SANOFI - TOPAZ, INC.

Patent Trials and Appeals Board

Jul 8, 2020

14572664 - (D) (P.T.A.B. Jul. 8, 2020)

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.
14/572,664 12/16/2014 Nicholas Spring 18873.105127 1903
20786 7590 07/08/2020
KING & SPALDING
1180 PEACHTREE STREET , NE
ATLANTA, GA 30309-3521
EXAMINER
BARHAM, BETHANY P
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
07/08/2020 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
ATLIPDOCKETING@kslaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte NICHOLAS SPRING and GARRY T. GWOZDZ
____________

Appeal 2020-000846
Application 14/572,664
Technology Center 1600
____________

Before DONALD E. ADAMS, ELIZABETH A. LAVIER, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals2 from Examiner’s
decision to reject claims 1–10, 21–23, and 25–27 (Appeal Br. 5; see also
Office Act.3 2). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as “Arbor
Pharmaceuticals” (Appellant’s March 28, 2019 Appeal Brief (Appeal Br.)
3).
2 This Appeal is related to Appeal 2019-005431 (Application 15/408,924)
(see Appeal Br. 4).
3 Examiner’s July 2, 2018 Non-Final Office Action.
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STATEMENT OF THE CASE
Appellant’s disclosure “relates to topical formulations containing
avermectin for use in the prophylactic and therapeutic treatment of a head
lice infestation in humans” (Spec.4 ¶ 2). Claims 1–3, 5, 21–23, and 25 are
reproduced below:
1. A topical pediculicidal formulation comprising about 0.1%
to about 2.0% by weight ivermectin, a solubilizer, olive oil, a
non-ionic surfactant, and about 30% to 40% by weight water.
(Suppl. Appeal Br.5 2.)
2. The topical pediculicidal formulation of claim 1, comprising
about 0.5% by weight ivermectin.
(Id.)
3. The topical pediculicidal formulation of claim 1, further
comprising shea butter.
(Id.)
5. The topical pediculicidal formulation of claim 1, further
comprising one or more paraben preservatives.
(Id.)
21. The topical pediculicidal formulation of claim 5, wherein
the paraben preservative is selected from the group consisting
of methylparaben, propylparaben, ethylparaben, butylparaben,
isobutylparaben, isopropylparaben, benzylparaben, sodium salts
thereof, and any combination thereof.
(Id. at 3.)
22. The topical pediculicidal formulation of claim 21, wherein
the formulation has a rate of killing permethrin resistant SF-HL

4 Appellant’s December 16, 2014 Specification.
5 Appellant’s May 24, 2019 Supplemental Appeal Brief.
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head lice that is 3.2 to 3.8 times faster than ivermectin in
solution at the same weight%, wherein the solution is water.
(Id.)
23. The topical pediculicidal formulation of claim 1, wherein
the formulation is indirectly ovicidal.
(Id.)
25. The topical pediculicidal formulation of claim 2, wherein
the shea butter is present from about 1% to about 5% by weight.

Grounds of rejection before this Panel for review:
Claim 25 stands rejected under 35 U.S.C. § 112(b).
Claims 1, 2, 4–10, 21–23, 26, and 27 stand rejected under 35 U.S.C.
§ 103 as unpatentable over the combination of Manetta6 and Hittel.7
Claims 1–10, 21–23, and 25–27 stand rejected under 35 U.S.C. § 103
as unpatentable over the combination of Manetta, Hittel, Patt,8 and
Diembeck.9
Claims 1–10, 21–23, and 25–27 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1, 4–8, and 23–25 of Spring ’153.10
Claims 1–10, 21–23, and 25–27 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1, 14–18, 21–25, and 39–41 of Spring ’595.11

