Ex Parte Bauman et al

Patent Trial and Appeal Board

Oct 12, 2017

14068747 (P.T.A.B. Oct. 12, 2017)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/068,747 10/31/2013 Susanne Bauman 9729-22TSCT 9649
20792 7590 10/13/2017
MYERS BIGEL, P.A.
PO BOX 37428
RALEIGH, NC 27627
EXAMINER
HAGHIGHATIAN, MINA
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
10/13/2017 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SUSANNE BAUMAN and NATHAN STASKO1
__________

Appeal 2017-002966
Application 14/068,747
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER,
and RYAN H. FLAX, Administrative Patent Judges.

SCHNEIDER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods for decreasing the production of sebum which have been rejected as
obvious and for obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellants identify the real party in interest as Novan, Inc. Br. 2.
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STATEMENT OF THE CASE
“Acne vulgaris is the most common skin disease in the United States.”
Spec. ¶ 3. “Due to its social impact, frequency of recurrence or relapse, and
necessary maintenance over a prolonged course of therapy, the American
Academy of Dermatologists have recommend that acne vulgaris be
reclassified and investigated as a chronic disease.” Id. One of the major
factors that lead to acne vulgaris is the overproduction of sebum by the
sebaceous gland. Id. at ¶ 4. The Specification describes a method for
decreasing the production of sebum sufficient to decrease or eliminate acne.
Id. at ¶ 9.
Claims 1 and 5–15 are on appeal. Claims 1 and 15 are the sole
independent claims and read as follows:
1. A method of decreasing sebum production in skin of a
subject comprising applying a nitric oxide (NO)-releasing
compound to the skin of a subject in an amount sufficient to
decrease sebum production.

15. A method of decreasing sebum production in skin of
a subject comprising applying to the subject a pharmaceutically
acceptable composition comprising a therapeutic agent, the
therapeutic agent consisting essentially of a nitric oxide (NO)-
releasing compound, wherein the NO-releasing compound is
present in the composition in an amount sufficient to decrease
sebum production in the skin of the subject.

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The claims stand rejected2 as follows:
Claims 1 and 5–15 has been rejected under 35 U.S.C. § 103(a) as
unpatentable over Perricone3 in combination with Peters4 in view of
Schoenfisch.5
Claims 1 and 5–15 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Cals-Grierson6 combined with Perricone and in view of
Schoenfisch.
Claims 1, 7, and 8 have been rejected for obviousness-type double
patenting over claims 20, 21, and 24 of the ’377 application.7
Claims 7 and 8 have been rejected for obviousness-type double
patenting over claims 31 and 32 of the ’928 application. 8

2 Claims 1 and 5–15 were rejected under 35 U.S.C. § 103(a) as unpatentable
over Peters in view of Schoenfisch. Final Act. 3. The rejection was
withdrawn by the Examiner. Ans. 2.
3 Perricone, US 2010/0186272 A1, published Nov. 11, 2010 (“Perricone”).
4 Peters, EP 1704876 A1, published Sept. 27, 2006 (“Peters”).
5 Schoenfisch et al., US 2009/0214617, published Aug. 27, 2009
(“Schoenfisch”).
6 Cals-Grierson and Ormerod, Nitric oxide function in the skin, 10 Nitric
Oxide 179 (2004) (“Cals-Grierson”).
7 USSN 14/381,377, filed Aug. 27, 2014 (“’377 application”). The ’377
Application went abandoned on Oct. 5, 2016 rendering this rejection moot.
8 USSN 13/256,928, filed Oct. 4, 2011 (“’928 application”). The ’928
application has issued as US 9,526,738 B2 on Dec. 27, 2016. Claims 31 and
32 issued as claims 21 and 22.
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OBVIOUSNESS
PERRICONE COMBINED WITH PETERS AND SCHOENFISCH
Issue
The issue with respect to this rejection is whether a preponderance of
evidence supports the Examiner’s conclusion that claims 12–15 would have
been obvious over Perricone combined with Peters and Schoenfisch.
The Examiner finds that Perricone teaches topical compositions
comprising a nitroalkene to prevent and treat skin conditions including acne
and seborrhea. Final Act. 6–7. The Examiner finds that Peters teaches the
use of a device for cosmetic treatment of the skin comprising a nitric oxide
eluting polymer. Id. at 7. The Examiner finds that Peters teaches the use of
an S-nitrated polymer, including the use of poly(ethylenimine)
diazeniumdiolate, to release nitric oxide in a controlled manner. Id. The
Examiner finds that Peters teaches the use of nitric oxide releasing
compound to treat hyperseborrhea. Id. at 8. The Examiner finds that
Schoenfisch teaches the preparation of nitric oxide releasing compounds
such as diazeniumdiolate, a nitrosamine, a hydroxylamine, a nitrosothiol, a
hydroxylamine, and a hydroxyurea that are co-condensed with silica. Id. at
9. The Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to have combined the
teachings of Schoenfisch et al with the combined teachings of
Perricone and Peters to arrive at the claimed invention. It
would have been obvious to do so because Perricone teach
topical administration of compositions comprising an effective
amount of nitroalkene to treat skin disorders such as seborrhea
and acne, Peters teach advantages of treating various skin
disorders such as hyperseborrhea and acne by application of a
NO donor compound such as nitrosylated polymers and
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diazeniumdiolates. Schoenfisch et al disclose that suitable NO
donors include a co-condensed silica network and
diazeniumdiolate and nitrosothiols and that the said
formulations are effective in treating subjects by both systemic
and topical administration. Thus it would have been obvious to
have combined the references in order to broaden the horizon
for treating patients and take advantage of disclosed
compositions and methods of topical administration of an
effective amount, as well as including the best types of NO
donor compounds.
Id. at 9–10.
Appellants contend that the references do not teach or suggest the use
of nitric oxide releasing compounds to decrease sebum production. Appeal
Br. 9. Appellants contend that, while Perricone teaches compounds for
treating acne, Perricone focuses on reducing inflammation and not deceasing
sebum production. Id. With respect to Peters, Appellants argue that, while
Peters mentions using nitric oxide to treat hyperseborrhea, Peters provides
no guidance as to how to decrease sebum production. Id. at 4–6. Appellants
argue that Schoenfisch does not teach the use of nitric oxide releasing
compounds to decrease sebum production. Id. at 7.
Findings of Fact
We adopt the Examiner’s findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
art. The following findings are included for emphasis and reference
purposes.
FF1. Perricone discloses:
Topical compositions comprising an effective amount of a
nitroalkene and a carrier are used to prevent skin conditions or
damage and to treat skin conditions and damage including
rosacea, eczema, psoriasis, xerosis, dermatitis, seborrhea,
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thermal and radiation burns (including sunburn), acne, alopecia,
skin aging, scars, and skin inflammation

