Ex Parte Doring et al

Patent Trial and Appeal Board

Sep 19, 2013

11087395 (P.T.A.B. Sep. 19, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte THOMAS DORING, MARTIN SUGAR, RAINER WOLBER,
VOLKER WENDEL, THOMAS BLATT, CLAUDIA MUNDT,
JENS SCHULZ, JAN BATZER, and RIXA DIPPE1
__________

Appeal 2011-010412
Application 11/087,395
Technology Center 1600
__________

Before TONI R. SCHEINER, JACQUELINE WRIGHT BONILLA, and
JOHN G. NEW, Administrative Patent Judges.

BONILLA, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
cosmetic preparation comprising a UV filter substance. The Examiner
rejected the claims as lacking sufficient written description support,
anticipated, obvious, and on the ground of nonstatutory obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b).

1 Appellants identify the Real Party in Interest as Beiersdorf AG (App. Br.
3).
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For the reasons discussed below, we reverse the written description
and obviousness rejections, and affirm the anticipation and obviousness-type
double patenting rejections.
STATEMENT OF THE CASE
The Specification describes “cosmetic and dermatological
preparations with a high UVA balance” (Spec. 1). The Specification
discusses the use of UVB and UVA filters to protect against UV radiation
damage from the sun (id. at 1-3). The Specification defines “UVA balance”
as follows:

(id. at 6). The Specification states that the “PPD value is usually determined
in vitro,” but “[a]lternatively, the PPD value can also be determined in vivo”
(id. at 6-7). The Specification further states that the “value of the SPF (Sun
Protection Factor, also called LPF for Light Protection Factor) is determined
in vivo in accordance with COLIPA”2 (id. at 7).
Claims 44-50, 52-61, 63, 65-67, and 69-74 are on appeal.3 Claim 44,
the only independent claim, reads as follows:
44. A cosmetic preparation, wherein the preparation comprises at
least one UV filter substance and exhibits a UVA balance of higher
than 15.

2 COLIPA, now Cosmetics Europe, is a European cosmetic industry trade
association. See https://www.cosmeticseurope.eu/about-cosmetics-
europe.html (last visited September 18, 2013).
3 Claims 1-43 are cancelled, and claims 51, 62, 64 and 68 are withdrawn
(App. Br. 3).
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Certain dependent claims recite specific UVA balance values, SPF values,
and types of UV filters. Other dependent claims recite specific non-UV
filter compounds, such as glycerol, included in the preparation.
The claims stand rejected as follows:
I. Claims 44-50, 52-61, 63, 65-67, and 69-74 under 35 U.S.C. § 112,
first ¶, as failing to comply with the written description requirement;4
II. Claims 44-50, 52-54, 63, 65, and 69 under 35 U.S.C. § 102(b) as
anticipated by Wendel;5
III. Claims 44-46, 52-54, and 69-70 under 35 U.S.C. § 102(b) as
anticipated by Ferrero6 as evidenced by Wendel;
IV. Claims 55-57, 66-67, and 70-73 under 35 U.S.C. § 103(a) as obvious
over Wendel in view of Malpede;7
V. Claims 58-61, 72, and 74 under 35 U.S.C. § 103(a) as obvious over
Wendel in view of Malpede, and in further view of Yu;8 and
VI. Claims 44-50, 52-61, 63, 65-67, and 69-74 on the ground of
nonstatutory obviousness-type double patenting as unpatentable over

4 See Ans. 4-6.
5 Wendel et al., The influence of pre-irradiation on the predictability of in
vivo UVA protection with a new in vitro method, 19 PHOTODERMATOL
PHOTOIMMUNOL. PHOTOMED. 93-97 (2003); see Ans. 6-8.
6 Ferrero et al., Sunscreen in vitro spectroscopy: application to UVA
protection assessment and correlation with in vivo persistent pigment
darkening, 24 INTERNATIONAL JOURNAL OF COSMETIC SCIENCE 63-70
(2002); see Ans. 8-10.
7 Malpede et al., 6,514,485 B1, issued Feb. 4, 2003; see Ans. 10-12
8 Yu et al., 5,091,171, issued Feb. 25, 1992; see Ans. 12-15.
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claims 1-21 of U.S. Pat. No. 7,341,712, claims 1-35 of U.S. Pat. No.
7,029,660, and claims 1-35 of U.S. Pat. No. 7,060,257.9
I. Written Description
The Examiner states the “instant specification provides no structure
function relationship between sunscreen agents, amount and the
corresponding UVA balance,” and “does not disclose an example that would
meet the limitations of the claimed UVA balance or SPF/UVA balance
combination” (Ans. 6). On this basis, the Examiner finds that the
Specification provides insufficient written description to support the claims
(id. at 4, 6).
When evaluating claims for written description, a Specification must
be viewed from the perspective of a person of skill in the art, who is deemed
to “come[] to the [application] with the knowledge of what has come
before.” LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345
(Fed. Cir. 2005). Thus, a Specification need not spell out every detail of the
invention, but “enough must be included to convince a person of skill in the
art that the inventor possessed the invention” at the time the application was
filed. Id. “[T]he written description requirement does not demand either
examples or an actual reduction to practice; a constructive reduction to
practice that in a definite way identifies the claimed invention can satisfy the
written description requirement.” Ariad Pharmaceuticals, Inc. v. Eli Lilly
and Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010); Streck, Inc. v. Research &
Diagnostic Systems, Inc., 665 F.3d 1269, 1285 (Fed. Cir. 2012).

