Ex Parte Bernstein

Patent Trial and Appeal Board

Nov 21, 2013

12036901 (P.T.A.B. Nov. 21, 2013)

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. BERNSTEIN
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Appeal 2013-006114
Application 12/036,901
Technology Center 1600
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Before ERIC GRIMES, MELANIE L. McCOLLUM, and
ERICA A. FRANKLIN, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
method of treating inflammatory acne vulgaris. The Patent Examiner
rejected the claims as anticipated. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm.

1 Appellants identify the Real Party in Interest as Elorac, Ltd. (See App. Br.
1.)
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Application 12/036,901

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STATEMENT OF THE CASE
Claims 1-3 are on appeal. Claim 1 is representative and reads as
follows:
1. A method of treating inflammatory acne vulgaris in patients having
inflammatory acne vulgaris lesions the method consisting [of] administering
a therapeutically effective amount of carbamide peroxide in a vehicle
suitable for topical application to the skin of a patient with such lesions.

The Examiner rejected claims 1-3 under 35 U.S.C. § 102(b) as
anticipated by Bernstein,2 as evidenced by the PDR.3

ANTICIPATION
The Examiner found that Bernstein disclosed the claimed method.
(Ans. 3.) In particular, the Examiner found that Bernstein taught:
In treating two young adults with Debrox® Drops to cleanse
their ears of earwax, I noted that blackheads, whiteheads,
and some acne papules and pustules in front of ears cleared
rapidly. I thought this might have resulted from spillage out of
the ear or inadvertent application of the eardrops to these areas.
Subsequently I tested topical formulations containing
carbamide peroxide for effectiveness in acne and found
surprisingly that carbamide peroxide applied topically to the
skin is useful in the treatment of acne vulgaris.

(Id. at 4.)(quoting Bernstein col. 1, ll. 38-43 with emphasis added). The
Examiner also found that Debrox® Drops, as evidenced by the PDR,
contains 6.5% carbamide peroxide in specially prepared anhydrous glycerol.
(Id.) Further, the Examiner found that the instant Specification explains that

2 US Patent No. 4,607,101 issued to Joel E. Bernstein, Aug. 19, 1986.
3 Physician’s Desk Reference, DEBROX® DROPS 1090 (34th ed. 1980).

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“[i]nflammatory acne vulgaris is characterized by the presence of
erythematous papules, pustules and cysts.” (Id.)(quoting Spec. [0006].)
Appellant contends that in Bernstein, “sole use of carbamide peroxide
was not shown to be effective against inflammatory acne.” (App. Br. 4.) In
support of this contention, Appellant asserts that Bernstein does not provide
any examples wherein patients that only had inflammatory lesions, i.e.,
pustules, cysts, and the like, were treated successfully with carbamide
peroxide as the sole active ingredient. (Id.) Appellant asserts that
Bernstein’s examples involving the use of carbamide peroxide alone only
relate to treating comedones, i.e., non-inflammatory acne vulgaris. (Id. at 5.)
According to Appellant, one of skill in the art reading Bernstein would not,
therefore, be led to use carbamide peroxide alone to treat patients with
inflammatory lesions. (Id. at 6.) Appellant asserts that, “[i]n contrast, the
present [application] specifically teaches unexpected success with carbamide
peroxide alone, for treating inflammatory lesions.” (Id.)
In further support of the contention that Bernstein did not teach that
carbamide peroxide alone treats inflammatory lesions, Appellant asserts that
two experts, Alan Shalita and Scott Phillips, opined that Bernstein taught
that carbamide peroxide was only useful by itself in treating comedonal acne
vulgaris, not inflammatory acne vulgaris. (Id. at 7.)
Additionally, Appellant asserts:
The Examiner has ignored or failed to review a number of
materials submitted after the Interview, including:
a. A chart of published acne studies showing that
vehicle treatment with the inactive ingredients of
Debrox by themselves produce reductions in
inflammatory acne lesions of up to 42%.
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Therefore, Debrox® is not solely carbamide
peroxide in terms of active ingredients.
b. The Examiner falsely contends that “at the time of
the ‘101 patent, there is no evidence that Debrox®
drops contained propylene glycol” even though the
inventor supplied the Examiner with the factual
evidence from the 1989 and 2005 Physicians'
Desk Reference that Debrox has always had the
same vehicle containing propylene glycol and
glycerin.

(Id. at 10.)

