Ex parte Zeligs

Board of Patent Appeals and Interferences

Feb 22, 1999

07845560 (B.P.A.I. Feb. 22, 1999)

Application for patent filed March 4, 1992. 1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not
written for publication in a law journal and (2) is not binding precedent of the
Board.
Paper No. 27
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte MICHAEL A. ZELIGS
____________
Appeal No. 95-2688
Application No. 07/845,5601
____________
ON BRIEF
____________
Before WINTERS, JOHN D. SMITH, and WALTZ, Administrative Patent Judges.
JOHN D. SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal pursuant to 35 U.S.C. § 134 from the final rejection of claims
1-49 and 83-90.
The subject matter on appeal relates to compositions and methods of using
dehydroepiandrosterone (DHEA) and its derivatives in combination with vitamin A
Appeal No. 95-2688
Application No. 07/845,560
2
derivatives (retinoids) for the treatment and prevention of disorders of epithelial tissues.
Representative composition claim 1 is reproduced below:
1. A composition for the treatment of epithelial damage in a mammal comprising a
pharmacologically active retinoid and pharmacologically active DHEA wherein the
combination is effective in preventing or reversing damage to the epithelium due to
environmental oxidative agents and wherein the proportion of retinoid and DHEA is
sufficient to overcome the undesirable side effects of each composition when used alone.
The references of record relied upon by the examiner are:
Orentreich (Orentreich '556) 4,496,556 Jan. 29, 1985
Orentreich (Orentreich '129) 4,542,129 Sep. 17, 1985
Kligman et al. (Kligman) 4,889,847 Dec. 26, 1989
References of record relied upon by the appellant are:
Greenspan (Editor), "Disorders of Adrenal Cortex," in
Review of Endocrinology , Lange, 818, 819 and 275, undated publication.
Martin Bohl et al (Editor), "Molecular Structure and Biological Activity of Steroids" 2, 3, 4,
16, 17 (Boca Raton, FL, CRC Press, 1992).
Louis S. Goodman et al., Chap. 60 "Adrenocortical Steroids: "Inhibitors of Synthesis," in
60 Goodman and Gilman's The Pharmacological Basis of Therapeutics", 554-557 (8th
ed., New York, Pergamon Press, 1990).
Emil L. Smith et al., PRINCIPLES OF BIOCHEMISTRY: Mammalian Biochemistry 498-567
(7th ed., New York, McGraw-Hill Book Company, undated publication).
Mary May et al.(May), "PROTECTION FROM GLUCOCORTICOID INDUCED THYMIC
INVOLUTION BY DEHYDROEPIANDROSTERONE," 46 Life Sciences, 1627-1631
(1990).
Raymond A. Daynes et al., "Regulation of murine lymphokine production in vivo II.
Dehydroepiandrosterone is a natural enhancer of interleukin 2 synthesis by helper T
cells*," 20 Eur. I. Immunol. 793-802 (1990).
Appeal No. 95-2688
Application No. 07/845,560
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Arthur G. Schwart et al., "Novel Dehydroepiandrosterone Analogues with Enhanced
Biological Activity and Reduced Side Effects in Mice and Rats, " 48, Cancer Research1
4817-4822 (1988)
The appealed claims stand rejected for obviousness (35 U.S.C. § 103) over
Kligman in view of the Orentreich patents.
We cannot sustain the stated rejection.
OPINION
The examiner's rejection of the appealed claims is predicated on his assertion that
it would have been obvious to a person of ordinary skill in this art to substitute “the DHEA
of the secondary references for the steroids" of Kligman "in view of their similar activity and
structure," thereby arriving at the claimed invention, since Kligman teaches a "composition
containing steroids and retinoids" (answer, page 3).
Initially, we point out that Kligman's disclosure is directed to compositions
containing glucocorticoids, not steroids in a generic sense, as held by the examiner.
Secondly, the examiner has provided no factual support for the contention that
glucocorticoids and DHEA have similar activity and structure. Indeed, as appellant has
argued, glucocorticoids and DHEA are chemically distinct and are not functionally
equivalent, and appellant has cited multiple publications in this record in support of his
assertions. In this regard, the May publication relied upon by appellant indicates that
Appeal No. 95-2688
Application No. 07/845,560