9 Göppel et al., 7,341,712 B2, issued Mar. 11, 2008; Göppel et al.,
7,029,660 B2, issued Apr. 18, 2006; Göppel et al., 7,060,257 B2, issued Jun.
13, 2006; see Ans. 15-18.
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The appealed claims recite a cosmetic preparation comprising a UV
filter substance, where the preparation exhibits a specific UVA balance. The
Examiner does not dispute that many UV filter substances were known in
the art at the time of filing. Rather, the Examiner focuses on the “UVA
balance” element of the claims. We find that the Specification sufficiently
indicates that Appellants possessed at least a constructive reduction to
practice of the claimed preparation. One would have understood from the
Specification that Appellants possessed the ability to combine different
known UVB and UVA filter substances, based on their known or derived in
vitro PPD and in vivo SPF factors, into a cosmetic preparation (Spec. 12-15;
see also 16-43), and modify those substances in amount or kind as needed to
achieve the recited UVA balance, which Appellants knew to measure as
described in the Specification (Spec. 6-7). See Ex parte Parks, 30 USPQ2d
1234, 1236 (BPAI 1993) (stating “it is sufficient if the originally-filed
disclosure would have conveyed to one having ordinary skill in the art that
an appellant had possession of the concept of what is claimed”). Thus, the
Specification provides sufficient information to convey that Appellants
possessed the invention claimed. We reverse the Examiner’s written
description rejection of claims 44-50, 52-61, 63, 65-67, and 69-74.
II. Anticipation by Wendel
As noted by Appellants, the Examiner’s anticipation rejection based
on Wendel “essentially alleges that [the reference] inherently discloses
cosmetic preparations which contain UV filter substances as recited in, e.g.,
claims 48-50, 63 and 65[,] and have a UVA balance and a sun protection
factor as recited in claims 44-47 and claim[s] 52-54” (App. Br. 13; Ans. 6-
8). The Examiner looks to information presented in Tables 1-3 of Wendel,
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which describe components of twelve different sunscreen products
(designated A1-A6 and B1-B6), as well as “labeled SPF” and in vivo and in
vitro PPD for each product (Wendel, 94-95; Ans. 7). The Examiner uses
that information to calculate UVA balance as described in the Specification
(Spec. 6; Ans. 6-7). The Examiner summarizes the information and
calculations in the following table:

(Ans. 7.) Based on the above, the Examiner states that she “has a reasonable
basis to believe that the properties claimed in the present invention are
inherent in the composition disclosed by Wendel,” and therefore the “burden
of proof is shifted to the Appellant to prove that the properties are not
inherent” in sunscreen products described in Wendel (id. at 8).
Appellants argue that calculating the recited UVA balance of a
preparation requires determining the SPF value according to “the COLIPA
method,” citing page 7 of the Specification and claims 52-54 (App. Br. 14).
Appellants argue that one cannot tell from Wendel what method, i.e., in vivo
or in vitro, COLIPA method or otherwise, was used to determine the
“labeled SPF” values disclosed in Wendel. Thus, according to Appellants,
“because WENDEL fails to disclose the tested products with sufficient
specificity, is it impossible to tell whether the UVA balance values which
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the Examiner has calculated” were determined according to the described
method in the Specification (id. at 15). Appellants further argue that:
[T]he Examiner has the burden of establishing that (all of) the
labeled SPF values set forth by WENDEL were necessarily
measured according to the COLIPA method. Accordingly, the
question here is not “what proof does Applicant have that
Wendel does not use the COLIPA method?” (see bottom of
page 10 of the May 14, 2010 Final Office Action) but “what
proof (i.e., not just ‘reasonable expectation’) does the Examiner
have that the authors of WENDEL did use the COLIPA
method?”.
(Id. at 16 (emphasis in original).) In other words, Appellants contend that
the question to ask when assessing anticipation by inherency is whether the
Examiner establishes that Wendel used the COLIPA method to determine
the disclosed SPF values presented in Table 2 of Wendel.
This is not the correct inquiry, however. An Examiner has the burden
of providing reasonable proof that a claim limitation is an inherent
characteristic of the prior art. In re Best, 562 F.2d 1252, 1254-55 (CCPA
1977); see also Crown Operations Int’l, Ltd. v. Solutia Inc., 289 F.3d 1367,
1377 (Fed. Cir. 2002). The proper question in this case, therefore, is
whether the Examiner provides “reasonable proof” that the recited UVA
balance is an inherent characteristic of at least one of the sunscreen
formulations disclosed in Wendel.
The Examiner meets the relevant “burden of production by
‘adequately explain[ing] the shortcomings it perceives so that the applicant
is properly notified and able to respond.’” In re Jung, 637 F.3d 1356, 1362
(Fed. Cir. 2011) (quoting Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir.
2007)). If met, the burden of proof then shifts to Appellants “to prove that
the subject matter shown to be in the prior art does not possess the
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characteristic relied on.” Best, 562 F.2d at 1254-55; In re Schreiber, 128
F.3d 1473, 1478 (Fed. Cir. 1997) (holding that once the Examiner
established a prima facie case of anticipation, the burden of proof was
properly shifted to the inventor to rebut the finding of inherency).
Here, the Examiner meets the required burden of production to shift
the burden of proof to Appellants. According to the Examiner’s
calculations, Wendel’s sunscreens B1 and B3, for example, exhibit a UVA
balance of around 38 and 48, respectively. The Examiner had a reasonable
basis for believing that one had determined the “labeled SPF” described in
Wendel either by the COLIPA method itself, which was known in the art
(Ans. 20-21; Spec. 6), or by a different method that determined a SPF value
that did not significantly deviate from a SPF value as determined by the
COLIPA method. In other words, the Examiner had reason to believe that
the “labeled SPF” corresponded closely to a SPF as measured by any
established method, including the COLIPA method (see May 14, 2010
Office Action, p. 11). As such, disclosures in Wendel and the Examiner’s
calculations provided sufficient reasonable proof that at least some of
Wendel’s sunscreens, such as B1 and B3, inherently exhibited the UVA
balance and SPF recited in claims 44-50, 52-54, 63, 65, and 69.
Thus, the burden shifted to Appellants to prove that Wendel’s
sunscreens did not inherently exhibit the recited UVA balance, or SPF in
relation to claims reciting a specific SPF. On the record before us,
Appellants provide inadequate proof in this regard. See App. Br. 13-20
(arguing that the Examiner fails to meet an initial burden of production
because she does not prove that Wendel used the COLIPA method to
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determine SPF). We affirm the Examiner’s rejection of claims 44-50, 52-54,
63, 65, and 69 as anticipated by Wendel.
III. Anticipation by Ferrero as evidenced by Wendel
In relation to sunscreen products and related PPD and SPF
information described in Ferrero, the Examiner similarly calculates UVA
balance values (Ans. 8-9; see also Ferrero, 65, Table III). The Examiner
acknowledges that Ferrero describes PPD as measured in vivo (id. at 9),
while the Specification discloses that UVA balance takes into account PPD
as measured in vitro. The Examiner also states, however, “as can be seen in
Wendel, the in vitro and in vivo PPD are within standard error to one
another” (id.). Along these lines, Figure 1 in Wendel presents a graph
indicating a linear, and a fairly close 1:1, correlation between in vivo PPD