6 Manetta et al., WO 2004/093886 A1, published Nov. 4, 2004.
7 Hittel, US 6,136,806, issued Oct. 24, 2000.
8 Patt, US 6,927,206 B2, issued Aug. 9, 2005.
9 Diembeck et al., WO 98/36730, published Aug. 27, 1998.
10 Spring et al., US 8,791,153 B2, issued July 29, 2014.
11 Spring et al., US 8,927,595 B2, issued Jan. 6, 2015.
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DEFINITENESS:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that the phrase “the shea butter,” as set forth in Appellant’s claim 25, lacks
antecedent basis?
ANALYSIS
Examiner finds that Appellant’s claim 25 depends from Appellant’s
claims 1 and 2 and neither Appellant’s claim 1 nor 2 refer to shea butter
(Office Act. 3). In addition, Examiner finds that Appellant does not contest
this rejection (see Ans.12 3 (Examiner finds that “Appellant presents no
arguments with respect to the rejection of claim 25 under [35 U.S.C.
§] 112(b)”)).
“If a ground of rejection stated by the examiner is not addressed in
the appellant’s brief, appellant has waived any challenge to that ground of
rejection and the Board may summarily sustain it.” Manual of Patent
Examining Procedure (MPEP) § 1205.02 (9th Ed., Rev. 08.2017 (Jan. 2018)).
Accordingly, this rejection is summarily affirmed.
CONCLUSION
The preponderance of evidence supports Examiner’s conclusion that
the phrase “the shea butter,” as set forth in Appellant’s claim 25, lacks
antecedent basis. The rejection of claim 25 under 35 U.S.C. § 112(b) is
affirmed.

12 Examiner’s September 9, 2019 Answer.
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OBVIOUSNESS:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Manetta discloses a pharmaceutical composition that may be in the
form of a cream or gel (Manetta 4:7–14; see id. at 4:13 (Manetta discloses
shampoo formulations); Office Act. 4; cf. Suppl. Appeal Br. 2 (Appellant’s
claim 10 depends from and further limits the formulation of Appellant’s
claim 1 to “a cream, gel or pomade”)).
FF 2. Manetta discloses a composition comprising: a) an oily phase
comprising fatty substances; b) at least one surfactant-emulsifier;
c) ivermectin; d) one or more solvent(s) and/or propenetrating agent(s) for
the active agent; e) one or more gelling agent(s); and f) water (see Manetta
6:15–23; see also Office Act. 4–5).
FF 3. Manetta discloses that the “oily phase” of its composition “may
comprise, for example, vegetable, mineral, animal or synthetic oils, silicone
oils, Guerbert alcohols or other substances, and mixtures thereof” (Manetta
6:24–7:2; see also id. at 7:7–9 (Manetta discloses that the vegetable oil may
be “sweet almond oil, palm oil, soybean oil, sesame oil and sunflower oil”);
Office Act. 4).
FF 4. Manetta discloses that “[t]he oily phase . . . may be present at a
content of between 3 and 50% by weight relative to the total weight of the
composition” (Manetta 8:19–22).
FF 5. Manetta discloses that its composition “advantageously comprises up
to 15% by weight of suitable surfactant-emulsifier” (Manetta 9:14–16).
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FF 6. Manetta discloses that its “composition . . . comprises from 0.001 to
10%[, preferably 0.1 to 5%,] of ivermectin by weight relative to the total
weight of the composition” (Manetta 9:20–22; see Office Act. 4).
FF 7. Manetta discloses that its “composition . . . contains from 0.1 to
20% . . . of a solvent and/or propenetrating agent for the ivermectin active
agent” (Manetta 10:9–11).
FF 8. Manetta discloses that its “composition . . . may also comprise
aqueous phase gelling compounds ranging from 0.01 to 5% by weight
relative to the total weight of the composition” (Manetta 10:13–16).
FF 9. Manetta discloses that its “composition . . . contains water ranging
from 30 to 95%” (Manetta 11:25–26; see Office Act. 4).
FF 10. Manetta exemplifies a composition comprising:

(Manetta 21–22; see Office Act. 4 (Examiner finds that “[o]leyl alcohol,
cetyl alcohol, stearyl alcohol, methylparaben (methyl para-
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hydroxybenzoate), and propylparaben (propyl para-hydroxybenzoate)
are . . . [examples of] nonionic surfactants and paraben preservatives” and
solvents “include propylene glycol, ethanol, isopropanol, butanol, N-methyl-
2-pyrrolidone, or DMSO, polysorbate 80, phenoxyethanol, and mixtures
thereof”).)
FF 11. Manetta discloses that ivermectin is known as an “antiparasitic
medicinal product for veterinary use” and is effective against, inter alia,
some lice (Manetta 1:21–27).
FF 12. Manetta “relates to the use of ivermectin for producing a topical
pharmaceutical composition intended for the treatment of rosacea” (Manetta
1:3–5; Office Act. 4).
FF 13. Examiner finds that Manetta does “not teach olive oil in its
composition” (Office Act. 5).
FF 14. Hittel “relates to a treating agent for rosacea” that is formulated into
a pharmaceutical composition (Hittel 1:4–5; id. at 2:61–66; see Office Act.
5).
FF 15. Hittel discloses that its composition can be formulated as a gel or
cream for external topical use, wherein such an external preparation
comprises an oily base or a mixture of two or more oily bases, which
include, for example, “peanut oil, sesame oil, soybean oil, safflower oil,
avocado oil, sunflower oil, corn oil, rape seed oil, cotton seed oil, castor oil,
camellia oil, palm oil, olive oil, poppy seed oil, [and] coconut oil” (Hittel
3:9–12; see id. at 3:64–4:4; see also Office Act. 5).
FF 16. Examiner finds that the combination of Manetta and Hittel do not
suggest a composition comprising shea butter (see Office Act. 8).
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FF 17. Patt “relates to the treatment of a dermatological condition and, more
specifically, to the treatment of rosacea, by topical application of a
composition comprising a peptide copper complex” (Patt 1:8–11; see Office
Act. 8).
FF 18. Patt discloses a topical composition comprising: (a) a carrier, (b) at
least one peptide copper complex, and (c) a skin lightening agent, a
sunscreen agent, a skin conditioning agent, a skin protectant, an emollient, a
humectant, or a mixture thereof (Patt 2:4–11; see Office Act. 8).
FF 19. Patt discloses:
An emollient[, such as mineral oil or shea butter
glycerides,] . . . is a cosmetic ingredient that can help skin
maintain a soft, smooth, and pliable appearance. Emollients are
able to provide these benefits, largely owing to their ability to
remain on the skin surface, or in the stratum corneum, to act as
a lubricant and reduce flaking.
(Patt 11:31–61; see Office Act. 8.)
FF 20. Examiner finds that Diembeck discloses compositions for use in the
treatment of rosacea that comprise, inter alia, 2 wt. % shea butter (see Office
Act. 8).
ANALYSIS
Claim Interpretation:
Appellant’s only independent claim, claim 1, is drawn to a
formulation, i.e. composition (see Suppl. Appeal Br. 2). The claimed
composition comprises: (a) about 0.1% to about 2.0% by weight ivermectin,
(b) a solubilizer, (c) olive oil, (d) a non-ionic surfactant, and (e) about 30%
to 40% by weight water (id.). The foregoing limitations, set forth in the
body of Appellant’s claim 1, define a structurally complete invention.
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The preamble of Appellant’s claim 1 recites the intended use of the
claimed composition, by characterizing the claimed composition as a
“topical pediculicidal formulation” (id.). In this regard, we note that the
absence of the phrase “topical pediculicidal” from the preamble of
Appellant’s claim 1 does “not affect the structural definition . . . of the
[formulation, i.e. composition, as is set forth in the body of the claim] itself.”
See Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 810
(Fed. Cir. 2002). Stated differently, the formulation, as claimed, does not
change simply by naming it a topical pediculicidal formulation, or otherwise
stating its purpose or intended use.
A “preamble is not limiting where a patentee defines a structurally
complete invention in the claim body and uses the preamble only to state a
purpose or intended use for the invention.” Catalina, 289 F.3d at 808
(citations omitted); see also Boehringer Ingelheim Vetmedica, Inc. v.
Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (“[A]
preamble simply stating the intended use or purpose of the invention will
usually not limit the scope of the claim, unless the preamble provides
antecedents for ensuing claim terms and limits the claim accordingly.”);
Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (“[W]here a patentee
defines a structurally complete invention in the claim body and uses the
preamble only to state a purpose or intended use for the invention, the
preamble is not a claim limitation.”); In re Schreiber, 128 F.3d 1473, 1475
(Fed. Cir. 1997) (finding preamble language reciting a dispensing top “for
passing only several kernels of a popped popcorn at a time” not limiting
because it did not impose any structural limitations on the claimed
dispenser); In re Taylor, 484 F. App’x 540, 541 (Fed. Cir. 2012) (finding
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preamble language reciting a mix “for making low-calorie, palatable food or
food components” non-limiting because it did not impose any structural
limitations on the claimed mix).

