Ex Parte Bergeron

Board of Patent Appeals and Interferences

May 28, 2004

10091591 (B.P.A.I. May. 28, 2004)

Paper No. 19

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte Raymond J. Bergeron
__________

Appeal No. 2004-1008
Application No. 10/091,591
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ON BRIEF[1]
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Before ADAMS, MILLS, and GRIMES, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on the appeal under 35 U.S.C. § 134 from the examiner’s final rejection of claims
1-7, which are all the claims pending in the application.
Claim 1 is illustrative of the subject matter on appeal and is reproduced below:
1. An anti-diarrheal or gastrointestinal anti-spasmodic pharmaceutical composition
comprising [A] an effective amount of a compound having the formula:
R1-N
1(R2)-(CH2)x-N
2H-Q-N3H-(CH2)y-N
4(R3)-R4 (I)

wherein: R1, R2, R3, R4 are the same or different and are H, alkyl, cycloalkyl or aralkyl having
from 1 to 12 carbon atoms, or a heterocyclic group having from 3 to 10 atoms wherein the
hetero atom is said N1 or N4;
Q is a cycloalkyl group having from 3 to 10 carbon atoms;
x is an integer from 3 to 6, inclusive;
and y is an integer from 3 to 6, inclusive;
or (II) a salt thereof with a pharmaceutically acceptable acid; and [B] a pharmaceutically
acceptable carrier therefor.
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The examiner relies on the following reference:
Bergeron, Jr. (Bergeron) 5,962,533 Oct. 5, 1999
GROUND OF REJECTION
Claims 1-7 stand rejected under 35 U.S.C. § 102(b) as anticipated by Bergeron.
We affirm.
DISCUSSION
Given its brevity we reproduce the examiner’s statement of the rejection in full:
Claims 1-7 are rejected under 35 U.S.C. 102(b) as being anticipated by 5,962,533
[Bergeron]. ‘533 discloses compositions (column 3, lines 59-60) comprising the instant
compound (column 4, Table 1, compounds 33 and 34) and that they are used to treat
diarrhea. Table 1, compounds 33-34 disclose a compound in which Q is a cyclohexyl
group connected as the trans isomer, R1 [sic] and R4 [sic] are CH2CH3 [sic], R2 [sic]
and R3 [sic] are H and x and y are 4. This corresponds to the compound of the
composition of claims 1, 2, 3 and 7 in which R1 [sic] and R4 [sic] are alkyl, R2 [sic] and
R3 [sic] are H, Q is a cyclohexyl group connected as the trans isomer and x and y are 4.
It is noted that appellant has not argued the specific limitations of dependent claim 4-6.
Furthermore, he recites on page 3 of the Brief that “The appealed claims stand or fall
together.”
As we understand the examiner’s statement, appellant’s claims are anticipated by compounds 33
and 34 as set forth in Table 1 of Bergeron. The examiner is correct in that Bergeron discloses
(column 3, lines 59-62), an “object of the invention [is] to provide novel pharmaceutical compositions
methods of treating human and non-human animals with the novel polyamine derivatives.” However,
contrary to the examiner’s assertion, according to Bergeron (column 3, line 65 through column 4, line
37, emphasis added):
The above and other objects are realized by the present invention, one embodiment of
which comprises polyamines having the formula:
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… wherein at least one of the
bridging groups A, B and C
contains at least one
–CH(OH)- group which is not
alpha- to either of the
nitrogen atoms.

As appellant points out (Brief, page 5, emphasis original), “the only polyamines disclosed by the
patent (other than those disclosed in col. 17, lines 27-59 [2]) to be effective anti-diarrheals are those
… which contain at least one CH(OH) group in at least one of the bridging groups.” In contrast, in
appellant’s claimed invention none of the bridging groups contain CH(OH) groups. Brief, page 5. In
response, the examiner finds (Answer, page 4), since “claim 1 recites
a ‘…composition comprising… an efrective [sic] amount of a compound…’ [t]he instant comprising
language is open-ended and does not exclude the CH(OH) group of … [Bergeron].” In this regard,
we agree with appellant (Reply Brief, page 2),
the so-called “comprising language” does not modify the definition of the active
anti-diarrheal, i.e., the polyamine. The language of the claim defining the polyamine is
the structural formula (I) of claim 1 which, when read in conjunction with the “wherein”
clause appearing immediately thereafter, … excludes the CH(OH) group containing
polyamines disclosed by … [Bergeron] to be useful for the treatment of diarrhea.