Perricone, Abstract (emphasis added).
FF2. Perricone teaches that: “[s]ebum production favors proliferation
of the anaerobe Propionibacterium acnes, which is a normal commensal to
the pilobaceous unit, which can elicit hypersensitivity responses in acne.”
Perricone ¶ 92.
FF3. Perricone teaches that conventional treatment for acne
is directed at correcting the three major factors that
seem to cause acne: (1) androgenic stimulation of the sebaceous
glands and increased sebum production; (2) abnormal
keratinization and impaction in the pilosebaceous canal causing
obstruction to sebum flow; and (3) proliferation of P.
acnes.

Perricone ¶ 93
FF4. Perricone teaches that nitric oxide releasing compounds act as
lipid signaling mediators. Perricone ¶¶ 11, 14, and 16.
FF5. Seborrhea is an abnormally increased secretion and discharge of
sebum. Merriam-Webster, seborrhea, https://www.merriam-
webster.com/dictionary/seborrhea, Oct. 12, 2017.
FF6. Peters teaches a device for treating skin disorders comprising a
nitric oxide eluting polymer. Peters Abstract.
FF7. Among the disorders that can be treated with the device of
Peters are acne and hyperseborrhea. Peters Abstract and ¶ 58.
FF8. Schoenfisch discloses nitric oxide releasing particles and their
use in biomedical and pharmaceutical applications. Schoenfisch Abstract.
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FF9. Schoenfisch teaches that a nitric oxide releasing compound can
be co-condensed with a silane mixture. Schoenfisch ¶ 68–93.
Principles of Law
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.