values and in vitro PPD values, with reasonable reproducibility. (See
Wendel, 95, Fig. 1 and “R2 = 0.898”.) Consistently, the instant Specification
describes that when determining UVA balance, the “PPD value is usually
determined in vitro,” but “[a]lternatively, the PPD value can also be
determined in vivo” (Spec. 6-7).
Thus, in citing Wendel, the Examiner presents reasonable proof that
“the PPD of Ferrero would be expected to be closely related to what the
value is in vitro” (Ans. 9). Likewise, for the same reasons discussed above
regarding Wendel, the Examiner had reason to believe that the “in vivo SPF”
described in Ferrero (at 65, Table III) corresponded closely to a SPF as
measured by any established method, including the COLIPA method. Once
again, therefore, the Examiner’s calculations provided sufficient reasonable
proof that at least some of Ferrero’s sunscreens, such as sunscreens A-D,
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inherently exhibited the recited UVA balance and SPF in the claims (Ans.
8).
Thus, the burden shifted to Appellants to prove that Ferrero’s
sunscreens did not inherently exhibit the recited UVA balance or SPF. On
the record before us, Appellants provide inadequate proof in this regard. See
App. Br. 20-22. We affirm the Examiner’s rejection of claims 44-46, 52-54
and 69-70 as anticipated by Ferrero as evidenced by Wendel.
IV. Obviousness over Wendel in view of Malpede
The Examiner rejects dependent claims 55-57, 66-67, and 70-73 over
Wendel in view of Malpede (Ans. 10-12, 23).
Claims 55-57 and 72
Claims 55-57 and 72 recite the preparation of claim 44 further
comprising certain non-UV filter compounds, such as glycerol or
dihydroxyacetone. Malpede describes including glycerol (also called
glycerin) as a conventional wetting agent “in amounts from about 0.1 to
about 30%,” as well as “artificial tanning agents such as dihydroxyacetone
(DHA) and its derivatives,” in sunscreen compositions (Malpede, col. 8, l.
61 – col. 9, l. 1; col. 9, ll. 27-33). The Examiner states that “[o]ne of
ordinary skill in the art would have been motivated to utilize glycerin as
Malpede et al. teach it is a conventional component in these types of
formulations” (Ans. 11).
While we do not disagree with this assessment by the Examiner, that
is not the end of the inquiry. The Examiner recognizes that neither Wendel
or Malpede expressly describe the concept of UVA balance or how to
determine UVA balance as disclosed in the instant Specification. Once
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again, the Examiner relies on inherency in relation to the UVA balance
element.
As noted by Appellants, the Examiner does not dispute “that the in
vitro PPD value and the in vivo SPF value depend strongly on the
composition of the preparation such as, e.g., type and concentration of the
UV filter substance(s), type and concentration of remaining components of
the sunscreen preparation, type of formulation, etc.” (App. Br. 18, citing
May 14, 2010 Final Office Action, p. 12) (emphasis added.) In other words,
adding non-UV filter compounds, such as glycerol or dihydroxyacetone, to
Wendel’s compositions might impact in vitro PPD and in vivo SPF values,
and consequently the UVA balance, of overall preparations.
The Examiner does not sufficiently establish that one reading Wendel
in view of Malpede would have had reason to include glycerol or
dihydroxyacetone (or other recited non-UV filter ingredients) in an amounts,
relative to UV filter kinds and amounts, that maintain the high UVA balance
inherently exhibited by the specific sunscreens described in Wendel—a
feature not expressly described in the cited references. The Examiner does
not provide reasonable proof that the sunscreens of Wendel, assuming they
also included specific non-UV filter ingredients, such as glycerol, would
have necessarily exhibited the recited UVA balance. Thus, the Examiner
does not establish by a preponderance of the evidence that Wendel in view
of Malpede expressly or inherently taught or suggested a sunscreen
preparation comprising the recited non-UV filter ingredients, where the
preparation also exhibited the recited UVA balance. We reverse the
rejection of claims 55-57 and 72 over Wendel in view of Malpede.
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Claims 66, 67, and 71
Claims 66 and 71 recite the preparation of claim 44 comprising “at
least 0.5 % by weight, based on a total weight of the preparation, of at least
one organic broadband filter.” Claim 67, which depends on claim 66, recites
that the organic broadband filter “is selected from asymmetrically
substituted s-triazine compounds and benzotriazoles.” In relation to these
claims, the Examiner acknowledges that Wendel “does not specify the
amount of the UV filter ingredients” used in the disclosed sunscreens (Ans.
10). The Examiner states, however, that: (1) claim 4 in Malpede “indicates
that the amount of UV filter agents suitable for incorporation into
compositions if from about 0.05 to 30% of the total weight of the
composition”; (2) Example E in Malpede discloses formulations comprising
5% of various sunscreen agents; and (3) Malpede describes substituted
triazoles as sunscreens (id. at 10-11). The Examiner states that it “would
have been obvious to one of ordinary skill in the art to combine the
teachings of Wendel et al. and Malpede et al. and utilize the UV filters in an
amount from 0.05 to 30%,” and routinely optimized the amount of sunscreen
