Ex Parte Hersh

Board of Patent Appeals and Interferences

Sep 26, 2002

08781868 (B.P.A.I. Sep. 26, 2002)

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for publication and is not binding precedent of the Board.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. 20

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte THEODORE HERSH M.D.
__________

Appeal No. 2001-1177
Application No. 08/781,868
__________

ON BRIEF
__________

Before ADAMS, MILLS, and GRIMES, 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 35-54, all of the claims remaining. Claims 35, 36, 39-43,
and 45 are representative and read as follows:
35. A composition for enhancing repair from free radical damage to
skin as a result of treatment of the skin with exfoliants,
chemosurgery or laser therapy comprising as active ingredients
glutahione and selenoamino acid in amounts suitable for enhancing
repair of skin from free radical damage, said active ingredients
being combined with a suitable carrier for topical application.
Appeal No. 2001-1177 Page 2
Application No. 08/781,868

36. The composition of claim 35 further comprising acetyl-L-carnitine.

39. The composition of claim 35 further comprising epidermal growth
factor.
43. The composition of claim 35 further comprising tissue respiratory
factor.

45. A method for enhancing repair from free radical damage to skin as
a result of treatment of the skin with exfoliants, chemosurgery or
laser therapy comprising topically applying active ingredients in a
suitable topical carrier to skin damaged by exfoliants,
chemosurgery or laser therapy, said active ingredients comprising
glutathione and selenoamino acid in amounts suitable for
enhancing repair of skin from free radical damage.

The examiner relies on the following references:
Levin 4,942,031 Jul. 17, 1990
Spector et al. (Spector) 5,128,365 Jul. 7, 1992
Burke 5,330,757 Jul. 19, 1994
Finkenaur et al. (Finkenaur) 5,427,778 Jun. 27, 1995
N’Guyen et al. (N’Guyen) 5,516,507 May 14, 1996
Piazza et al. (Piazza) 5,565,439 Oct. 15, 1996
Otsu et al. (Otsu) 5,582,817 Dec.10, 1996
Cavazza et al. (Cavazza) 5,627,212 May 6, 1997
Hersh et al. (Hersh) 5,667,791 Sep. 16, 1997

Claims 35, 36, and 38 stand rejected for obviousness-type double
patenting over claims 1, 3, and 5-7 of Hersh.
Claims 35-54 stand rejected under 35 U.S.C. § 102(e) as anticipated by
Hersh.
Claims 35, 37, 38, and 44 stand rejected under 35 U.S.C. § 103 as
obvious in view of N’Guyen and Burke.
Claims 36 and 39-43 stand rejected under 35 U.S.C. § 103 as obvious in
view of N’Guyen and Burke, combined with one of the following references:
Cavazza, Piazza, Otsu, Levin, Finkenauer, or Spector.
Appeal No. 2001-1177 Page 3
Application No. 08/781,868

Claims 45-54 stand rejected under 35 U.S.C. § 103 as obvious in view of
N’Guyen, Burke, Cavazza, Piazza, Otsu, Levin, Finkenauer, and Spector.
We affirm the rejection of the composition claims (claims 35-44) but
reverse the rejection of the method claims (claims 45-54).
Background
“Skin peeling programs (chemical or thermal peels) are designed to
remove ‘dead’ skin with the aim of being replaced by new, clearer and younger
cells yielding smooth and firmer skin.” Specification, page 1. Such therapies are
used to treat, among other things, sun-damaged skin and fine lines. See id.
However, these therapies can also result in damage to the skin, resulting from
the generation of free radicals. See id., page 8.
The specification discloses “a composition and method for reducing the
cutaneous effects and complications of chemosurgery and laser therapy of
induced skin damage. The composition comprises an effective amount of a
glutathione and selenoamino acid since selenium is a co-factor of glutathione
peroxidase.” Page 13. The specification also discloses that the “composition
can be formulated as a lotion containing from about 0.01% to 10% of the above
described active ingredients.” Page 27. The specification discloses several
exemplary compositions that contain 0.03% glutathione and 0.03%
selenomethionine. See pages 28-29 (“reparative hand and nail formula”), 32-33
(“protein gel masque”), 34-35 (“sunburn lotion”), 37-38 (“sun gel”), and 38-40
(“reparative cream”).
Appeal No. 2001-1177 Page 4
Application No. 08/781,868

