mar. 13, 2001
Li et al. (Li ‘544) 6,218,544B1 Apr. 17, 2001
Claims 5, 6, and 8 of related Application Serial Number
09/784,174 (Appeal No. 2003-1102)

Claim 33 stands rejected under 35 U.S.C. § 102(b) as being
anticipated by Li ‘187, Li ‘972, or Li ‘544.
Claims 17 through 32 stand provisionally rejected under the
judicially created doctrine of obviousness-type double patenting
as being unpatentable over claims 5, 6, and 8 of related
Application Serial Number 09/784,174 (Appeal No. 2003-1102).

OPINION
We have carefully reviewed appellants’ Brief and the
examiner’s Answer. This review has led us to conclude that the
35 U.S.C. § 102(b) rejection is well-founded. However, we cannot
reach the merits of the obviousness-type double patenting
rejection at this time and therefore remand this application to
the examiner in connection with this rejection.

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I.
With regard to the 35 U.S.C. § 102(b) rejection, the
examiner states that the compound recited in appellants’ claim 33
and the compound of Formula I in each of the Li references are
the same for the reasons explained on pages 3 and 4 of the
Answer.
In response, appellants state “[h]ow can a disclosure of a
compound, like that of the ‘l87 patent’s Formula I, anticipate a
composition, like that of present claim 33?” Appellants repeat a
similar position for each of the Li references. Brief, pages 3-
4.
In response, on page 6 of the Answer, the examiner states
that she did explain that each of the Li references anticipates
the composition set forth in claim 33 for the reasons provided on
pages 3-4 of the answer. We agree with the examiner’s position
and understanding of each of the Li references. Appellants do
not point to any differences between the compound recited in
claim 33 and the compound set forth in Formula I of each of the
Li references.
We therefore affirm the 35 U.S.C. § 102(b) rejection of
claim 33.

II.
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With regard to the provisional rejection under the doctrine
of obviousness-type double patenting, the examiner states that
the instant claims read on claims 5, 6, and 8 of Application
Serial No. 09/784,174 (Appeal No. 2003-1102) “when J and K in
‘174 form a heterocyclic ring”. Answer, pages 4-6.
In response, appellants argue that “[o]verlap itself,
however, cannot establish a prima facie case of nonstatutory
double patenting.” Brief, page 5.
We note that the determination of obviousness-type double
patenting essentially involves the determination of obviousness
under 35 U.S.C. § 103, except that the first patent disclosure is
not applicable as “prior art.” See, e.g., Chisum, § 9.03[3]. In
In re Longi, the Federal Circuit discussed the similarity between
rejections under § 103 and “obviousness-type” double patenting:
We note that the Board did not make the instant
rejection under § 103. However, a double patenting of
the obviousness type rejection is “analogous to [a
failure to meet] the non-obviousness requirement of 35
U.S.C. § 103” except that the patent principally
underlying the double patenting rejection is not
considered prior art. In re Braithwaite, 379 F.2d 594,
600, n.4, 54 C.C.P.A. 1589, 1597, n.4, 154 USPQ 29, 34
(1967). Therefore, our analysis concerning the
correctness of the Board’s decision in the instant case
parallels our previous guidelines for a § 103
rejection. See, e.g., In re De Blauwe, 736 F.2d 699,
222 USPQ 191 (Fed. Cir. 1984).

In re Longi, 759 F.2d at 892 n.4, 225 USPQ at 648 n.4.
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Because the analysis regarding obviousness-type double
patenting essentially involves the determination of obviousness
under 35 U.S.C. § 103, we note that obviousness under Section 103
is a legal conclusion based upon facts revealing the scope and
content of the prior art, the differences between the prior art
and the claims at issue, the level of ordinary skill in the art,
and objective evidence of nonobviousness. Graham v. John Deere
Co., 86 S.Ct. 684, 383 U.S. 1, 17-18, 148 USPQ 459, 467 (1966).
Upon return of the application, the examiner is therefore to
reweigh the entire merits of the obviousness-type double
patenting rejection according to the criteria set forth in Graham
v. John Deere Co.
Furthermore, in the case of In re Lee, 277 F.3d 1338, 1445,
61 USPQ2d 1430, 1435 (Fed. Cir. 2002), the Court stressed the
import of articulating and making of record knowledge negating
patentability. The examiner is therefore also to reweigh the
entire merits of the rejection and make of record any facts
supporting her position negating patentability.
In specific response to appellants’ statement that
“[o]verlap itself, however, cannot establish a prima facie case
of nonstatutory double patenting”, the examiner is to reweigh the
entire merits of the obviousness-type double patenting rejection
in light of In re Kaplan, 789 F.2d 1574, 1577-1581, 229 USPQ 678,
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681-683 (Fed. Cir. 1987). In this context, the examiner should
expound on the obviousness-type double patenting rejection
according to the analysis set forth in In re Baird, 16 F.3d 380,
382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) and In re Jones, 958
F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992).

III.
Claim 17 recites “an effective amount”. Upon return of the
application, the examiner is to consider what amount is meant by
this phrase, and for what purpose, and whether this phrase is
indefinite under 35 U.S.C. § 112, second paragraph.

IV.
In conclusion, we affirm the anticipation rejection.
However, with regard to the provisional rejection under the
judicially created doctrine of obviousness-type double patenting,
and with regard to the matter raised in Section III, we remand
the application to the examiner to attend to these matters.
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This application, by virtue of its “special” status,
requires an immediate action, MPEP § 708.01(d). It is important
that the Board be informed promptly of any action affecting the
appeal in this case.

AFFIRMED-IN-PART
REMANDED-IN-PART

William F. Smith )
Administrative Patent Judge )
)
)
)
Toni R. Scheiner ) BOARD OF PATENT
Administrative Patent Judge ) APPEALS AND
) INTERFERENCES
)
)
Beverly A. Pawlikowski )
Administrative Patent Judge )

BAP/cam

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GUILFORD PHARMACEUTICALS COMPANY
FOLEY & LARDNER
3000 K Street, N.W.
Washington, DC 20007-5143