Ex parte Brown

Board of Patent Appeals and Interferences

Feb 28, 2001

08273423 (B.P.A.I. Feb. 28, 2001)

1 Application for patent filed July 11, 1994. According to appellant, this application
is a continuation-in-part of application serial no. 07/943,853, filed September 11, 1992,
now abandoned, and a continuation-in-part of application serial no. 08/207,821, filed
March 7, 1994, now abandoned.
1
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for publication and is not binding precedent of the Board.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. 33
UNITED STATES PATENT AND TRADEMARK OFFICE
__________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________
Ex parte SANDRA BROWN
__________
Appeal No. 2000-0643
Application 08/273,4231
__________
HEARD: January 25, 2001
__________
Before WINTERS, SCHEINER and MILLS, Administrative Patent Judges.
SCHEINER, Administrative Patent Judge.
DECISION ON APPEAL
Appeal No. 2000-0643
Application 08/273,423
2 According to the Advisory Action (paper no. 16, mailed April 16, 1997), the
rejection of claims 1 through 16 under the first paragraph of 35 U.S.C. § 112 (as based on
a non-enabling disclosure), and the rejection of claims 15 and 16 under the second
paragraph of 35 U.S.C. § 112 have been withdrawn.
2
This is an appeal under 35 U.S.C. § 134 from the final rejection of claims 1
through 16, all the claims in the application. Claims 1 and 15 are representative and read
as follows:
1. A composition for the treatment of hair loss comprising effective amounts of:
a corticosteroid,
a Vitamin A derivative, and
a carrier agent for said corticosteroid and said Vitamin A derivative.
15. A method of treatment for hair restoration of a patient comprising the steps
of:
administering a corticosteroid to a hairless area of the skin of the
patient; and
administering a Vitamin A derivative to said hairless area of the
skin of the patient.
The references relied on by the examiner are:
Kligman 5,026,691 Jun. 25, 1991
Lesnik et al. (Lesnik), “Topical all-trans-retinoic acid prevents corticosteroid-induced skin
atrophy without abrogating the anti-inflammatory effect,” J. Am. Acad. Dermatol., Vol. 21,
pp. 186-190 (1989)
Bazzano et al. (Bazzano), “Effect of Retinoids on Follicular Cells,” J. Invest. Dermatol., Vol.
101, pp. 138S-142S (1993)
The claims stand rejected as follows:2
I. Claims 1 through 9 under 35 U.S.C. § 103 as unpatentable over Lesnik.
Appeal No. 2000-0643
Application 08/273,423
3
II. Claims 10 through 16 under 35 U.S.C. § 103 as unpatentable over Bazzano,
Kligman and Lesnik.
We reverse Rejection I, and affirm Rejection II.
DISCUSSION
Initially, we note the somewhat confusing statement on page 3 of the Brief regarding
the grouping of claims:
Claims 1-9 comprise one group. The claims of this group do not stand or fall
together. Claims 10-16 comprise a second group. The claims of this group
do not stand or fall together.
During the hearing on January 25, 2001, appellant’s counsel confirmed that the claims
within each group stand or fall together. Therefore, we shall limit our consideration of the
issues raised by this appeal as they pertain to independent claims 1 and 15.
Rejection I
Claim 1, which represents the claimed composition in its broadest aspect, is
directed to a composition comprising a carrier, a corticosteroid and a vitamin A derivative,
in amounts effective to treat hair loss.
Topical corticosteroids are used extensively to treat inflammatory skin disorders,
despite their numerous undesirable side effects (skin thinning, increased transparency,
telangiectasia, etc.). Lesnik investigates the ability of the vitamin A derivative, all-trans-
Appeal No. 2000-0643
Application 08/273,423
4
retinoic acid (RA), to prevent corticosteroid-induced skin atrophy without compromising
the anti-inflammatory properties of the steroids. Page 186.
The examiner cites a single example in Lesnik wherein betamethasone valerate
cream was applied to mouse skin “in the AM,” followed by RA “in the PM” (page 187,
column 1, paragraph 2) and concludes that “[o]ne of ordinary skill would have been
motivated to employ both agents together in a skin-treating composition since they are
known to be useful in a single therapeutic regimen for the treatment of the skin.”