Discussion
According to Appellant, the composition claims stand or fall together and
the method claims stand or fall together. See the Appeal Brief, page 5.
Therefore, where multiple claims have been rejected on the same basis, we have
considered claim 35 as representative of the composition claims and claim 45 as
representative of the method claims. See 37 CFR § 192(c)(7).
1. Obviousness-type double patenting
The examiner rejected claims 35, 36, and 38 under the judicially-created
doctrine of obviousness-type double patenting, on the basis that these claims are
not patentably distinct from claims 1, 3, and 5-7 of Appellant’s issued patent
5,677,791 (“Hersh”). We agree. Instant claim 35 is directed to a composition
comprising glutathione and selenoamino acid “in amounts suitable for enhancing
repair of skin from free radical damage.” The specification states that the
claimed “composition can be formulated as a lotion containing from about 0.01%
to 10% of the above described active ingredients.” Page 27. The specification
also provides exemplary compositions containing 0.03% glutathione and 0.03%
selenomethionine.
Claim 1 of Hersh is directed to a composition for topical application
comprising at least 0.01% selenomethionine and at least 0.03% glutathione.
Thus, the instantly claimed composition and Hersh’s compositions contain the
same ingredients in the same amounts. Instant claim 35 is therefore anticipated
Appeal No. 2001-1177 Page 5
Application No. 08/781,868

by the composition of Hersh’s claim 1 and a rejection for obviousness-type
double patenting is appropriate. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d
955, 968, 58 USPQ2d 1869, 1878 (Fed. Cir. 2001) (“A later . . . claim is not
patentably distinct from an earlier patent claim if the later claim is obvious over,
or anticipated by, the earlier claim.”). See also In re Goodman, 11 F.3d 1046,
1053, 29 USPQ2d 2010, 2016 (Fed. Cir. 1993) (“[The application claims] are
generic to the species of invention covered by claim 3 of the patent. Thus, the
generic invention is ‘anticipated’ by the species of the patented invention. This
court’s predecessor has held that, without a terminal disclaimer, the species
claims preclude issuance of the generic application.” (citation and footnote
omitted)).
Appellant argues that “[a]lthough the composition of applicant’s own ‘791
patent and those described herein are similar, they are used for a different
purpose. . . . From a compositional standpoint, the amounts of ingredients
oftentimes vary as well as the type of carrier as the intended purpose for these
compositions are completely unrelated.” Appeal Brief, page 6.
This argument is not persuasive. It is true that the patent’s claims are
directed to a “composition for protection from x-ray induced skin damage,” while
the instant claims are directed to a “composition for enhancing repair from free
radical damage to skin as a result of treatment of the skin with exfoliants,
chemosurgery or laser therapy.” The difference in the preambles of the claims,
however, merely reflects the intended use of the compositions. The preamble
language therefore does not distinguish the patented composition from that of the
Appeal No. 2001-1177 Page 6
Application No. 08/781,868

instant claims. See Pitney Bowes Inc. v. Hewlett Packard Co., 182 F.3d 1298,
1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999): “If . . . the body of the claim
fully and intrinsically sets forth the complete invention, including all of its
limitations, and the preamble offers no distinct definition of any of the claimed
invention’s limitations, but rather merely states, for example, the purpose or
intended use of the invention, then the preamble is of no significance to claim
construction.”
Appellant has presented no evidence that a composition comprising a
topical carrier and, e.g., 0.03% glutathione and 0.03% selenomethionine, when
used to enhance repair of skin following chemosurgery or laser therapy, would
differ from the same composition when used to protect skin from x-ray induced
damage. In this regard, we note that both the patent and the instant application
disclose exemplary “reparative cream” compositions that contain apparently
identical ingredients. See Hersh, column 13, line 50 to column 14, line 26, and
the instant specification, pages 38-40.
2. Anticipation
The examiner also rejected all of the instant claims as anticipated by
Hersh. The examiner characterized Hersh as disclosing the same compositions
as are presently claimed, as well as a method of using such compositions to treat
the skin. See the Examiner’s Answer, page 4.
“Under 35 U.S.C. § 102, every limitation of a claim must identically appear
in a single prior art reference for it to anticipate the claim.” Gechter v. Davidson,
116 F.3d 1454, 1457, 43 USPQ2d 1030, 1032 (Fed. Cir. 1997). “[E]very
Appeal No. 2001-1177 Page 7
Application No. 08/781,868