Stated differently, the word “comprising” modifies the composition not the compound of formula I.
Thus the composition may comprise the compound of formula I and other ingredients, but the
compound itself has must be consistent with the requirements of formula I.
Nevertheless, appellant does not dispute that compounds 33 and 34, as set forth in Table 1
of Bergeron, “are embraced by the structural formulae of the rejected claims.” Brief, page 5.
Appellant, however, asserts (Brief, bridging paragraph, pages 5-6, emphasis removed), “there is no
disclosure in the reference that compounds 33 and 34 are anti-diarrheals. There is no disclosure in
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the reference of a pharmaceutical composition suitable for the treatment of diarrhea that contains
either compound 33 or 34.” According to appellant (Brief, page 6),
Table 1 of the patent sets forth the calculated and actual K i values for a wide variety of
polyamines. The table was compiled by patentee as a first step in trying to predict
which polyamines would be effective anti-diarrheals. See col. 6, lines 25-60. Table 1 …
includes 34 compounds and, as stated above, merely delineates the K i values for the
listed polyamines.
In this regard, we note that the examiner fails to identify any portion of Bergeron that describes a
composition-comprising compound 33 or 34. We do, however, recognize the examiner’s argument
(Answer, page 4), “the fact that compounds 33 and 34 are not disclosed as having anti-diarrheal
properties does not remove them as references. It is well-established that intended use does not
impart patentability in a composition claim.” See In re Zierden 411 F.2d 1325, 1329, 162 USPQ 102,
104 (CCPA 1969):
A mere statement of a new use for an otherwise old or obvious composition cannot
render a claim to the composition patentable. As we said in In re Lemin, 51 CCPA 942,
326 F.2d 437, 140 USPQ 273, 276 (1964),
Appellants are clearly correct in demanding that the subject matter as a whole
must be considered under 35 U.S.C. 103. But in applying the statutory test, the
differences over the prior art must be more substantial than a statement of the
intended use of an old composition. … It seems to us that the composition …
would be exactly the same whether the user were told to cure pneumonia in
animals with it … or to promote plant growth with it (as here). The directions on
the label will not change the composition….

See also, In re Spada, 911 F.2d 705, 708, 15 USPQ2d 1655, 1657 (Fed. Cir. 1990) (“[t]he discovery
of a new property or use of a previously known composition, even when that property and use are
unobvious from the prior art, cannot impart patentability to claims to the known composition”).
Accordingly, claim 1[3] simply requires a composition-comprising compound of formula I and a
pharmaceutically acceptable carrier.
As set forth in Bergeron (column 19, lines 35-32), “[a]ll of the compounds [of Table 1] were
screened for their 48 and 96 hour IC50 values in L1210 cell culture assays.” At column 20, lines
45-50, Bergeron discloses that to determine IC50 values, the polyamine derivatives of Table 1 were
diluted in sterile water and filtered through a 0.2 ?m filter. In our opinion sterile water is a
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pharmaceutically acceptable carrier. Thus, Bergeron discloses a composition comprising a
compound of formula 1 (see Table 1, compounds 33 and 34) in a pharmaceutically acceptable carrier
(sterile water).
The question remains, however, as to whether Bergeron teaches a composition comprising an
amount of compound 33 or 34 that would meet the requirements of appellant’s claimed invention?
While appellant’s specification does not explicitly define the phrase “an effective amount”, appellant
discloses (page 11, lines 12-15), “[p]harmaceutical compositions according to the invention can, for
example, … contain from approximately 0.05 g to approximately 10.0 g, and preferably from
approximately 0.3 g to approximately 1.0 g, of active ingredient.”[4] While Bergeron does not teach
the amount of the compound in the composition, it appears, absent evidence to the contrary that the
composition of claim 1 is identical or substantially identical to the composition disclosed by
Bergeron as useful in the determination of IC50 values. Appellant’s burden under
the circumstances presented herein was described in In re Best, 562 F.2d 1252,
1255, 195 USPQ 430, 433-434 (CCPA 1977) as follows:
Where, as here, the claimed and prior art products are identical or substantially
identical, or are produced by identical or substantially identical processes, the PTO can
require an applicant to prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product.… Whether the rejection is based on
`inherency' under 35 U.S.C. ' 102, on `prima facie obviousness' under 35 U.S.C. ' 103,
jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by
the PTO's inability to manufacture products or to obtain and compare prior art products
[footnote omitted].

