Ex Parte Precopio

Board of Patent Appeals and Interferences

Mar 3, 2010

10519372 (B.P.A.I. Mar. 3, 2010)

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.
10/519,372 12/23/2004 Michael J. Precopio SU 103 US 4152
7590 03/04/2010
Henry E. Millson, Jr.
675 Golden Hawk Drive
Prescott, AZ 86301-6623
EXAMINER
LEVY, NEIL S
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
03/04/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte MICHAEL J. PRECOPIO
__________

Appeal 2009-009634
Application 10/519,372
Technology Center 1600
__________

Decided: March 4, 2010
__________

Before ERIC GRIMES, FRANCISCO C. PRATS, and STEPHEN WALSH,
Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for the topical treatment of ectoparasites, e.g., lice. The Patent
Examiner rejected some claims as anticipated and all the claims for
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Appeal 2009-009634
Application 10/519,372

2
STATEMENT OF THE CASE
“This invention relates to methods for treating ectoparasite
infestations on mammalian bodies, particularly lice infestations in humans.”
(Spec. 1:24-25.) Claims 1, 3-9, 11, 13, 15, 16, 18, 20-26, 33-36 and 45-63,
which are all the pending claims, are on appeal.
Claims 1 and 45 are representative. Claim 1 defines a method for
treating ectoparasites. Claim 45 defines a method for treating lice. The
method in claim 45 differs from the method in claim 1 by replacing nearly
all references to the target “ectoparasites” and “eggs” with “lice” and “nits,”
respectively. Claims 1 and 45, using brackets to show where claim 45
differs, read as follows:
1 [45]. A method for the topical treatment of ectoparasites [lice], their
nymphs, and their eggs [nits], on mammalian skin and hair comprising
the steps of:

A) applying a water soluble or water-dispersible, substantially air
impermeable, pharmacologically acceptable barrier composition
containing at least one pesticidally-active monohydric aralkyl alcohol
to areas of mammal skin and hair infected with ectoparasites [lice]
wherein
a) the composition contains a quantity in the range of from
about 1 to about 50% by weight of the at least one monohydric aralkyl
alcohol sufficient to provide pesticidal activity against the
ectoparasites, their nymphs, and their eggs,
b) the composition is formulated so that when applied to the
ectoparasites [lice], the composition prevents them from obtaining air
through their breathing apparatuses,
c) the composition is applied to the infected areas in a quantity
sufficient to completely saturate both the hair and the skin in the
infected areas,
d) the composition can be readily washed out of the infected
areas by rinsing with water, and
e) the composition is free from any effective pesticidally active
Appeal 2009-009634
Application 10/519,372

3
compounds other than the at least one pesticidally-active monohydric
aralkyl alcohol, and

B) leaving the composition in contact with the skin and hair in the
infected area until at least most of the ectoparasites [lice], nymphs and
eggs [nits] have been killed; and

C) removing the composition, the dead ectoparasites [lice], and dead
nymphs from the skin and hair with water or other aqueous based
liquid.

The Examiner relied on the following evidence:
Lover et al. US 4,368,207 Jan. 11, 1983
Cardin et al. US 5,288,483 Feb. 22, 1994
Pearlman US 6,303,581 Oct. 16, 2001
Precopio US 6,793,931 Sep. 21, 2004
Bessette US 6,974,584 Dec. 13, 2005
Precopio US 7,292,342 Nov. 13, 2007
Gans et al US 2003/0040504 Feb. 27, 2003
Precopio US SN# 10/382,188 Mar. 04, 2003

The Examiner rejected the claims as follows:
• claims 45-48, 50-53 and 55-63 under 35 U.S.C. § 102(b) as
anticipated by Gans;1
• claims 1, 3-9, 11, 13, 15, 16, 18, 20-26, 33-36 and 45-63 under
35 U.S.C. § 103(a) as unpatentable over the combined teachings of Lover,
Bessette, Cardin and Pearlman;
• claims 1, 3-5, 8, 9, 13, 18, 20 and 22-26 on the ground of
nonstatutory obviousness-type double patenting over claims 28, 29 and 31-
38 of Precopio ‘931;

1 The Final Rejection included claim 54 in this group. (Fin. Rej. 2; App. Br.
15.) The Examiner’s Answer does not (Ans. 4); we conclude the Examiner
withdrew the anticipation rejection of claim 54.
Appeal 2009-009634
Application 10/519,372

4
• claims 1, 3-6, 8, 9, 13, 15, 16, 18, 20, 22-26 and 33 provisionally on
the ground nonstatutory obviousness-type double patenting over pending
claims 33, 35-38, 44-46, 49-51, 65-67 and 69-81 of Precopio ‘188; and
• claims 1, 3-5, 8, 9, 11, 13, 15, 16, 18 and 20 on the ground of
nonstatutory obviousness-type double patenting over claims 1-3, 5-13, 15
and 16 of Precopio ‘342.