The rejection over the combination of Manetta and Hittel:
Initially, we acknowledge Appellant’s contention that “Examiner has
not addressed . . . the level of ordinary skill in the art” (Appeal Br. 10 and
22; Reply Br. 3 (Appellant contends that Examiner “failed to resolve the
level of ordinary skill in the art”); see also Appeal Br. 12–14). Appellant’s
contention, however, is not persuasive because the prior art relied upon by
Examiner is representative of the level of ordinary skill in this art. See
Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“[T]he absence
of specific findings on the level of skill in the art does not give rise to
reversible error ‘where the prior art itself reflects an appropriate level and a
need for testimony is not shown.”’ (Quoting Litton Indus. Prods., Inc. v.
Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).
As discussed above, Appellant’s only independent claim, claim 1, is
drawn to a composition comprising: (a) about 0.1% to about 2.0% by
weight ivermectin, (b) a solubilizer, (c) olive oil, (d) a non-ionic surfactant,
and (e) about 30% to 40% by weight water (see Suppl. Appeal Br. 2).
Similarly, Manetta discloses a topical composition comprising: (a) from
0.001% to 10% by weight ivermectin, (b) a solubilizer, (c) an oily phase
comprising an oil such as sesame oil, soybean oil, sunflower oil, or palm oil,
(d) a non-ionic surfactant, and (e) from 30% to 95% water (see FF 1–10). In
addition, although Manetta discloses that ivermectin compositions are
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known to be effective against some lice, Manetta discloses that its
composition is “intended for the treatment of rosacea” (see FF 11–12).
Examiner recognizes that Manetta does not disclose a composition
comprising olive oil, but finds that Hittel discloses a topical composition for
the treatment of rosacea that, like Manetta, comprises an oily phase
comprising an oil such as sesame oil, soybean oil, sunflower oil, palm oil or
olive oil (see FF 14–15; cf. FF 2–3).
Thus, Examiner concludes, based on the combination of Manetta and
Hittel, that, at the time Appellant’s invention was made, it would have been
prima facie obvious to use olive oil, as disclosed by Hittel, for the oily phase
oil in Manetta’s composition, because Manetta and Hittel both disclose a
topical composition, such as a cream or gel, for the treatment of rosacea,
which comprises, inter alia, an oily phase composed of the same or similar
oils (see Office Act. 5 (citing In re Fout, 675 F.2d 297, 301 (CCPA 1982)
(“Express suggestion to substitute one equivalent for another need not be
present to render such substitution obvious.”); see also FF 1–15).
We find no error in Examiner’s prima facie case of obviousness.

