Ex Parte Bernstein

Patent Trial and Appeal Board

Nov 20, 2014

12854788 (P.T.A.B. Nov. 20, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte JOEL E. BERNSTEIN1
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Appeal 2013-008219
Application 12/854,788
Technology Center 1600
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Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and
ERICA A. FRANKLIN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating psoriasis, which have been rejected as either anticipated or
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 According to Appellant, the Real Party in Interest is Elorac, Inc. (Appeal
Br. 2).
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STATEMENT OF THE CASE
“Psoriasis . . . has been the object of a variety of oral and topical
treatments. Included among these treatments is topically applied anthralin.”
(Spec. 1, ¶ 1.) The Specification states that “[p]rior attempts to prepare
stable formulations of anthralin-containing shampoos have been heretofore
unsuccessful primarily due to the surfactants in a shampoo rapidly degrading
the anthralin” (id. at 1, ¶ 3). The Specification describes “anthralin
formulations . . . with anthralin particles encapsulated within a crystalline
coating of glyceryl monolaurate and glyceryl monomyristate and with blue
dyes incorporated into the compositions” (id. at 1–2, ¶ 4). The Specification
states that “[a]nthralin incorporated into monoglyceride capsules is useful to
formulate stable shampoos. The monoglyceride coating protects anthralin
from degradation by the shampoo surfactants.” (Id. at 4, ¶ 23.)
Claims 16–18 are on appeal. Claim 16 is illustrative and reads as
follows:
16. A method for treating psoriasis of the scalp, the method comprising:
(a) lathering the scalp and hair with a shampoo composition
comprising anthralin encapsulated by one or more monoglycerides and
dispersed in water in oil, or oil in water emulsions, and containing a blue
dye;
(b) contacting the shampoo composition to the scalp from about 1 to
10 minutes; and
(c) rinsing the scalp thoroughly with water.

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DISCUSSION
Issue
The Examiner has rejected claims 16–18 under 35 U.S.C. § 102(b) as
anticipated by, or alternatively under 35 U.S.C. § 103(a) as obvious based
on, Drugs.com2 (Ans. 4).3 The Examiner finds that Drugs.com discloses
“using a composition made of 1.2% microcrystalline encapsulated . . .
anthralin in a aqueous cream base (an oil and water emulsion) containing
glyceryl monolaurate (a glyceride or oil), glyceryl monomyristate (a
glyceride or oil), citric acid, FD&C dye #1 (a blue dye), and water” (id.).
The Examiner finds that “the composition is taught to be rubbed into damp
hair (lathering) the part (a), which as stated before can be from 5-15 minutes
(reading on the second part (b), the scalp is then rinsed” (id.).
Appellant contends that the prior art composition is a cream rather
than a shampoo (Appeal Br. 4). Appellant contends that Drugs.com relates
to “creams which by definition have a different formulation and do not
lather” (id. at 5). Appellant also argues that “the steps for application of the
creams in the 2 ads are not identical to the steps in the claimed methods”
because “the application step of the cream versus the claimed shampoo is
different in timing and type of contact with the scalp” (id. at 6).