limitation positively recited in a claim must be given effect in order to determine
what subject matter that claim defines. However, recitation, in a claim to a
composition, of a particular property said to be possessed by the recited
composition, be that property newly-discovered or not, does not necessarily
change the scope of the subject matter otherwise defined by that claim.” In re
Wilder, 429 F.2d 447, 450, 166 USPQ 545, 548 (CCPA 1970). “It is well settled
that the recitation of a new intended use for an old product does not make a
claim to that old product patentable.” In re Schreiber, 128 F.3d 1473, 1477, 44
USPQ2d 1429, 1431 (Fed. Cir. 1997).
In this case, we agree with the examiner that Hersh anticipates the
composition claims of the present application. Hersh discloses compositions
comprising glutathione and selenoamino acids (e.g., selenomethionine) for
topical treatment of skin. See, e.g., column 13, line 50 to column 14, line 26. As
discussed above, Hersh’s exemplary “reparative cream” appears to be identical
to the working example in the present specification. Hersh’s reparative cream
composition comprises 0.03% glutathione and selenomethionine, the same
concentration of these ingredients used in the working examples of the present
specification. Thus, the prior art compositions appear to comprise glutathione
and a selenoamino acid “in amounts suitable for enhancing repair of skin from
free radical damage,” as required by the present claims. Claims 35-44 are
anticipated by Hersh.
We do not find, however, that Hersh anticipates the method claims of the
present application. Hersh does not teach using the disclosed compositions to
Appeal No. 2001-1177 Page 8
Application No. 08/781,868

treat patients who have been subjected to exfoliation, chemosurgery, or laser
therapy. Thus, Hersh does not disclose all of the limitations of the method
claims.
With regard to the composition claims, Appellant “fully concurs that the
compositions are similar,” but argues that “the end uses of these compositions
are not similar.” Appeal Brief, page 6. Appellant argues that “[t]he preamble[s] of
the composition claims differ dramatically as the reference is directed to
protecting the skin from the ill effects of x-ray radiation while the present claims
are directed to enhancing repair from free radical damage to the skin as a result
of treatment of the skin with exfoliants, chemosurgery or laser therapy.” Id.,
pages 6-7.
This argument is not persuasive. It is true, of course, that the preamble of
the present claims differs from the preamble of the patent’s claims. However, as
discussed above, the preamble of the composition claims does not limit the
claimed composition because it merely recited a purpose or intended use of the
composition; it does not add any limitations to those in the body of the claims.
Therefore, the preamble does not change the scope of the claims.
For the reasons discussed above, the rejection under 35 U.S.C. § 102(e)
is affirmed with respect to claims 35-44 and reversed with respect to claims
45-54.
Appeal No. 2001-1177 Page 9
Application No. 08/781,868

3. Obviousness
The examiner rejected all of the composition claims as obvious over
N’Guyen and Burke, or N’Guyen and Burke in combination with one of six other
references. The examiner also rejected all of the method claims as obvious over
N’Guyen, Burke, and all six of the other references relied on with respect to the
method claims.
A. N’Guyen and Burke
The examiner rejected claims 35, 37, 38, and 44 as obvious over N’Guyen
and Burke. The examiner noted that N’Guyen discloses topical compositions
comprising glutathione for treating or preventing cutaneous aging, while Burke
discloses topical compositions comprising selenoamino acids for treating skin
damage caused by UV irradiation. Examiner’s Answer, pages 5-6. Burke
discloses that the “cumulative damage caused by UV irradiation is denoted in the
medical dermatologic literature as ‘photoaging’ and is manifested clinically by
wrinkles [and] dry, waxy skin.” Column 1, lines 25-28. The examiner concluded
that these teachings would have rendered the presently claimed compositions
prima facie obvious.
“In proceedings before the Patent and Trademark Office, the Examiner
bears the burden of establishing a prima facie case of obviousness based upon
the prior art. ‘[The Examiner] can satisfy this burden only by showing some
objective teaching in the prior art or that knowledge generally available to one of
ordinary skill in the art would lead that individual to combine the relevant
teachings of the references.’” In re Fritch, 972 F.2d 1260, 1265, 23 USPQ2d
Appeal No. 2001-1177 Page 10
Application No. 08/781,868

