Ex Parte Loria

Board of Patent Appeals and Interferences

Apr 26, 2004

09794531 (B.P.A.I. Apr. 26, 2004)

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for publication and is not binding precedent of the Board.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. 25

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ROGER M. LORIA
__________

Appeal No. 2004-0761
Application No. 09/794,531
__________

ON BRIEF
__________

Before ADAMS, GRIMES, and GREEN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1-18 and 27-80. Claims 19-26 are also pending but have
been withdrawn from consideration. Claim 1 is representative and reads as
follows in the attached appendix.
The examiner relies on the following references:
Loria WO 97/37662 Oct. 16, 1997
Berkow, Merck Manual of Diagnosis and Therapy, 16th ed., pp. 1750-1751 (1992)
Claims 1-18 and 27-80 stand rejected under 35 U.S.C. § 103.
We reverse.
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Background
”∆5-Androstenediol (AED) is a naturally-occurring metabolite of
dehydroepiandrosterone (DHEA), the most abundant product of the adrenal
glands. . . . AED exists in two epimeric forms: ∆5-androstene-3-β,17α-diol
(αAED) and ∆5-androstene-3-β,17β-diol (βAED). . . . βAED has
immunostimulating properties and immune upregulating properties. αAED has
been shown to induce apoptosis in transformed cells in vitro.” Specification,
page 2.
Discussion
Claim 1, the broadest claim on appeal, is directed to a two-step method of
treating cancer (or precancer, or metastatic cancer). In the first step of the
claimed method, αAED or an ether or ester derivative thereof is administered to
the patient, and in a second, subsequent step, βAED or an ether or ester
derivative is administered.
The examiner rejected all of the claims as obvious in view of Loria and
Berkow. The examiner cited Berkow, however, only for its teaching that
“aminoglutethimide and orchiectomy are useful in treating prostate cancer.”
Examiner’s Answer, page 5. This teaching seems to be relevant only to certain
dependent claims, and therefore we need not discuss Berkow further.
The examiner cited Loria’s teachings that αAED inhibits tumor growth, and
that the combination of αAED and βAED inhibited proliferation of breast cancer
cells in vitro. See the Examiner’s Answer, page 4. The examiner also noted that
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Application No. 09/794,531

Loria “teaches that βAED can enhance immune response, and [is] also useful in
counteracting the untoward effects of irradiation and chemotherapy.” Id.
The examiner conceded that “Loria does not expressly teach the
compounds are administered in a subsequent manner,” id., but asserted that “the
optimization of therapeutic effect parameters (e.g., dosing regimens) is obvious
as being within the skill of the artisan.” Id., page 5. See also page 7:
“[A]djusting and optimizing the timing and administration order of the compounds
would be obvious as being within the purview of the skilled artisan.”
Appellant argues that the cited references would not have suggested the
claimed method of sequentially administering αAED and βAED. See the Appeal
Brief, pages 8-9: “[T]he activity of the combination of αAED alone or the activity
of αAED and βAED does not suggest using αAED and βAED sequentially. If
anything, it suggests that αAED and βAED should be used in combination and
not sequentially. Therefore, Loria does not suggest treating cancer using
sequential administration of αAED and βAED. . . . Berkow does not provide any
teaching or suggestion related to the administration of αAED and βAED.”
“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, 28 USPQ2d 1955, 1956 (Fed. Cir.
1993).
In considering whether a claimed invention would have been obvious at
the time it was made, examiners must be careful to avoid interpreting the
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Application No. 09/794,531

references in light of the later-filed patent application. See In re Dembiczak, 175
F.3d 994, 999, 50 USPQ2d 1614, 1617 (Fed. Cir. 1999): “Measuring a claimed
invention against the standard established by section 103 requires the oft-difficult
but critical step of casting the mind back to the time of invention, to consider the
thinking of one of ordinary skill in the art, guided only by the prior art references
and the then-accepted wisdom in the field.” In the words of Judge Learned
Hand, obviousness is “the creature of an imagination projected upon the future
out of materials from the past.” Schaefer, Inc. v. Mohawk Cabinet Co., Inc., 276
F.2d 204, 207, 125 USPQ 318, 320 (2d Cir. 1960).
To show that a claimed invention would have been prima facie obvious,
the examiner must provide evidence that the prior art would have suggested the
invention as a whole to those of ordinary skill in the art. “Most if not all inventions
arise from a combination of old elements. Thus, every element of a claimed
invention may often be found in the prior art. However, identification in the prior
art of each individual part claimed is insufficient to defeat patentability of the
whole claimed invention. Rather, to establish obviousness based on a
combination of the elements disclosed in the prior art, there must be some
motivation, suggestion or teaching of the desirability of making the specific
combination that was made by the applicant.” In re Kotzab, 217 F.3d 1365,
1369-70, 55 USPQ2d 1313, 1316 (Fed. Cir. 2000).
In this case, we agree with Appellant that the examiner has not adequately
explained how the cited references would have suggested the method defined by
claim 1 to a person of ordinary skill in the art reading them without the benefit of
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Application No. 09/794,531

the instant specification. In particular, the examiner has pointed to nothing in the
prior art that would have led those of skill in the art to administer first αAED and
then, subsequently, βAED.
The examiner pointed out that Loria teaches that the combination of αAED
and βAED was effective in vitro for inhibiting the growth of breast cancer cells
(Example 2). Loria also teaches, however, that the two epimers have different
activities when used separately. See page 7, lines 4-13: At concentration[s] of
nM or greater, the αAED significantly inhibited the growth of ZR-75-1 [breast
cancer] cells. . . . As opposed to αAED, the βAED alone at 100 nM
concentrations did not have any antiproliferative effect on the growth of the ZR-
75-1 cells.”
The examiner cannot rely on a conclusory statement that “optimization of
therapeutic effect parameters (e.g., dosing regimens) is obvious as being within
the skill of the artisan,” in order to make up for deficiencies in the prior art. It is
true that “discovery of an optimum value of a result effective variable in a known
process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276,
205 USPQ 215, 219 (CCPA 1980). That rule, however, applies only where the
variable being optimized is one that is known to affect the results of the particular
process; i.e., the knowledge that the variable is result-affecting provides the
motivation to optimize it. The examiner has pointed to no evidence of record
showing that those of skill in the art would have been motivated to add a
subsequent step of administering βAED in order to “optimize” the known process
of inhibiting tumor cell growth by administering αAED.
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Application No. 09/794,531

Summary
The references cited by the examiner do not support a prima facie case of
obviousness. The rejection under 35 U.S.C. § 103 is reversed.

REVERSED

Donald E. Adams )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Eric Grimes )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

EG/jlb
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Application No. 09/794,531

Parker and Destefano
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APPENDIX