2 Drugs.com, “Zithranol-RR Cream Dosage” (July 2008).
3 The Examiner also cites, as an alternative basis for the rejection, a
Zithranol-RR package insert dated April 2009. The cited posting from
Drugs.com, however, is also a package insert, and includes the same relevant
disclosure as the April 2009 insert. We therefore limit our discussion to the
Drugs.com publication.
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The issue presented is whether claim 16 encompasses a method that is
described in, or would have been obvious based on, Drugs.com.
Findings of Fact
1. Drugs.com discloses that “Zithranol-RR contains 1.2%
microcrystalline encapsulated anthralin in a green aqueous cream base
containing glyceryl monolaurate, glyceryl monomyristate, citric acid,
sodium hydroxide, FD&C Blue No. 1 and purified water. The anthralin in
Zithranol-RR is microencapsulated.” (Drugs.com 1.)
2. Drugs.com discloses “commenc[ing] treatment using a short
contact time (5–15 minutes)” (id. at 3).
3. Drugs.com describes administering Zithranol-RR as follows:
For the scalp: Wash the hair with shampoo, rinse with water
and apply Zithranol-RR cream while the hair is still damp. Rub
the cream well into the psoriatic lesions. . . . At the end of each
period of contact, rinse hair and scalp thoroughly with cool to
lukewarm water and then shampoo the hair and scalp to remove
any surplus cream.
(Id.)
Principles of Law
“[D]uring examination proceedings, claims are given their broadest
reasonable interpretation consistent with the specification.” In re Hyatt, 211
F.3d 1367, 1372 (Fed. Cir. 2000).
“[W]hile it is true that claims are to be interpreted in light of the
specification and with a view to ascertaining the invention, it does not follow
that limitations from the specification may be read into the claims.” Sjolund
v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988)
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“[D]uring patent prosecution when claims can be amended,
ambiguities should be recognized, scope and breadth of language explored,
and clarification imposed.” In re Zletz, 893 F.2d 319, 321 (Fed. Cir. 1989).
Analysis
Drugs.com discloses a composition comprising all of the components
required by part (a) of claim 16 (FF1); it discloses rubbing that composition
into damp hair to treat psoriasis (FF3); it discloses a range of contact times
that overlaps the range recited in part (b) of claim 16 (FF2); and it discloses
rinsing the scalp thoroughly with water (FF3). We conclude that Drugs.com
discloses a method that meets, or at a minimum would have made obvious,
all of the limitations of claim 16.
Appellant argues that the composition described in Drugs.com is not a
shampoo but a cream (Appeal Br. 4) and that “creams . . . by definition have a
different formulation and do not lather” (id. at 5). Appellant argues that a
“shampoo has a composition suitable to cleanse hair” (id.) and points to the
Specification’s Example 3 as showing that “monoglyceride-encapsulation
protects the anthralin from degradation by surfactants in a shampoo” (id. at 4).
Appellant, however, has not identified any component that is required,
but not recited in claim 16, in order for a composition to be a “shampoo
composition.” The Specification exemplifies a shampoo formulation made
by combining anthralin, glyceryl monolaurate, and glyceryl monomyristate
with a “buffer solution containing the surfactants sucrose stearate and
glycerth-2 cocoate along with FD&C Blue #1” (Spec. 5, ¶ 28) and states that
“[t]he monoglyceride coating protects anthralin from degradation by the
shampoo surfactants” (id. at 4, ¶ 23).
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However, the Specification also makes clear that a “shampoo
composition” does not require a surfactant, stating that “[w]hen the
composition is a shampoo, surfactants may be incorporated into the
shampoo” (id. at 2, ¶ 13 (emphasis added)). This description suggests that
shampoos do not necessarily include surfactants.
Appellant has not provided evidence to support interpreting a
“shampoo composition” to require any ingredients in addition to those
recited in claim 16.4 Appellant has also not provided evidence to support
interpreting a “shampoo composition” to exclude any of the ingredients that
are included in the prior art composition. We therefore agree with the
Examiner (Ans. 5) that the broadest reasonable interpretation of a “shampoo
composition,” in light of the Specification, encompasses the Zithranol-RR
composition disclosed by Drugs.com.
Appellant also argues that the step of “lathering” distinguishes the
claimed method from that of Drugs.com, in that creams do not lather
(Appeal Br. 5). Appellant states that he “has checked dictionary definitions
of ‘lather’ and of ‘cream’ and finds no cross links of these terms suggesting
they are synonymous” (id.). Appellant included copies of the relevant