1780, 1783 (Fed. Cir. 1992) (citations omitted). “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. . . . [T]he idea of combining them flows logically from their
having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846,
850, 205 USPQ 1069, 1072 (CCPA 1980).
Here, we agree that N’Guyen and Burke render the composition of
claim 35 prima facie obvious. N’Guyen and Burke teach compositions for
treating skin aging and comprising glutathione and selenoamino acids,
respectively. It would have been obvious to combine the active ingredients of the
two compositions to make a third composition for treating skin aging, and
comprising both glutathione and selenoamino acids.
Appellant concedes that N’Guyen and Burke “relate equally to
compositions to repair cutaneous aging, called photoaging, by known
dermatologic processes.” Appeal Brief, page 8. He argues, however, that the
references do not support a prima facie case because they do not teach use of
the disclosed compositions “for the repair of damage to the skin from chemical
peels and thermal injury of laser surgery.” Id., page 9.
This argument is not persuasive. As discussed above, claim 35 is
directed to a composition and the preamble’s recitation of the intended use of
that composition does not limit the scope of the claimed composition. The prior
art renders obvious a composition within the scope of claim 35, albeit for a
Appeal No. 2001-1177 Page 11
Application No. 08/781,868

different use, and therefore claim 35 is unpatentable under 35 U.S.C. § 103.
Claims 37, 38, and 44 fall with claim 35.
B. N’Guyen, Burke, and Levin
The examiner rejected claim 43 as obvious over N’Guyen, Burke, and
Levin. Claim 43 is directed to the composition of claim 35, with the additional
component tissue respiratory factor. As the examiner noted, Levin teaches
topical compositions comprising tissue respiratory factor for treating skin
wrinkles, among other things. See Levin, column 1, lines 34-35 and 65-68. The
examiner concluded that it would have been obvious to combine the tissue
respiratory factor disclosed by Levin with the composition comprising glutathione
and selenoamino acids taught by the combination of N’Guyen and Burke.
We agree. Levin teaches that tissue respiratory factor is useful in treating
skin wrinkles, and Burke teaches that wrinkles are one of the symptoms of
photoaging. Thus, it would have been obvious to combine Levin’s tissue
respiratory factor with the composition suggested by N’Guyen and Burke. See
Kerkhoven, 626 F.2d at 850, 205 USPQ at 1072 (“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.”).
Appellant argues that “Levin teaches a topical composition including an
anti-inflammatory agent and live yeast cell derivative to ameliorate the neuralgic
pain associated with herpes infection when applied to an area of the skin
proximate the pain. Once again, the combination of Levin with the principal
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Application No. 08/781,868

references of N’Guyen and Burke represents a classic case of hindsight.”
Appeal Brief, page 13. Appellant also argues that “even if such a composition
was to be made, the composition, taken as a whole, would teach nothing about
applicant’s composition.” Id.
This argument is not persuasive. First, Levin teaches that “live yeast cell
derivative” is another name for tissue respiratory factor. See column 1, lines
21-24 (“LYCD as utilized herein . . . is the acronym for Live Yeast Cell Derivative.
The material is also known as . . . Tissue Respiratory Factor (TRF).”). Levin also
teaches that tissue respiratory factor is “suitable for the treatment of various
ailments and physical conditions of the skin such as . . . wrinkles.” Column 1,
lines 65-68. See also column 12, lines 1-62 (headed “Anti-Skin Wrinkling
Compositions”). Thus, we do not agree with Appellant’s characterization of Levin
as limited to compositions for treating pain associated with herpes virus
infections.
Nor do we agree that the references could only be combined with the
benefit of hindsight. As discussed above, all of the references disclose topical
compositions for treating skin aging or a symptom thereof. It would therefore
have been obvious to combine the active ingredients of the three prior art
compositions in order to create a topical composition for treating skin aging
comprising glutathione, selenoamino acids, and tissue respiratory factor. Such a
composition meets all the limitations of claim 43, which is therefore unpatentable
under 35 U.S.C. § 103.
Appeal No. 2001-1177 Page 13
Application No. 08/781,868