In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
When determining obviousness, “the prior art as a whole must be
considered. The teachings are to be viewed as they would have been viewed
by one of ordinary skill.” In re Hedges, 783 F.2d 1038, 1041, (Fed. Cir.
1986).
Analysis
We find the Examiner has established that the claims would have been
obvious over Perricone combined with Peters and Schoenfisch. Appellants
have not produced evidence showing, or persuasively argued, that the
Examiner’s determinations on obviousness are incorrect. Only those
arguments made by Appellants in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(1)(iv) (2015). We have identified claim 1 as representative. We
address Appellants’ arguments below.
Appellants contend that the references do not teach or suggest the use
of nitric oxide to reduce production of sebum. Appeal Br. 9. Appellants
contend that Perricone is focused on preventing and reducing inflammation
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and not decrease in sebum production. Appeal Br. 9. With respect to Peters,
Appellants argue that, while Peters mentions treating hyperseborrhea, Peters
gives no guidance as to how to decrease sebum production using a nitric
oxide releasing compound. Appeal Br. 6. Appellants argue that
Schoenfisch is silent about using nitric oxide releasing compounds to
decrease sebum production. Id. at 7.
We have considered Appellants’ argument and find them
unpersuasive. Perricone teaches the use of nitric oxide releasing compounds
to treat seborrhea, which is defined as an excess production of sebum. FF1
& 4. Perricone also teaches that the nitric oxide releasing compounds act as
lipid signaling mediators. FF2. Similarly Perricone teaches the use of the
nitric oxide compounds to treat acne. FF1. Perricone also teaches that one
of the factors causing acne is increase sebum production. FF2 & 3.
Similarly Peters teaches the use of nitric oxide eluting compounds to treat
hyperseborrhea and acne. FF7. We agree with the Examiner that the
teachings of Perricone and Peters “would have [] been sufficient to lead one
skilled in the art to determine that a topical administration of an NO
releasing compound will reduce sebum production in the skin.” Ans. 4.
While claim 15 has been argued separately, the arguments presented
are essentially the same as those presented for claim 1 discussed above.
Appeal Br. 10. We, therefore, affirm the rejection of claim 15 for the
reasons stated above regarding claim 1.
Turning to claim 8, Appellants argue that none of the references teach
the use of N-diazeniumdiolate co-condensed with polysiloxane
macromolecules to decrease sebum production. Id. at 12–13. We are
unpersuaded. As discussed above, Perricone and Peter teach the use of nitric
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oxide eluting compounds to decrease sebum production. Schoenfisch
teaches the use on N-diazeniumdiolates co-condensed with siloxane
macromolecules for topical administration. Schoenfisch ¶¶ 58–63 and 327.
We agree with the Examiner that it would have been obvious to one skilled
in the art to use the specific compound disclosed in Schoenfisch in the
methods of Perricone and Peters.
With respect to claim 9, Appellants contend that none of the
references teaches the use of nitrosothiol-functionalized macromolecules.
Appeal Br. 13. Again we are unpersuaded. Schoenfisch teaches the use of
nitrosothiols. Schoenfisch ¶¶ 63, 229, and 304.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 1, 8, 9, and 15 would have been obvious
over Perricone combined with Peters and Schoenfisch.
Claims 5–7 and 11–14 have not been argued separately and therefore,
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).

CALS-GRIERSON COMBINED WITH PERRICONE AND SCHOENFISCH
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 1 and 5–15
would have been obvious over Cals-Grierson combined with Perricone and
Schoenfisch.
The Examiner finds that Cals-Grierson teaches that nitric oxide
appears to regulate lipolysis since the nitric oxide inhibition reduces
lipolysis. Final Act. 11. The Examiner also finds that Cals-Grierson teaches
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the topical application of diazeniumdiolates, which can liberate nitric oxide
in a controlled fashion, was being explored to determine their therapeutic
value. Id. The Examiner finds that Perricone teaches the use of nitric oxide
eluting compounds to treat acne and seborrhea. Id. The Examiner finds that
Schoenfisch discloses certain nitric oxide releasing particles that comprise
nitric oxide donor compounds co-condensed with a silica network. The
Examiner finds that the nitric oxide donors include diazeniumdiolate and
nitrosothiols. The Examiner concludes that
It would have been obvious to one of ordinary skill in the
art at the time the invention was made to have combined the
teachings of Schoenfisch et al with the combined teachings of
Gals-Grierson et al and Perricone to arrive at the claimed
invention. It would have been obvious to do so because Gals-
Grierson et al teach that topical application of a NO-releasing
composition including diazeniumdiolates, regulates lipolysis,
Perricone teach topical administration of compositions
comprising an effective amount of nitroalkene to treat skin
disorders such as seborrhea and acne and Schoenfisch et al
disclose that suitable NO donors include a co-condensed silica
network and diazeniumdiolate and nitrosothiols and that the
said formulations are effective in treating subjects by both
systemic and topical administration. Thus it would have been
obvious to have combined the references in order to broaden the
horizon for treating patients and take advantage of disclosed
compositions and methods of topical administration of an
effective amount, as well as including the best types of NO
donor compounds.
In other words, all the claimed elements were known in
the prior art and one skilled in the art could have combined the
elements as claimed by known methods with no change in their
respective functions, and the combination would have yielded
predictable results to one of ordinary skill in the art at the time
of the invention.
Id. at 12–13.
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Appellants contend that Cals-Grierson does not teach or suggest the
use of nitric oxide eluting compounds to decrease sebum production.
Appeal Br. 11. Appellants reiterate their arguments that neither Perricone
nor Schoenfisch teaches the use of nitric oxide eluting compounds to
decrease sebum production and that one skilled in the art would not have a
reasonable expectation of success in reducing sebum production. Id.
Findings of Fact
We adopt the Examiner’s findings as our own, including with regard
to the scope and content of, and motivation to modify or combine, the prior
art. The following findings are included for emphasis and reference
purposes.
FF10. Cals-Grierson teaches that
Adipocytes are the fat storage cells of the hypodermis.
In rodents, these cells express NOS3 and can be activated
to express NOS2. In this cell type, the endogenously
produced NO appears to be involved in the
regulation of lipolysis, since NOS inhibition significantly
reduces lipolysis, via a mechanism of action that involves
cytoplasmic oxidation.