ANTICIPATION
The Issue
The Examiner’s position is that Gans described the claimed method
using benzyl alcohol as the sole active ingredient at a concentration of from
0.5-20%, applied in gel or shampoo, left on for up to 20 minutes and rinsed
off with water. (Fin. Rej. 2.) “Although GANS provide[d] no explicit
instruction to completely saturate the hair & skin of affected areas, the intent
to achieve 100% kill with 1 application is clearly the impetus to sufficiently
cover [the hair and skin].” (Ans. 5.)
Appellant contends that Gans paragraph [0021] disclosed benzyl
alcohol as a second active ingredient; that Gans did not disclose air-
impermeable compositions; that Gans paragraph [0014] required four active
ingredients to kill eggs and lice; that the Examiner cited Gans Examples VI
and XII as air impermeable compositions but that those examples used
active ingredients in addition to benzyl alcohol; and that there is no basis for
the Examiner’s assumption that Gans disclosed air impermeable
compositions. (App. Br. 16-17.) Appellant argues that in contrast to the
about 20 minute time Gans disclosed for benzyl alcohol compositions to kill
Appeal 2009-009634
Application 10/519,372

5
ectoparasites, only 2-10 minutes are needed for suffocating ectoparasites
with Appellant’s method. (Id. at 17.)
The issue with respect to this rejection is whether the evidence
supports the Examiner’s finding that Gans described the method defined in
claim 45.

Findings of Fact
1. Gans described compositions and methods for killing mammalian
ectoparasites and eggs. (Gans, Abstract.)
2. Gans described a preferred composition in which benzyl alcohol was
the sole active ingredient, in an amount “from about 0.50% w/w to
about 20% w/w,” and in additional preferred embodiments “from
about 3% w/w to about 6% w/w, preferably 4.5% w/w.” (Gans,
10:[0107]-[0108].)
3. Gans taught topical application to the hair and scalp to treat head lice.
(Gans, 10:[0110].)
4. Gans taught carriers including a gel, a thickening agent such as
polyethylene glycol, and others. (Id.)
5. “A preferred embodiment of the [Gans] invention comprises applying
a composition to mammalian ectoparasites on mammals for a short
time (for example, without limitation, about 5 to about 30 minutes),
and then rinsing.” (Gans, 11:[0113].)
6. “In preferred embodiments, the compositions and methods disclosed
herein are used on humans to control human ectoparasites and in
particular, human lice.” (Gans, 4:[0051].)
Appeal 2009-009634
Application 10/519,372

6
7. Gans disclosed using a single active ingredient in combination with an
adjuvant:
An adjuvant is an ingredient that assists in the killing event in some
way. Examples of adjuvants include, for example, certain essential
oils . . . that do not substantially kill ectoparasites on their own but
which in combination with an active ingredient, assists the killing
effect of the active ingredient, such as, for example, by maintaining
the active ingredient in place on the area to be treated.

(Gans, 9:[0099].)
8. Appellant’s Specification discloses that the compositions employed in
the methods of the invention kill the ectoparasites “by a combination
of suffocation and pesticidal, e.g, pediculicidal, activity of the aralkyl
alcohols where the compositions are air–impermeable and these are
the only mechanisms of action . . . . [T]he ectoparasite eggs are also
killed by the insecticidal activity of the aralkyl alcohols.” (Spec. 9:6-
10.)
9. “By substantially air-impermeable is meant that the composition does
not contain sufficient air nor does it permit air to penetrate the
composition in a quantity that would prevent the composition from
suffocating the ectoparasites.” (Id. at 8:8-10.)

Principles of Law
To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or
inherently. Anticipation is an issue of fact, and the question
whether a claim limitation is inherent in a prior art reference is
a factual issue.

