Ex Parte Schulze et al

Board of Patent Appeals and Interferences

Apr 5, 2010

10451482 (B.P.A.I. Apr. 5, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BERND SCHULZE and EBERHARD NIESCHLAG
__________

Appeal 2009-013421
Application 10/451,482
Technology Center 1600
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Decided: April 5, 2010
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Before LORA M. GREEN, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to steroid
gel compositions. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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Statement of the Case
Background
“A shortage of testosterone (hypogonadism) may be classified into
two principle forms, which are designated primary and secondary
hypogonadism” (Spec. 1, ll. 11-12). According to the Specification, the
“treatment usually is a substitution therapy which effectively can be
measured directly based on the testosterone concentration in serum. The aim
of the testosterones substitution is to increase the testosterone concentration
in serum to the normal value” (Spec. 1, ll. 22-25).
The Claims
Claims 1-7, 9, 12-14, 17-20, and 22-27 are on appeal. Claim 1is
representative and reads as follows:
1. A gel composition on alcoholic basis,
consisting of 0.01 to 10.0 weight % of at least one steroid,
0.01 to 20.0 weight % of at least one C3-C4 diol, 30 to 90
weight % of at least one alcohol, 0.01 to 1 weight % of at
least one pH-stabilizer, 0.1 to 6 weight % of at least one
poly(meth)acrylic acid-based polymer, optional excipients
selected from the group consisting of preservatives, anti-
oxidants, stabilizers, solution enhancers, vitamins, coloring
agents, and odor-improving agents, and water.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Ferrari US 3,860,712 Jan. 14, 1975
Kigasawa et al. US 4,952,560 Aug. 28, 1990
Dudley et al. US 6,503,894 B1 Jan. 7, 2003
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The issues
A. The Examiner rejected claims 1-4, 6, and 17 under 35 U.S.C. § 102(b)
as anticipated by Kigasawa (Ans. 3).
B. The Examiner rejected claims 1-7, 9, 12-14, 17-20, and 22-27 under
35 U.S.C. § 103(a) as obvious over Kigasawa, Ferrari, and Dudley (Ans. 4-
6).
A. 35 U.S.C. § 102(b) over Kigasawa
The Examiner finds that Kigasawa teaches “a topical gel comprising
at least 0.01-15% of a drug such as testosterone, estradiol and thyroid
hormones (col. 7, lin. 45-48; col. 8, lin. 19-26)” (Ans. 3). The Examiner
finds that Kigasawa teaches that the “gel formulation further comprises 2-
5% propylene glycol (col. 4, lin. 40-43, lin. 55-59; Table 1-3); 5-35%
ethanol or isopropanol (col. 2, lin. 50-56; Table 1-3), 1-4% of pH stabilizing
compositions (col. 6, lin. 35-39), 0.5-5% poly(meth)acrylic acid polymers
(col. 5, lin. 35-40, lin. 48-53), along with water, and other stabilizing agents”
(Ans. 3).
Appellants focus on the closed nature of the claims to distinguish
Kigasawa, who requires water-soluble proteins. Appellants argue that the
“claim transitional phrase ‘consisting of’ causes the claims to exclude
significant additional components, such as the water-soluble protein to
promote percutaneous adsorption of a drug as disclosed in [Kigasawa]”
(App. Br. 4).
In view of these conflicting positions, we frame the anticipation issue
before us as follows:
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Does the evidence of record support the Examiner’s conclusion that
Kigasawa teaches a composition which satisfies the requirements of claim
1?
Findings of Fact (FF)
1. The Specification teaches that the “composition may further
comprise usual carriers, excipients and optional further active ingredients.
Preferred excipients are selected from the group of preservatives,
antioxidants, stabilizers, solution enhancing agents, vitamins, colouring
agents and odour-improving agents” (Spec. 10).
2. Kigasawa teaches an “ointment is a semisolid pharmaceutical
preparation, in the form of a gel or cream, for local administration of a drug”
(Kigasawa, col. 1, ll. 10-12).
3. Kigasawa teaches that “this invention relates to an ointment
base characterized by containing (1) a water-soluble protein having the
property to promote percutaneous absorption of drugs, (2) monohydric
alcohol” (Kigasawa, col. 1, ll. 55-58).
4. Kigasawa teaches drugs including testosterone (Kigasawa, col.
7, l. 45) and teaches that the “concentration of the drug need only be that
which exhibits the expected clinical effect, and in many instances ranges
from 0.01 to 15 weight percent” (Kigasawa, col. 8, ll. 19-21).
5. Kigasawa teaches the use of a wetting agent such as propylene
glycol (Kigasawa, col. 4, l. 47) from “about 2 to 30 weight percent”
(Kigasawa, col. 4, l. 59).
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6. Kigasawa teaches alcohols “such as ethanol, isopropanol and
butanol . . . preferably 5 to 35 weight percent based on the ointment base”
(Kigasawa, col. 2, ll. 50-56).
7. Kigasawa teaches polymers including polymethacrylic acid
(Kigasawa, col. 5, l. 40) which are “preferably from about 0.5 to 5 weight
percent” (Kigasawa, col. 5, l. 52).
8. Kigasawa teaches that the “amount of such pH adjusting agent
is generally about 0.1 to 5 weight percent” (Kigasawa, col. 6, ll. 36-37).
Principles of Law
“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. v. Union Oil Co. of California, 814 F.2d
628, 631 (Fed. Cir. 1987).
Analysis
There is no dispute that Kigasawa teaches, at separate locations
throughout the reference, each of the elements of the claims (FF 2-8).
However, Kigasawa does not teach a single composition with each of the
claimed elements, but requires selection of the elements from groups of
disclosed compounds (see, e.g., Kigasawa, col. 6-7, listing possible drugs).
As stated in Arkley, an anticipatory reference under 35 U.S.C. § 102:
. . . must clearly and unequivocally disclose the claimed
compound or direct those skilled in the art to the compound
without any need for picking, choosing, and combining
various disclosures not directly related to each other by the
teachings of the cited reference. Such picking and choosing
may be entirely proper in the making of a 103, obviousness
rejection, where the applicant must be afforded an
opportunity to rebut with objective evidence any inference
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of obviousness which may arise from the similarity of the
subject matter which he claims to the prior art, but it has no
place in the making of a 102, anticipation rejection.