Claim 1:
Appellant’s contention that “not every formulation of ivermectin is
pediculicidal” at least to some degree, lacks an evidentiary basis on this
record and is, therefore, not persuasive (see Appeal Br. 22). See In re
Pearson, 494 F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a
brief cannot take the place of evidence.”).
For the foregoing reasons, we find that the intended use of Appellant’s
composition, as set forth in the preamble of Appellant’s claim, is not
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“necessary to give life, meaning and vitality to the claim[].” See Kropa v.
Robie, 187 F.2d 150, 152 (CCPA 1951) (The language in a preamble will be
given effect if it is “necessary to give life, meaning and vitality to the
claims.”). Therefore, we are not persuaded by Appellant’s contention that
the “term ‘pediculicidal,’” as recited in the preamble of its claim 1, further
limits the claimed composition (see Appeal Br. 22; Reply Br. 4–7; cf. Ans.
4–5).
We are not persuaded by Appellant’s contention that Manetta and
Hittel are non-analogous art and, therefore, Examiner erred by relying upon
these references to support the obviousness rejection on this record (see
Appeal Br. 22–25; see also Reply Br. 8–11). Two criteria have evolved for
determining whether prior art is analogous: (1) whether the art is from the
same field of endeavor, regardless of the problem addressed, and (2) if the
reference is not within the field of the inventor’s endeavor, whether the
reference still is reasonably pertinent to the particular problem with which
the inventor is involved. In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992).
On this record, Manetta and Hittel relate to the formulation of topical
compositions for the treatment of rosacea (see FF 1–20). As discussed
above, ivermectin is effective as the active agent in compositions for the
treatment of rosacea (see, e.g., FF 2). Thus, those of ordinary skill in this art
would have found these references pertinent to the particular problem with
which Appellant is involved, i.e. formulating “a topical . . . [composition]
compris[ing] a pharmaceutically effective amount of an avermectin
compound, solubilizers, suspending agents, preservatives, non-ionic
surfactants, humectants, and water” (see Spec. ¶ 28; see also Appeal Br. 23–
24 (Appellant contends that the particular problem to which it was
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concerned is the development and introduction of a topical formulation that
is safe, effective, convenient to use, and not previously marketed for
Appellant’s intended use); Ans. 5–7).
Manetta and Hittel both disclose topical cream or gel formulations of
ivermectin that comprise, inter alia, an oily phase (see FF 2, 3, 14, and 15).
Manetta and Hittel both disclose that appropriate oils for this oily phase may
be sesame oil, soybean oil, sunflower oil, or palm oil (id.). Hittel further
discloses that olive oil may also be an appropriate oil for the oily phase of
topical cream or gel formulations of ivermectin (see FF 14–15). Thus,
notwithstanding Appellant’s contention to the contrary, Examiner’s reliance
on equivalency to support a conclusion would have been prima facie obvious
to use Hittel’s olive oil as the oily phase in Manetta’s composition is
supported by the evidence relied upon by Examiner (see FF 2, 3, 14, and 15;
see also Ans. 7–8; cf. Appeal Br. 25; Reply Br. 11–12).
We are not persuaded by Appellant’s contention that a person of
ordinary skill in this art would not have selected olive oil from Hittel’s
disclosure of appropriate oils for the oily phase of topical cream or gel
formulations of ivermectin for use in Manetta’s composition for the same
purpose (Appeal Br. 25 and 26–28; cf. Ans. 8–9; Reply Br. 12–17). Sinclair
& Carroll Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945) (“Reading a
list and selecting a known compound to meet known requirements is no
more ingenious than selecting the last piece to put into the last opening in a
jig-saw puzzle. It is not invention.”).
The amount of water in Manetta’s composition encompasses and,
therefore, makes obvious the water concentration recited in Appellant’s
claim (see Suppl. Appeal Br. 2). See Iron Grip Barbell Co. v. USA Sports,
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Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (“[W]here there is a range
disclosed in the prior art, and the claimed invention falls within that range,
there is a presumption of obviousness.”). Therefore, we are not persuaded
by Appellant’s contention that “Manetta fails to render obvious the amount
of water recited in claim 1” (Appeal Br. 29; Reply Br. 17; cf. Ans. 10–11).