After considering the arguments and the evidence, we agree with the
Examiner that Bernstein disclosed treating inflammatory acne vulgaris with
carbamide peroxide as the sole active ingredient. As the Examiner and
Appellant agree (see, e.g., Ans. 4 and App. Br. 5), “[i]nflammatory acne
vulgaris is characterized by the presence of erythematous papules, pustules
and cysts” (Spec. [0006]). Bernstein discloses Debrox® Drops as an
example of a carbamide peroxide product. (Bernstein col. 1, ll. 29-31.)
Further, the Examiner provided evidence that carbamide peroxide is listed as
the only active ingredient in Debrox® Drops, which also contains a vehicle
suitable for topical application. (Ans. 4, citing PDR 1090.) Bernstein also
teaches that administering the product to a patient having “some acne
papules and pustules” in front of the ears resulted in the papules and pustules
clearing rapidly. (Bernstein col. 1, ll. 38-43). Anticipation is a finding of
fact. Titanium Metals Corp. v. Banner, 778 F.2d 775, 780 (Fed. Cir. 1985).
We find that these preceding facts alone anticipate the claimed invention.
See Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed.
Cir. 1987).
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Appellant’s arguments to the contrary are not persuasive. To begin,
Appellant’s assertion that the “sole use of carbamide peroxide was not
shown to be effective against inflammatory acne” (App. Br. 4) is not
supported by the evidence. As discussed, Bernstein disclosed that
carbamide peroxide drops rapidly cleared acne papules and pustules upon
application. (Bernstein col. 1, ll. 38-43.) This disclosure in the Background
of the Invention is not rendered immaterial because Bernstein chose not to
further exemplify this result in the Examples. See In re Chapman, 357 F.2d
418, 424 (CCPA 1966)(A reference can be used for all that it realistically
teaches, and is not limited to the disclosures in its specific examples.)
Nor is this factual disclosure overcome by Appellant’s assertion that
“experts, Alan Shalita and Scott Phillips, . . . opined that [Bernstein] taught
that carbamide peroxide was only useful by itself in treating comedonal acne
vulgaris, not inflammatory acne vulgaris.” (App. Br. 7.) The opinions
expressed by Appellant’s experts are contradicted by the express disclosure
in Bernstein that Debrox® Drops caused rapid clearing of acne papules and
pustules; i.e., effective treatment of inflammatory acne vulgaris. We
therefore decline to accord Appellant’s declarations significant weight as
rebuttal evidence. See In re American Acad. of Science Tech Ctr., 367 F.3d
1359, 1368 (Fed. Cir. 2004) (“The Board has broad discretion as to the
weight to give to declarations offered in the course of prosecution. See
Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (‘[A]ccord[ing]
little weight to broad conclusory statements [in expert testimony before the
Board] that it determined were unsupported by corroborating references
[was] within the discretion of the trier of fact to give each item of evidence
such weight as it feels appropriate.’).” (alterations in original)).
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Appellant also asserts that the Examiner “ignored or failed to review a
number of materials submitted” allegedly providing evidence that (a)
“Debrox® is not solely carbamide peroxide in terms of active ingredients,”
and (b) “Debrox has always had the same vehicle containing propylene
glycol and glycerin.” (App. Br. 10.) Regarding (a), Appellant refers to a
“chart of published acne studies showing that vehicle treatment with the
inactive ingredients of Debrox by themselves produce reductions in
inflammatory acne lesions of up to 42%.” (Id.) However, this “chart” is not
identified, nor is it seen in the exhibits included in the Evidence Appendix of
the Appeal Brief. Regarding (b), Appellant refers to “the 1989 and 2005
Physicians’ Desk Reference,” which is also not included in the exhibits
listed in Evidence Appendix of the Appeal Brief and, in any event, at best
shows the make-up of the Debrox® vehicle after the date of the Bernstein
disclosure. (Id.) It appears that Appellant’s argument regarding each of
these materials (a) and (b) relates to the vehicle in Debrox® Drops.
However, we note that independent claim 1 recites “a vehicle suitable for
topical application to the skin of a patient with such lesions,” without further
limitation regarding the properties of the selected vehicle. Appellant has not
explained why the vehicle in Debrox® Drops would not have simply met
this claim element.
Further, to the extent that Appellant asserts that “the present
[application] specifically teaches unexpected success with carbamide
peroxide alone, for treating inflammatory lesions,” (App. Br. 6), we do not
find that this assertion is supported by the evidence, as Bernstein disclosed
precisely such success. Moreover, evidence of unexpected results is not
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relevant to the issue of anticipation. In re Malagari, 499 F.2d 1297, 1302
(CCPA 1974).
Accordingly, we affirm the anticipation rejection of independent
claim 1. Claims 2 and 3 have not been argued separately and therefore fall
with independent claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

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

cdc