In re Arkley, 455 F.2d 586, 587-588 (CCPA 1972).
The instant situation is similar to Arkley, where the instant rejection is
not a § 103 rejection, but rather a § 102, anticipation rejection which would
require picking and choosing from parts of the Specification in order to
arrive at the claimed invention. In order to reach the claim, the ordinary
practitioner would have had to select a particular drug, steroid, a particular
polymer, polymethacrylic acid, a particular wetting agent, and so on. This
picking and choosing is not consistent with an anticipation rejection.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Kigasawa teaches a composition which satisfies the requirements of
claim 1.
B. 35 U.S.C. § 103(a) over Kigasawa
The Examiner finds that “[a]s discussed above [Kigasawa] discloses
an alcoholic base topical formulation comprising steroids. The referent
discloses pH stabilizers used in the formulation, however is silent to the
specific agent of the instant claims. The substitution of a known compound
into a formulation is an obvious step to one of ordinary skill in the art and
can be seen in [Ferrari]” (Ans. 4). The Examiner concludes that it “would
have been obvious to one of ordinary skill in the art to deliver the combine
the disclosures of the prior art in order to provide a stable transcrotal deliver
composition useful in treating hypogonadism” (Ans. 5).
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Appellants argue that “all of the compositions disclosed in the ‘560
patent [Kigasawa] contain a water-soluble protein, which is excluded from
the pending claims. Neither the ‘712 patent [Ferrari] nor the ‘894 patent
[Dudley] compensates for the deficiencies of the ‘560 patent [Kigasawa]”
(App. Br. 6). Appellants argue that “the ‘560 patent [Kigasawa] clearly
indicates that the water-soluble protein is an essential component of the
composition” (Reply Br. 2).
In view of these conflicting positions, we frame the obviousness issue
before us as follows:
Does the evidence of record support the Examiner’s conclusion that
the cited references render obvious the composition of claim 1?
Findings of Fact
9. The Examiner finds that the “water-soluble protein such as
gelatin would act as a coloring agent” (Ans. 3).
Principles of Law
“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). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. Moreover, an “[e]xpress suggestion to substitute
one equivalent for another need not be present to render such substitution
obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). As noted by the
Court in KSR, “[a] person of ordinary skill is also a person of ordinary
creativity, not an automaton.” 550 U.S. at 421.
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“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 [A]pplicant to prove that the prior art
products do not necessarily or inherently possess the characteristics of his
claimed product.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977). “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.” Id. at
1255.
Analysis
As noted above, Kigasawa teaches each of the elements required by
Claim 1 (FF 2-8). The instant rejection is for obviousness and Arkley notes
that “picking and choosing may be entirely proper in the making of a 103,
obviousness rejection.” Arkley, 455 F.2d at 587.
The Examiner finds that gelatin, a protein required by Kigasawa,
functions as a coloring agent (FF 9). Appellants do not dispute that gelatin
may function as a coloring agent, instead arguing that “gelatin is not
routinely used in the art as a coloring agent” (Reply Br. 2).
Appellants are relying on the closed, “consisting of”, transition phrase
in Claim 1 to exclude the composition of Kigasawa because Kigasawa
requires the presence of gelatin and claim 1 does not expressly require
gelatin. Claim 1 does permit, however, the optional presence of excipients,
including coloring agents (see Claim 1). The Examiner has made the
reasonable, and undisputed, finding that the gelatin required by Kigasawa is
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an excipient coloring agent, and therefore is an optional element permitted
by the express language of the otherwise closed Claim 1 (see Claim 1).
Appellants argue that “all of the compositions disclosed in the ‘560
patent [Kigasawa] contain a water-soluble protein, which is excluded from
the pending claims” (App. Br. 6). Appellants also argue that “the ‘560
patent [Kigasawa] clearly indicates that the water-soluble protein is an
essential component of the composition” (Reply Br. 2).
We are not persuaded. The essential gelatin of Kigasawa is not
excluded from the composition of Claim 1 because the Claim 1 is permissive
of coloring agents and it is undisputed that gelatin is a coloring agent (FF 9;
Reply Br. 2). That Kigasawa requires the gelatin, rather than optionally
permits gelatin, does not alter that fact that Claim 1 permits the presence of
gelatin as a coloring agent. Therefore, Claim 1 as written is obvious over
the disclosure of Kigasawa, Ferrari, and Dudley.
Conclusion of Law
The evidence of record support the Examiner’s conclusion that the
cited references render obvious the composition of claim 1.
SUMMARY
In summary, we reverse the rejection of claims 1-4, 6, and 17 under
35 U.S.C. § 102(b) over Kigasawa.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) over
Kigasawa, Ferrari, and Dudley. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2-7, 9, 12-14,
17-20, and 22-27 as these claims were not argued separately.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).
AFFIRMED

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