Claims 22–23:
As discussed above, Manetta discloses a topical composition
comprising: (a) from 0.001% to 10% by weight ivermectin, (b) a solubilizer,
(c) an oily phase comprising an oil such as sesame oil, soybean oil,
sunflower oil, or palm oil, (d) a non-ionic surfactant, and (e) from 30% to
95% water (see FF 1–10). The amount of ivermectin and water in Manetta’s
composition encompasses the concentrations as recited in Appellant’s claims
(see Suppl. Appeal Br. 3). See Iron Grip Barbell Co., 392 F.3d at 1322
(“[W]here there is a range disclosed in the prior art, and the claimed
invention falls within that range, there is a presumption of obviousness.”).
In addition, Manetta discloses that its composition may be formulated as a
shampoo (see FF 1). Thus, the evidence on this record supports a conclusion
that if Manetta’s composition were used as a topical pediculicidal
formulation, the killing rate and ovicidal activity recited in Appellant’s
claims 22–23 would have been inherent in Manetta’s composition (see FF 1–
12; cf. Appeal Br. 26; Reply Br. 13–14).
Furthermore, we find no evidence on this record to support a
conclusion that the selection of olive oil from Hittel’s disclosure of
appropriate oils for the oily phase of topical cream or gel formulations of
ivermectin for use in Manetta’s composition for the same purpose would
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affect the activity of Manetta’s active agent, ivermectin, for any purpose (see
FF 1–15).
Where, as here, the claimed and prior art products are identical
or substantially identical, or are produced by identical or
substantially identical processes, 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.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (footnote omitted).
For the foregoing reasons, we are not persuaded by Appellant’s
unsupported contention that Examiner failed “to meet the high standard
required to rely on inherency, at least because the components ingredients in
the prior art are not provided in the same combination, in the same amounts
or the applied to the same site of action as presently claimed.” (Appeal Br.
26; see also Reply Br. 7–8).

Secondary Considerations:
Appellant contends that it “provided evidence (including evidence of
unexpected results) that [its] claims . . . are non-obvious over Manetta in
view of Hittel,” because “one of ordinary skill would not have been
motivated to substitute the olive oil disclosed in Hittel for the fatty
substances disclosed in Manetta[] as required by all pending claims”
(Appeal Br. 26; see Spec. ¶¶ 102–134). In this regard, in addition to
Appellant’s contentions discussed above, Appellant contends that:
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[O]ne of skill in the of skill in the art would understand that
numerous substances disclosed . . . [by Hittel as appropriate oils
for the oily phase in a topical cream or gel formulation of
ivermectin] are unsuitable for use in treating patients with
rosacea-including but not limited to olive oil. Notably, olive oil
has a high oleic acid (OA) to linoleic (LA) acid ratio, where
high OA concentrations can damage the skin barrier and cause
irritation. Tanojo H. et al. Journal of Controlled Release, Vol.
58, Issue 1, 8 March 1999, Pages 97- 104. This is in contrast to
various other oily components disclosed in Hittel. Sunflower
oil (which is preferred for use on the skin) contains about 23%
oleic acid and about 66% linoleic acid. Moreover, there could
be no reasonable expectation of success if the product causes
damage to the skin barrier and irritation, particularly given the
need to treat children. . . . Appellant[] . . . submitted the Tanajo
reference as objective evidence of [non-obviousness].
(Appeal Br. 28; see id. (citing Spec. ¶ 27) (Appellant contends that its
Specification “describes one goal of the present invention as providing a
product that is ‘safe, will appeal to the patient for ease of use’.”) Appellant,
however, does not identify, and we do not find, a disclosure in Tanojo of
olive oil, sunflower oil, or any other oil. Appellant also did not identify, and
we do not find, a disclosure of rosacea in Tanojo. Thus, we are not
persuaded by Appellant’s unsupported contentions relating to evidence of
non-obviousness or unexpected results (see Appeal Br. 28; Reply Br. 17–18;
cf. Ans. 9–11). See Pearson, 494 F.2d at 1405 (“Attorney’s argument in a
brief cannot take the place of evidence.”).
Appellant also fails to direct our attention to a comparison of their
claimed formulation against the closest prior art, i.e. Manetta. See In re
Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen
unexpected results are used as evidence of nonobviousness, the results must
be shown to be unexpected compared with the closest prior art.”).
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Therefore, we are not persuaded by Appellant’s contention that it
“demonstrated unexpected results, in the form of data showing the superior
pediculicidal properties of the claimed formulation,” which “shows that lice
treated with the [claimed] composition would exhibit a faster mortality rate
response than lice treated with unformulated 0.5% ivermectin” (Appeal Br.
29; Reply Br. 18). Appellant failed to establish an evidentiary basis on this
record to support its inference that its evidence of unexpected results is
“relevant to the issue of unexpected results over the closest prior art” (see
Appeal Br. 29; Reply Br. 18). Therefore, we are not persuaded by
Appellant’s contentions regarding unexpected results.