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DHEA blocks the effects of glucocorticoids on the immune system. See May at page 1628.
Accordingly, the stated rejection of the appealed claims is reversed.
OTHER ISSUES
In the answer at page 3, the examiner states that no new ground of rejection has
been imposed in the answer. The examiner then proceeds to raise a new rationale for the
rejection of the appealed claims based on the holding of In re Kerkhoven, 626 F.2d 848,
850, 205 USPQ 1069, 1072, (CCPA 1980) that it is prima facie obvious to combine two
compositions each of which is taught by the prior art to be useful for the same purpose, in
order to form a third composition which is to be used for the very same purpose.
According to the examiner, the instant claims define nothing more than the concomitant
use of two conventional epithelial damage medicaments. See the answer at page 5. As
evidence of the "conventional" individual use of DHEA and retinoids, the examiner refers
to the respective disclosures of Kligman at column 2, lines 19-30, and Orentreich '551 at
column 2, lines 56-63.
Appellant has not responded to the specific theory of rejection based on the In re
Kerkhoven rationale. However, since this rationale was not set forth in the examiner's final
rejection, it constitutes a new ground of rejection, notwithstanding the examiner's
contention that no new rejection was stated in the answer. On these facts, the Kerkhoven
issue has not been properly joined.
Appeal No. 95-2688
Application No. 07/845,560
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This application is remanded to the examiner to reconsider the issues raised by the
Kerkhoven theory of rejection in light of the following. Orentreich '556 teaches the use of
DHEA to prevent and/or treat dry skin (xeroderma) and loss of natural oiliness. See this
reference at column 1, lines 12-16 and column 2, lines 56-58. Xeroderma or xerosis is
defined as the pathologic dryness of skin. See Stedman's Medical Dictionary, 24th ed.,
Williams & Wilkins, page 1582, copyright 1982, copy attached. Vitamin A (retinoic acid)
has been recommended for the treatment of xerosis (asteatosis). See Modern
Dermatology and Syphilology, 2nd ed., pages 65-69, copyright 1947, copy attached.
However, retinoic acid topical therapy is said to often cause dryness of the skin. See
appellant's specification at page 3, lines 6-17.
In light of the above disclosures and upon reconsideration of the entire record, the
examiner is required to reweigh all disclosures (inclusive of the fact that retinoic acid
therapy often causes dryness of the skin) which are relevant to a rejection based on the
grounds that DHEA and vitamin A (retinoic acid) have been individually used for "the very
same purpose" as required by the holding in In re Kerkhoven. Upon reweighing all the
relevant facts in this record, the examiner should restate a rejection of appealed claim 1, if
appropriate. Consideration of a rejection to any other appealed claim should be made on
a claim-by-claim basis.
Appeal No. 95-2688
Application No. 07/845,560
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In summary, the decision of the examiner is reversed. This application is remanded
to the examiner for reconsideration of the above issues.
This application, by virtue of its "special" status requires an immediate action.
Manual of Patent Examining Procedure § 708.01(d) (7th ed., July 1998). It is important
that the Board be informed promptly of any action affecting the appeal in this case.
REVERSED/REMANDED
SHERMAN D. WINTERS )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
JOHN D. SMITH ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
THOMAS A. WALTZ )
Administrative Patent Judge )
lp
Appeal No. 95-2688
Application No. 07/845,560
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JANICE A. SHARP
MERCHANT GOULD, SMITH, EDELL, WELTER & SCHMIDT
11150 SANTA MONICA BLVD., SUITE 400
LOS ANGELES, CALIFORNIA 90025-3395
Leticia
Appeal No. 95-2688
Application No. 07/845,560
APJ JOHN D. SMITH
APJ WINTERS
APJ WALTZ
DECISION: REVERSED/REMANDED
Send Reference(s): Yes No
or Translation (s)
Panel Change: Yes No
Index Sheet-2901 Rejection(s):103
Prepared: July 25, 2000
Draft Final
3 MEM. CONF. Y N
OB/HD GAU: 1205
PALM / ACTS 2 / BOOK
DISK (FOIA) / REPORT