Cals-Grierson 182, citation omitted.
Analysis
We find the Examiner has established that the claims would have been
obvious over Cals-Grierson combined with Perricone and Schoenfisch.
Appellants have not produced evidence showing, or persuasively argued,
that the Examiner’s determinations on obviousness are incorrect. Only those
arguments made by Appellants in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
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§ 41.37(c)(1)(iv) (2015). We have identified claim 1 as representative. We
address Appellants’ arguments below.
Appellants argue that the references, and in particular Cals-Grierson,
do not teach or suggest the use of nitric oxide to decrease sebum production.
We are unpersuaded. As the Examiner points out, Cals-Grierson teaches the
positive effects nitric oxide has on the skin and in particular that nitric oxide
regulates lipolysis. Ans. 6, FF10. We agree with the Examiner that when
the teachings of Cal-Grierson are combined with the teachings of Perricone
regarding nitric oxide acting as a lipid signaling mediator, one skilled in the
art would deduce that topical administration of a nitric oxide releasing
compound would be effective in reducing sebum production. Ans. 6. We
also agree with the Examiner that “one of ordinary skill in the art would
have had a reasonable expectation of success from the combined teachings
of the references in reducing sebum production in the skin by topical
administration of an NO releasing/donating compound.” Id.
While claim 15 has been argued separately, the arguments presented
are essentially the same as those presented for claim 1 discussed above.
Appeal Br. 12. We, therefore, affirm the rejection of claim 15.
With respect to claims 8 and 9, Appellants present the same
arguments for these claims for both obviousness rejections. Appeal Br. 12–
13. For the reason sated above, we find these arguments unpersuasive.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 1, 8, 9, and 15 would have been obvious
over Cal-Grierson combined with Perricone and Schoenfisch.
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Claims 6, 7, and 10–14 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).

OBVIOUSNESS-TYPE DOUBLE PATENTING
’928 APPLICATION
Issue
The issue with respect to this rejection is whether the evidence or
records supports the Examiner’ conclusion that claims 7 and 8 of the present
application are not patentably distinct from claims 31 and 32 of the ’928
application.
The Examiner finds that the claims of both applications are drawn to
application of nitric oxide releasing compound to the skin. Final Act. 15.
The Examiner finds that the claims of the instant application are drawn to
decreasing sebum production whereas the claims of the ’928 application are
drawn to treating acne. Id. The Examiner goes on to find that since excess
sebum is one factor or cause of acne, it would have been obvious to one
skilled in the art that decreasing sebum production will result in treating or
preventing acne. Id.
Appellants contend that clams 31 and 32 of the ’928 application fail to
render pending claims 7 and 8 obvious as a method of treating acne does not
teach or suggest a method for reducing sebum. Appeal Br. 14.
Analysis
We first note that the ’928 application issued as US 9,526,738 B2 on
Dec. 27, 2016. Claims 31 and 32 of the application correspond, generally, to
claims 20 and 21 of the issued patent.
We agree with the Examiner’s that the claims 7 and 8 are not
patentably distinct from claims 31 and 32 of the ’928 application (or 20 and
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21 of the issued patent). Both of the appealed and issued claims are directed
to the topical application of nitric oxide releasing compounds to treat skin
conditions. Compare claims 7 and 8 of the present application, id. at 16
(Claims App’x), with claims 31 and 32 of the ’928 application. The
difference is that claims 31 and 32 of the ’928 application are directed to
treating acne9, whereas claims 7 and 8 of the present application are directed
to decreasing sebum production. We agree with the Examiner that the two
methods include the same step, the same composition and achieve the same
result. Ans. 11.
Conclusion of Law
We conclude that the evidence of record supports the Examiner’s
conclusion that claims 7 and 8 are not patentably distinct over claims 31 and
32 of the ’928 application.
SUMMARY
We affirm the rejections under 35 U.S.C. § 103(a).
We affirm the rejection of claims 7 and 8 for obviousness-type double
patenting

9 While we note that the scope of the claims as issued are different that the
scope at the time the rejection was made, the claims of the issued patent are
still directed to the use of a nitric oxide releasing compounds to treat acne.
See, US 9,526,738 B2, claims 1, 10, 21, and 22. However, the issued
species anticipates, and therefore renders obvious, the current generic
claims. See Atofina v. Great Lakes Chemical Corp., 441 F.3d 991, 999 (Fed.
Cir. 2006) (“Titanium Metals stands for the proposition that an earlier
species reference anticipates a later genus claim.”)
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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