The rejection over the combination of Manetta, Hittel, Patt, and Diembeck:
Based on the combination of Manetta, Hittel, Patt, and Diembeck,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious to incorporate shea butter into the
compositions suggested by the combination of Manetta and Hittel, because
Patt and Diembeck disclose shea butter, like Manetta’s fatty substances, is
useful as an emollient in topical compositions for rosacea treatment (Office
Act. 8; see FF 1–20). We find no error in Examiner’s prima facie case of
obviousness.

Claim 1:
For the reasons set forth above, we find no error in Examiner’s
conclusion that the combination of Manetta and Hittel makes obvious
Appellant’s claim 1. See In re Kronig, 539 F.2d 1300, 1302 (CCPA 1976)
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(In affirming an obviousness rejection, the Board may rely upon less than all
the references cited by the Examiner.).

Claim 3:
As discussed above, Appellant’s claimed invention is drawn to a
composition not a method of treating lice. In this regard, Patt and
Diembeck, like Manetta and Hittel, relate to the formulation of topical
compositions for the treatment of rosacea (see FF 1–20). As discussed
above, ivermectin is effective as the active agent in compositions for the
treatment of rosacea (see, e.g., FF 2). Thus, those of ordinary skill in this art
would have found these references pertinent to the particular problem of
with which Appellant is involved, i.e. formulating “a
topical . . . [composition] compris[ing] a pharmaceutically effective amount
of an avermectin compound, solubilizers, suspending agents, preservatives,
non-ionic surfactants, humectants, and water” (see Spec. ¶ 28; see also
Appeal Br. 23–24 (Appellant contends that the particular problem to which
it was concerned is the development and introduction of a topical
formulation that is safe, effective, convenient to use, and not previously
marketed for Appellant’s intended use); Ans. 12).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that “neither Patt nor Diembeck represent analogous art,” because
“[s]imilar to Hittel, neither reference teaches or suggests a topical
composition comprising ivermectin and similar to Manetta and Hittel,
neither teaches a topical composition for use in treating lice” (Appeal Br.
30; Reply Br. 18–19).
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We are not persuaded by Appellant’s contention that one of ordinary
skill in this art would not have been motivated to select shea butter from
Patt’s list of emollients (see Appeal Br. 30–31; Reply Br. 19–20; cf. Ans.
12–13). See Sinclair, 325 U.S. at 335 (“Reading a list and selecting a known
compound to meet known requirements is no more ingenious than selecting
the last piece to put into the last opening in a jig-saw puzzle. It is not
invention.”).
We are also not persuaded by Appellant’s contention that because
Diembeck discloses the use of shea butter in one of twenty example, it fails
to “provide any guidance to select shea oil from the oily substances
disclosed therein or any advantage to be gained by substituting the same for
the fatty substances of Manetta” (Appeal Br. 30–31; see Reply Br. 20). See
Merck & Co. Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed.
Cir. 1989) (“Disclos[ure of] a multitude of effective combinations does not
render any particular formulation less obvious.”). In addition, we note that