In addition, we note that Lesnik describes other protocols, which differ from that
cited by the examiner, in that RA is administered immediately after fluocinolone acetonide
or triamcinolone acetonide (both of which are corticosteroids). Regardless of the timing,
administration of RA prevents corticosteroid-induced skin atrophy. Further examples
demonstrate that administration of RA does not interfere with the anti-inflammatory effects
of the corticosteroids. Page 187. Thus, applying a corticosteroid and RA together would
not appear to present a problem, and the examiner’s proposed reason for combining them
in a single composition for the treatment of inflammatory skin disorders seems plausible at
first blush.
Nevertheless, claim 1 requires a composition containing a corticosteroid and a
Vitamin A derivative in amounts effective for the treatment of hair loss. The examiner
touches on this briefly; on the one hand dismissing the recitation “for the treatment of hair
loss” as a mere statement of intended use, while on the other hand asserting that “[t]he
Appeal No. 2000-0643
Application 08/273,423
5
optimization of amounts of ingredients is deemed within the skill of the artisan.”
Examiner’s Answer, pages 3 and 2, respectively.
The question that comes to mind is, optimization for what? Contrary to the
examiner’s assertion, the recitation “effective amounts” coupled with the recitation “for the
treatment of hair loss” confers a functional limitation on the claimed composition; in this
case, the preamble of the claim is not merely a statement of intended use. The examiner
does not allege that the levels of corticosteroid and RA in Lesnik’s examples, would, if
combined, be effective in treating hair loss. Nor has the examiner explained why one
skilled in the art would optimize, or adjust, the corticosteroid and RA amounts used in
Lesnik to levels effective to treat hair loss, when Lesnik does not mention hair loss at all.
35 U.S.C. § 103 requires that obviousness be determined based on the claimed
subject matter as a whole. Where, as here, the determination of obviousness is based on
less than the entire claimed subject matter, the examiner’s conclusion of obviousness is
unsound and cannot stand. On this record, we hold that the examiner has not established
a prima facie case of obviousness for claim 1, the broadest of the composition claims; that
being the case, we are constrained to reverse the examiner’s rejection of claims 1 through
9 under 35 U.S.C. § 103 as unpatentable over Lesnik.
Rejection II
Appeal No. 2000-0643
Application 08/273,423
6
Claim 15, directed to a “method of treatment for hair restoration” comprising
administering a corticosteroid and a Vitamin A derivative to hairless skin, stands rejected
as unpatentable over Kligman, Bazzano and Lesnik.
Bazzano teaches that topical application of all-trans-retinoic acid alters the hair-
growth cycle in the C3H mouse model by prolonging the anagen phase and shortening the
telogen phase. According to the reference, “[t]his effect is similar to the effect of minoxidil
on the hair cycle dynamics in this animal model.” Abstract.
Kligman discloses a method of treating alopecia (hair loss) comprising topical
application of a composition comprising minoxidil and a corticosteroid to affected areas of
the human scalp. According to Kligman, the method prevents the “chronic inflammatory
process, subtending to the hair bulbs, in patterned alopecia, [which] lead[s] to eventual
scarring of the lower follicle, making regrowth impossible.” Abstract, and the paragraph
bridging columns 3 and 4. In addition, we note that Kligman reports that “[t]he use of
retinoids alone or in combination with minoxidil . . . to increase hair growth” is known.
Paragraph bridging columns 2 and 3.
We agree with the examiner that it would have been obvious for one skilled in the
art “to employ corticosteroids and all-trans-retinoic acid together in a single hair loss
treatment since each was known separately for the same purpose.” Examiner’s Answer,
page 3. (“[T]he idea of combining them flows logically from their having been individually
taught in the in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072
Appeal No. 2000-0643
Application 08/273,423
3 Declaration of Alan H. Greenspan, M.D., executed March 18, 1997 (page 5,
paragraph 21).