“in order to best achieve the desired SPF” (id. at 11-12).
Again, the Examiner relies on inherency in relation to the UVA
balance element recited in claim 44. As noted by Appellants, the Examiner
does not dispute “that the in vitro PPD value and the in vivo SPF value
depend strongly on the composition of the preparation such as, e.g., type and
concentration of the UV filter substance(s), type and concentration of
remaining components of the sunscreen preparation, type of formulation,
etc.” (App. Br. 18) (emphasis added.) In other words, altering the type
and/or amounts of UV filter compounds in Wendel’s compositions might
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impact in vitro PPD and in vivo SPF values, and consequently the UVA
balance, of the overall preparations. While we believe it is likely that the
sunscreen products described in Wendel comprised at least 0.5% of at least
one UV filter, Wendel itself does not indicate the amounts of any individual
component. As such, the Examiner does not provide reasonable proof that
the sunscreens of Wendel would have necessarily exhibited the recited UVA
balance if the sunscreens comprised at least 0.5% by total weight of at least
one organic broadband filter.
Thus, the Examiner does not establish by a preponderance of the
evidence that Wendel in view of Malpede expressly or inherently taught or
suggested a sunscreen preparation comprising at least 0.5% by total weight
of at least one organic broadband filter, where the preparation also exhibited
the recited UVA balance. We reverse the Examiner’s rejection of 66, 67,
and 71 over Wendel in view of Malpede.
Claim 70
Claim 70 recites the preparation of claim 44 exhibiting “a UVA
balance of higher than 22 and a sun protection factor, determined in
accordance with COLIPA method, of at least 20.” As stated above, we
affirm the Examiner’s rejection of claim 70, among other claims, as
anticipated by Ferrero as evidenced by Wendel. Ferrero discloses
sunscreens B-D having a SPF of at least 20 and a UVA balance higher than
22, as calculated by the Examiner. For the reasons discussed above, such
disclosures and calculations suffice to shift the burden to Appellants to show
that the inherent features (recited SPF and UVA balance) are not present—a
burden Appellants does not adequately meet.
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In relation to Wendel, however, Examiner does not point to
sunscreens, or calculations in relation to such sunscreens, that exhibit both a
UVA balance higher than 22 and a SPF of at least 20 (Ans. 7). In addition,
for the reasons discussed above, the Examiner does not adequately explain
how Malpede overcomes Wendel’s deficiency in relation to the UVA
balance element. We reverse the rejection of claim 70 as obvious over
Wendel in view of Malpede.
V. Obviousness over Wendel in view of Malpede and Yu
The Examiner rejects claims 58-61, 72, and 74 over Wendel in view
of Malpede and Yu (Ans. 12-15). These claims recite the preparation of
claim 44 further comprising certain non-UV filter compounds, i.e., creatine,
creatinine, or taurine, which the Specification describes as “substances
which start or enlarge cellular energy depots” (Spec. 15).
For the same reasons discussed above regarding the obviousness
rejection of claims 55-57 and 72, the Examiner does not provide reasonable
proof that the sunscreens of Wendel, assuming they also included creatine,
creatinine, or taurine, would have necessarily exhibited the recited UVA
balance. The Examiner only points out that Yu lists such ingredients as
suitable to include in sunscreens and it would have been obvious to combine
the teachings of Wendel, Malpede, and Yu (Ans. 13-14). Thus, the
Examiner does not establish by a preponderance of the evidence that Wendel
in view of Malpede and Yu expressly or inherently taught or suggested a
sunscreen preparation comprising the recited non-UV filter ingredients,
where the preparation also exhibited the recited UVA balance. We reverse
the Examiner’s rejection of claims 58-61, 72, and 74 over these references.
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VI. Obviousness-type double patenting
The Examiner rejects all claims under appeal on the ground of
nonstatutory obviousness-type double patenting as unpatentable over claims
in three different issued patents. Appellants do not address these rejections,
but state they will “decide whether the submission of one or more terminal
disclaimers is appropriate once allowable subject matter has been indicated”
(App. Br. 5-6). In the absence of a response by Appellants on appeal, we
summarily affirm these rejections.
SUMMARY
We reverse the Examiner’s rejection of claims 44-50, 52-61, 63, 65-
67, and 69-74 as failing to comply with the written description requirement.
We affirm the rejections of claims 44-50, 52-54, 63, 65, and 69 as
anticipated by Wendel, as well as claims 44-46, 52-54, and 69-70 as
anticipated by Ferrero as evidenced by Wendel. We reverse the rejections of
claims 55-57, 66-67, and 70-73 as obvious over Wendel in view of Malpede,
as well as claims 58-61, 72, and 74 as obvious over Wendel in view of
Malpede and Yu. We summarily affirm the rejections of claims 44-50, 52-
61, 63, 65-67, and 69-74 on the ground of nonstatutory obviousness-type
double patenting as unpatentable over claims in U.S. Pat. No. 7,341,712,
U.S. Pat. No. 7,029,660, and U.S. Pat. No. 7,060,257.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED
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