Diembeck was not applied in isolation, but, rather, was applied in
combination with Manetta, Hittel, and Patt. Patt discloses the utility of shea
butter as an emollient in topical compositions (see FF 18–19; see also Ans.
13). Diembeck adds to the combination of Manetta, Hittel, and Patt by
suggesting the amount of shea butter to add to a topical composition, i.e. 2%
by weight (see FF 20).
Thus, we find no error in Examiner’s combination of Manetta, Hittel,
Patt, and Diembeck to suggest the composition of Appellant’s claim 3 (see
FF 1–20). For the foregoing reasons, we are not persuaded by Appellant’s
contention that “Patt or Diembeck, alone or in combination, [fails to] remedy
the deficiencies of Manetta and Hittel,” as the combination applies to
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Appellant’s claim 3 (Appeal Br. 30). For the same reasons, we are not
persuaded by Appellant’s contention that Examiner’s rejection is based on
the “improper use of hindsight” (Appeal Br. 31).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claims 1, 22, and 23 under 35 U.S.C. § 103 as
unpatentable over the combination of Manetta and Hittel is affirmed.
Claims 2, 4–10, 21, 26, and 27 are not separately argued and fall with claim
1.
The rejection of claims 1 and 3 under 35 U.S.C. § 103 as unpatentable
over the combination of Manetta, Hittel, Patt, and Diembeck is affirmed.
Claims 2, 4–10, 21–23, 26, and 27 are not separately argued and fall with
claim 1. Claim 25 is not separately argued and falls with claim 3.

OBVIOUSNESS-TYPE DOUBLE PATENTING:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
ANALYSIS
Appellant’s claim 1, reproduced above, is representative.
On this record, Appellant does not contest the rejections of claim 1
under the judicially created doctrine of obviousness-type double patenting
(see Ans. 13–14 (“Appellant presents no arguments with respect to the
rejection of claims 1-10, 21-23, and 25-27 on the ground of nonstatutory
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double patenting as being unpatentable over claims 1, 4-8 and 23-25 of
[Spring ’153] and claims 1, 14-18, 21-25, and 39-41 of [Spring ’595]”)).
Appellant also did not file a terminal disclaimer to moot these rejections.
“If a ground of rejection stated by the examiner is not addressed in the
appellant’s brief, appellant has waived any challenge to that ground of
rejection and the Board may summarily sustain it.” MPEP § 1205.02 (9th
Ed., Rev. 08.2017 (Jan. 2018)).
Accordingly, the obviousness-type double patenting rejections are
summarily affirmed.
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness-type double patenting.
The rejection of claims 1–10, 21–23, and 25–27 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1, 4–8, and 23–25 of Spring ’153 is affirmed.
The rejection of claims 1–10, 21–23, and 25–27 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1, 14–18, 21–25, and 39–41 of Spring ’595 is affirmed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
25 112(b) Indefiniteness 25
1, 2, 4–10,
21–23, 26,
27
103 Manetta, Hittel 1, 2, 4–10,
21–23, 26,
27

1–10, 21–23,
25–27
103 Manetta, Hittel,
Patt, Diembeck
1–10, 21–
23, 25–27

1–10, 21–23,
25–27
Nonstatutory
Double Patenting,
Spring ’153
1–10, 21–
23, 25–27

1–10, 21–23,
25–27
Nonstatutory
Double Patenting,
Spring ’595
1–10, 21–
23, 25–27

Overall
Outcome
1–10, 21–
23, 25–27

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