We find no evidence on this record that the composition of Bergeron does not necessarily or
inherently possess the characteristics of appellant’s claimed composition. Accordingly, we affirm the
rejection of claim 1 under 35 U.S.C.
§ 102(b) as anticipated by Bergeron. Claims 2-7 fall together with claim 1. However, since our basis
for affirming the rejection differs from the examiner’s, we designate the affirmance as a new ground
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of rejection under 37 CFR
§ 1.196(b) in order to provide appellant with a fair opportunity to respond. See In re Kronig, 539 F.2d
1300, 1302-03, 190 USPQ 425, 426-27 (CCPA 1976).
TIME PERIOD FOR RESPONSE
This opinion contains a new ground of rejection pursuant to 37 CFR § 1.196(b). 37 CFR § 1.196(b)
provides that, “[a] new ground of rejection shall not be considered final for purposes of judicial
review.”
37 CFR § 1.196(b) also provides that the appellant, WITHIN TWO MONTHS FROM THE DATE OF
THE DECISION, must exercise one of the
following two options with respect to the new ground of rejection to avoid termination of proceedings
(§ 1.197(c)) as to the rejected claims:
(1) Submit an appropriate amendment of the claims so rejected or a showing of
facts relating to the claims so rejected, or both, and have the matter reconsidered by
the examiner, in which event the application will be remanded to the examiner….

(2) Request that the application be reheard under § 1.197(b) by the Board of Patent
Appeals and Interferences upon the same record….

No time period for taking any subsequent action in connection with this appeal may be extended
under 37 CFR § 1.136(a).

AFFIRMED; 37 CFR § 1.196(b)

)
Donald E. Adams )
Administrative Patent Judge )
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)
) BOARD OF PATENT
)
Demetra J. Mills ) APPEALS AND
Administrative Patent Judge )
) INTERFERENCES
)
)
Eric Grimes )
Administrative Patent Judge )

MILES & STOCKBRIDGE PC
1751 PINNACLE DRIVE
SUITE 500
MCLEAN VA 22102-3833
[1] Appellant waived his request for oral hearing. Paper No. 18, received April 29, 2004. Accordingly, we considered this
appeal on Brief.
[2] The examiner presents no evidence on this record that the other anti-diarrheals DEHSPM, (HO)2DEHSPM, DENSPM,
DPNSPM and HSPM as set forth in col. 17, lines 27-59 of Bergeron, fall within the scope of the formula set forth in
appellant’s claims. In this regard, we note that Table 1 of Bergeron, sets forth the structure of DENSPM, No. 11 and
DEHSPM, No. 20 of Bergeron. In addition, Table 3 of Bergeron sets forth the structure of DEHSPM, and (HO)2DEHSPM.
[3] According to appellant (Brief, page 3), “[t]he appealed claims stand or fall together.” Accordingly, we limit our
discussion to representative independent claim 1. Claims 2-7 stand or fall together with claim 1. 37 CFR § 1.192(c)(7)
(2002).
[4] See also, Specification, page 10, “a suitable dose of agent will lie in the range of about .0001 mg to about 500 mg per
kilogram of mammal body weight being treated.”
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