7
(CCPA 1980)). Moreover, in our view, one skilled in the art would have had a reasonable
expectation that Kligman’s corticosteroids and Bazzano’s all-trans-retinoic acid would
complement each other, as corticosteroids and minoxidil do, inasmuch as Bazzano
suggests that all-trans-retinoic acid and minoxidil have similar effects on hair cycle
dynamics.
The matter does not end here, however. As stated in In re Hedges, 783 F.2d 1038,
1039, 228 USPQ 685, 686 (Fed. Cir. 1986):
If a prima facie case is made in the first instance, and if the applicant comes
forward with reasonable rebuttal, whether buttressed by experiment, prior art
references, or argument, the entire merits of the matter are to be reweighed.
In re Piasecki, 745 F.2d 1468, 1472, 223 USPQ 785, 788 (Fed. Cir. 1984).
Appellant argues that “experimental evidence . . . encompassing two double blind
studies unequivocally shows the unexpected results of Applicant’s claimed . . . method to
treat alopecia.” Brief, page 12. The results of the two double blind studies, in which a
corticosteroid and a vitamin A derivative were administered together, are reported and
analyzed in the declarations of Drs. Alan H. Greenspan and Jules T. Mitchel. The
declarants concluded that the results “are suggestive of treatment efficacy,”3 i.e., that the
combination “display[s] a favorable trend toward hair growth for patients diagnosed with . .
. male pattern baldness, and is potentially effective in the treatment of male pattern
Appeal No. 2000-0643
Application 08/273,423
4 Declaration of Dr. Jules T. Mitchel, executed September 2, 1995 (page 3,
paragraph 22).
8
alopecia.”4 The issue, however, is whether the “favorable trend toward hair growth”
attributed to administering all-trans-retinoic acid and a corticosteroid would have been
unexpected.
Appellant’s burden to make adequate rebuttal under these circumstances is
described in In re Freeman, 474 F.2d 1318, 1324, 177 USPQ 139, 143 (CCPA 1973):
In order for a showing of “unexpected results” to be probative evidence of
non-obviousness, it falls upon the applicant to at least establish: (1) that there
actually is a difference between the results obtained through the claimed
invention and those of the prior art: and (2) that the difference actually
obtained would not have been expected by one skilled in the art at the time
of the invention (citations omitted).
To the extent that appellant relies on the results of the two double blind studies to
demonstrate a difference between the invention and the prior art, we are not persuaded.
Appellant acknowledges that at least one of the components used in the claimed method
is recognized as promoting hair growth (“[Bazzano] does teach that retinoic acid has utility
in promoting hair growth” Brief, page 8). Nevertheless, in each of the double blind studies
described in the declarations, the effect of administering all-trans-retinoic acid in
combination with a corticosteroid is compared with the effect of administering a placebo.
It cannot be established from these results whether there is any difference between
administering the combination and administering all-trans-retinoic acid alone, much less
whether any difference, if it exists, would have been unexpected. Having carefully reviewed
Appeal No. 2000-0643
Application 08/273,423
9
the evidence of record and appellant’s arguments, we find no error in the examiner’s
conclusion that the evidence relied on by appellant is insufficient to overcome the prima
facie case of obviousness.
On this record, we find no error in the examiner’s determination that claim 15 is
unpatentable under 35 U.S.C. § 103. As previously indicated, claims 10 through 14 and
16 fall with claim 15. Accordingly, the rejection of claims 10 through 16 under 35 U.S.C. §
103 is affirmed.
CONCLUSION
We have affirmed Rejection II of claims 10 through 16 under 35 U.S.C. § 103, and
reversed Rejection I of claims 1 through 9 under the same section of the statute. BY our
action today, claims 1 through 9 are free of rejection.
No time period for taking any subsequent action in connection with this appeal may
be extended under 37 CFR § 1.136(a).
AFFIRMED-IN-PART
)
Sherman D. Winters )
Appeal No. 2000-0643
Application 08/273,423
10
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Toni R. Scheiner )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Demetra Mills )
Administrative Patent Judge )
Gifford, Krass, Groh, Sprinkle,
Anderson & Citkowski, P.C.
280 North Old Woodward Avenue, Suite 400
Birmingham, Michigan 48009-5394