4 Appellant has submitted advertisements for Zithranol Shampoo and
evidence describing Macare® G-2C. However, those pieces of evidence
were submitted for the first time with either the Appeal Brief (Exhibit C) or
the Reply Brief (Exhibits D and E). Because evidence submitted after filing
an Appeal Brief can only be admitted if prosecution is re-opened, 37 C.F.R.
§ 41.33(d)(2), we have not considered the evidence relating to Zithranol
Shampoo or Macare® G-2C.
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definitions with the Appeal Brief (Evidence App’x, Exhibits D and E).5 In
response, the Examiner provided the entry for “lather” from thesaurus.com,
and points out that “cream” is a synonym for the noun “lather” (Ans. 7).6
We conclude that, whatever the ordinary meaning of “lather” is, it is
reasonable based on the evidence of record to conclude that the prior art
composition can be used in the same manner as the “shampoo composition”
recited in claim 16. As discussed above, the composition disclosed by
Drugs.com includes all of the components of the “shampoo composition”
recited in claim 16 and Appellant has not provided evidence that a “shampoo
composition” requires anything more or less than what is in the composition
of Drugs.com. It is therefore reasonable to conclude that, if the composition
recited in claim 16 is capable of “lathering the scalp and hair” (claim 16),
then so is the prior art Zithranol-RR composition. See In re Best, 562 F.2d
1252, 1254-55 (CCPA 1977) (“[‘W]here the Patent Office has reason to
believe that a functional limitation asserted to be critical for establishing
novelty in the claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to require the
applicant to prove that the subject matter shown to be in the prior art does
not possess the characteristic relied on.’”). See also id. at 1255:

5 The dictionary definitions were submitted for the first time with the Appeal
Brief but are not excluded from consideration by 37 C.F.R. § 41.33(d)
because dictionaries are not considered evidence. See 37 C.F.R. § 41.30
(“[F]or the purposes of this subpart Evidence does not include dictionaries,
which may be cited before the Board.”). We have considered the dictionary
definitions submitted with the Appeal Brief.
6 For the reasons discussed in footnote 5, we have also considered the
Examiner’s thesaurus.com definitions of lather.
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Where . . . the claimed and prior art products are identical or
substantially identical . . . the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently
possess the characteristics of his claimed product. Whether the
rejection is based on ‘inherency’ under 35 U.S.C. § 102, on
‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or
alternatively, the burden of proof is the same, and its fairness is
evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products.
While the claims here are directed to a method rather than a product,
the issue in dispute is whether the composition recited in claim 16 is capable
of “lathering” while the prior art composition is not. Thus, the disputed
issue concerns the properties of the respective compositions, not their
respective methods of use: both compositions are applied to wet hair, and
the only disputed issue is how they behave when so applied. Appellant has
provided no basis for concluding that the composition recited in claim 16
would behave any differently when applied to wet hair than would the
Zithranol-RR composition disclosed by Drugs.com.
Finally, Appellant argues that “the steps for application of the creams
in the 2 ads are not identical to the steps in the claimed methods” (Appeal
Br. 6). Appellant argues that “the application step of the cream versus the
claimed shampoo is different in timing and type of contact with the scalp”
(id.).
This argument is also unpersuasive. Claim 16 recites three steps: (a)
lathering, (b) contacting with the scalp, and (c) rinsing. As discussed above,
Appellant has not shown that the “lathering” step differs from the step of
rubbing into damp hair that is described by Drugs.com (FF3). That
publication also describes contact times of 5–15 minutes (FF2) and rinsing
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thoroughly with water (FF3). At a minimum, the disclosure of Drugs.com
would have made obvious a contact time in the range of 5–10 minutes,
which is within the 1–10 minute range recited in claim 16. Appellant has
not provided evidence that the “type of contact with the scalp” (Appeal Br.
6) achieved with Zithranol-RR differs in any way from what is required by
claim 16.
Conclusion of Law
Claim 16 encompasses a method that is described in, or would have
been obvious based on, Drugs.com. Claims 17 and 18 have not been argued
separately and therefore fall with claim 16. 37 C.F.R. § 41.37(c)(1)(iv).
SUMMARY
We affirm the rejection of claims 16–18 under 35 U.S.C. § 102(b) as
anticipated by, or alternatively under 35 U.S.C. § 103(a) as obvious based
on, Drugs.com.
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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