Ex Parte VanRheenen

Board of Patent Appeals and Interferences

Apr 21, 2011

10815351 (B.P.A.I. Apr. 21, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
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.
10/815,351 04/01/2004 Verlan H. VanRheenen BRI10 P300 8270
277 7590 04/21/2011
PRICE HENEVELD COOPER DEWITT & LITTON, LLP
695 KENMOOR, S.E.
P O BOX 2567
GRAND RAPIDS, MI 49501
EXAMINER
BADIO, BARBARA P
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
04/21/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte VERLAN H. VANRHEENEN
__________

Appeal 2010-002531
Application 10/815,351
Technology Center 1600
__________

Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
hydrochloride and hydrobromide salts of a particular steroid. The Patent
Examiner rejected the claims on the ground of obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.
Appeal 2010-002531
Application 10/815,351

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STATEMENT OF THE CASE
Claims 1-4, which are all the pending claims, are on appeal. Claim 1
is representative and reads as follows:
1. 17α-Acetoxy-21-methoxy-11β-(4-,N,N-dimethylaminophenyl)-19-
norpregna-4,9,diene-3,20-dione hydrochloride.

The Examiner rejected claims 1-4 under 35 U.S.C. § 103(a) as
unpatentable over Kim1 and Berge.2

OBVIOUSNESS
The Issue
The Examiner’s position is that Kim taught the claimed steroid, but
not its hydrochloride or hydrobromide salts. (Ans. 3.) The Examiner found
that “the conversion of pharmaceutical agents into a salt form is routine,”
and “[a]s discussed by Berge et al., the chemical, biological, physical and
economic characteristics of medicinal agents can be manipulated and
optimized by conversion to a salt form.” (Id. at 3-4.) The Examiner
concluded “[t]he claimed salts are prima facie obvious based on the
teachings of the prior art and the level of skill of the ordinary artisan in the
pharmaceutical art.” (Id. at 4.)
Appellant “admits that the desirability of salt forms of the 19-
norsteroid compounds disclosed by Kim et al. would have been immediately
recognized by those having ordinary skill in the art.” (App. Br. 4.)
However, Appellant contends that “[a]n invention is not obvious unless it is

1 Hyun K. Kim et al., US 2002/0025951 A1, published Feb. 28, 2002.
2 Stephen M. Berge et al., Pharmaceutical Salts, 66 J. PHARM. SCI. 1-18
(1977).
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Application 10/815,351

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obvious how the invention can be made.” (Id.) Accordingly, Appellant
contends that (1) the law requires that prior art underlying an obviousness
rejection must enable making the claimed compounds, and (2) the weight of
the evidence in this case does not support finding that the prior art enabled
making the claimed compounds. (Id. at 5-6.) Appellant contends that the
Declaration of inventor Verlan H. Van Rheenen “shows that it was not
known, nor obvious, how to make the claimed salts . . . .” (Id. at 6.)
The Examiner responds that methods of making hydrochloride and
hydrobromide salts of steroids were known in the art, citing two patents said
to disclose processes “similar to” Appellant’s disclosed process. (Ans. 4-5.)
The Examiner found the Van Rheenen Declaration unpersuasive because
“the issue is not applicant’s process of making the salts but whether said
salts would have been obvious . . . .” (Id. at 5.)
Appellant replies that (1) the patents the Examiner relied on as
evidence of known salt-forming processes allegedly similar to Appellant’s
process do not support the rejection because the differences between the
processes have not been addressed, and (2) the Van Rheenen Declaration
showed that routine processes did not work. (Reply Br. 3.)
The issue on appeal is whether the rejection established that the prior
art enabled a person of ordinary skill in the art to prepare the claimed
compounds.
Findings of Fact
1. It is undisputed that the prior art suggested the desirability of
hydrochloride and hydrobromide salts of Kim’s 19-norsteroids,
including the ones Appellant claims.
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Application 10/815,351

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2. The rejection did not provide evidence that either Kim or Berge
described methods for preparing hydrochloride or hydrobromide salts
of steroid compounds.
Principles of Law
“[I]f the prior art of record fails to disclose or render obvious a
method for making a claimed compound, at the time the invention was
made, it may not be legally concluded that the compound itself is in the
possession of the public.” In re Hoeksema, 399 F.2d 269, 273 (CCPA
1968).
Where claimed subject matter has been rejected as obvious in view of
a combination of prior art references, a proper analysis under § 103 requires,
inter alia, consideration of two factors: (1) whether the prior art would have
suggested to those of ordinary skill in the art that they should make the
claimed composition or device, or carry out the claimed process; and
(2) whether the prior art would also have revealed that in so making or
carrying out, those of ordinary skill would have a reasonable expectation of
success. Both the suggestion and the reasonable expectation of success must
be founded in the prior art, not in the applicant's disclosure. In re Vaeck,
947 F.2d 488, 493 (Fed. Cir. 1991).
Analysis
It is well-settled that even a compound known to be desirable cannot
have been obvious without a known or obvious way of making the
compound. E.g., Hoeksema, 399 F.2d at 273. In our review of the Kim and
Berge references, we see no explicit disclosure of a method for making
hydrochloride or hydrobromide salts of Kim’s compounds, nor did the
rejection identify a preparation method in those references. On this record,
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Application 10/815,351

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we are compelled to agree with Appellant that the Answer’s belated general
reference to other patents showing allegedly “similar” methods is
insufficient to identify evidence that there was a reasonable expectation that
those patents would have enabled a person having ordinary skill to have
successfully made Appellant’s compounds. See Vaeck, 947 F.2d at 492.

CONCLUSION
The evidence of record is insufficient to conclude that a method of
making the claimed compounds was available, or would have been obvious,
at the time the invention was made.

SUMMARY
We reverse the rejection of claims 1-4 under 35 U.S.C. § 103(a) as
unpatentable over Kim and Berge.

REVERSED

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