C. The other combinations
The examiner rejected claims 36 and 39-42 as obvious over N’Guyen and
Burke, further combined with Cavazza (claim 36), Piazza (claim 39), Finkenauer
(claim 40), Spector (claim 41), or Otsu (claim 42). These references disclose
each of the additional ingredients recited in the rejected dependent claims.
However, we reverse these rejections because the references do not provide
adequate motivation to combine their respective compositions.
Cavazza discloses compositions comprising acetyl-L-carnitine (see
column 1, lines 8-11 and 28-29) for treating dermatoses such as icthyosis and
psoriasis (column 6, line 66 to column 7, line 3). Piazza discloses compositions
comprising epidermal growth factor (column 12, lines 28-32) for treating
hyperproliferative conditions such as cancer or psoriasis (column 2, lines 23-39).
Finkenauer teaches compositions comprising fibroblast growth factor (column 1,
lines 23-28) for treating wounds (column 1, lines 64-66). Spector teaches
compositions comprising glutathione peroxidase activity for treating cataracts
(column 4, lines 37-44). Otsu teaches compositions comprising cysteine (column
4, line 34) for treating skin diseases and screening UV rays (column 3, lines 1-6.
None of these references is addressed to the problem of skin aging that is
the focus of N’Guyen and Burke. The examiner has not adequately explained
why a person of skill in the art would have combined an ingredient disclosed to
be useful for, e.g., treating psoriasis with other ingredients disclosed to be useful
in treating skin aging.
Appeal No. 2001-1177 Page 14
Application No. 08/781,868

The examiner argues that all of the references teach that the various
agents are useful in treating damaged skin, and therefore it would have been
obvious to combine them. In our view, this characterization overstates the
breadth of the disclosures of Cavazza, Piazza, Finkenauer, Spector, and Otsu.
These references disclose certain agents to be useful in treating skin that is
suffering from a specific condition, not as useful in treating “damaged” skin
generally, regardless of the source of the damage. Importantly, none of these
references discloses the various agents to be useful in treating age-damaged
skin, and therefore they would not have provided the requisite motivation to
combine their respective agents with the glutathione and selenoamino acids
taught by N’Guyen and Burke.
The rejection of claims 36 and 39-42 under 35 U.S.C. § 103 is reversed.
D. The method claims
The examiner rejected all of the method claims (claims 45-54) as obvious
over the combined disclosures of N’Guyen, Burke, Levin, Cavazza, Piazza,
Finkenauer, Spector, and Otsu. The examiner reviewed the disclosures of each
of the cited references and concluded that
[e]ach of these references discloses methods of treating free
radical damaged skin by applying compositions comprising one or
more of the recited ingredients. These methods provide for the
treatment of damaged skin, and/or the prevention of further
damage to the skin. It would have been obvious to one of ordinary
skill in the art to have used compositions comprising glutathione
and selenoamino acids, as well as [the other recited agents] for the
repair of free radical damaged skin, as these ingredients have been
shown to be important and/or effective for the healing of free radical
damaged skin, and other types of injuries or damage. Combination
of these ingredients for use in the method of treatment would be
Appeal No. 2001-1177 Page 15
Application No. 08/781,868

expected to increase the healing properties of the composition,
therefore, the invention as a whole is prima facie obvious. . . .

Examiner’s Answer, page 18.
We reverse this rejection. The examiner characterizes the rejected claims
as directed to a “method of repairing free radical damage.” However, the claims
do not encompass a method of repairing any free radical damage, but are limited
to a “method for enhancing repair from free radical damage to skin as a result of
treatment of the skin with exfoliants, chemosurgery or laser therapy.” This
preamble language constitutes a limitation of the claimed method, because it
excludes from the scope of the claimed method treatment of patients other than
those who have suffered free radical damage to their skin as a result of
exfoliants, chemosurgery, or laser therapy. Thus, although the preamble did not
further limit the composition claims, it does limit the method claims. The
examiner has pointed to nothing in the relied-on references that suggests that
any of the disclosed agents are useful in treating skin damaged by exfoliants,
chemosurgery or laser therapy. Thus, the examiner has not shown that the
methods of claims 45-54 would have been prima facie obvious in view of the
prior art.
Summary
The composition of claim 35 is anticipated by both the claims and
disclosure of Hersh. The composition is also rendered obvious by the
disclosures of N’Guyen and Burke. We, therefore, affirm the rejections of claim
35 for obviousness-type double patenting, anticipation, and obviousness. Claims
Appeal No. 2001-1177 Page 16
Application No. 08/781,868

36-44 fall with claim 35. However, none of the cited references teaches or
suggests a method of using a composition comprising glutathione and
selenoamino acids for treating skin damaged by exfoliants, chemosurgery, or
laser therapy, as required by claims 45-54. We therefore reverse the rejections
of these claims.
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

Donald E. Adams )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Demetra J. Mills )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Eric Grimes )
Administrative Patent Judge )
Appeal No. 2001-1177 Page 17
Application No. 08/781,868

MALCOLM B. WITTENBERG
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