In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997) (citations omitted).
Appeal 2009-009634
Application 10/519,372

7
The test for anticipation “is not an ‘ipsissimis verbis’ test.” In re Bond,
910 F.2d 831, 832 (Fed. Cir. 1990). “An anticipation reference, however,
need not duplicate word for word what is in the claims. Anticipation can
occur when a claimed limitation is ‘inherent’ or otherwise implicit in the
relevant reference.” Standard Havens Prods., Inc. v. Gecor Indus., Inc.,
953 F.2d 1360, 1369 (Fed.Cir.1991). “[I]n considering the disclosure of a
reference, it is proper to take into account not only specific teachings of the
reference but also the inferences which one skilled in the art would
reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826-
27 (CCPA 1968) (affirming anticipation finding of implicit fact).
“The anticipation analysis asks solely whether the prior art reference
discloses and enables the claimed invention, and not how the prior art
characterizes that disclosure or whether alternatives are also disclosed.”
Hewlett-Packard Co. v. Mustek Sys., Inc., 340 F.3d 1314, 1324 n.6 (Fed. Cir.
2003), quoted in Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1376
(Fed. Cir. 2005) (affirming anticipation where the prior art’s “disclosed
range of concentration also does not exactly correspond to [the] claimed
range,” 432 F.3d at 1377).

Analysis
Claim 45
We agree with the Examiner that Gans described the invention
defined in Appellant’s claim 45. Appellant’s arguments about Gans
teaching multiple active ingredients are unpersuasive because Gans
explicitly described an embodiment in which benzyl alcohol was the only
active ingredient (FF2). Moreover, the Examiner emphasized the clarity of
Appeal 2009-009634
Application 10/519,372

8
Gans’ disclosure on this point by pointing to Gans’ claim 12, which
explicitly recited benzyl alcohol as the sole active ingredient. (Ans. 4.)
According to Appellant, Gans’ composition containing only benzyl
alcohol as the sole active ingredient could not have been air impermeable
because Gans ¶[0107] “gives a time of about 20 minutes . . . to kill
ectoparasites.” (App. Br. 17.) The evidence does not support Appellant’s
reading that Gans required 20 minutes. Gans ¶[0107] states: “Benzyl
alcohol, for example, is effective at killing ectoparasites within about 20
minutes, or preferably less time, of the initial application” (emphasis added).
Thus, Gans did not teach that 20 minutes was required. The Examiner also
cites Gans’ disclosure of a preferred embodiment applying the composition
“for a short time (for example, without limitation, about 5 to about 30
minutes), and then rinsing. The ectoparasites are killed or stunned and the
live and dead ectoparasites and their eggs are effectively removed from the
mammal.” (Gans 11:[0113].)
Appellant contends that, in contrast to Gans, “time frames of only 2-
10 minutes are needed for suffocating the ectoparasites” in the claimed
method, to kill rates of “greater than 99%,” “94.9%,” and “93.1%.” (App.
Br. at 17-18, citing Spec. at 5, and Examples 15 and 17.) Appellant’s
Specification discloses:
contact time is somewhat dependent on the particular ectoparasite
being treated, but it has now been discovered that in general the
contact time can be for a period of at least 2 minutes, preferably at
least 3 minutes, and more preferably at least 5 minutes. Periods of
from 2 to 10 minutes can be used, preferably from 3 to 10 minutes,
e.g. from 3 to 8 or 9 minutes. It has now been found that contact
times of greater than 9 or 10 minutes are unnecessary and do not
provide any additional benefits, particularly where the composition is
Appeal 2009-009634
Application 10/519,372

9
air-impermeable, although of course longer contact times can be used
if desired.

(Spec. at 5:18-6:2.) The Specification does not persuade us that claim 45
can be distinguished from Gans’ explicit disclosure of an about 5 minute
treatment time. Claim 45 does not recite time in minutes; instead, its
temporal limitation is functional: “until at least most of the ectoparasites,
nymphs and eggs have been killed.” The Examiner’s evidence was
sufficient to shift the burden to Appellant to show that Gans’ method did not
perform that function. See Schrieber, 128 F.3d at 1478. Appellant argues
that Example 15 shows “a kill rate greater than 99% was achieved in 10
minutes,” citing Spec. p. 26, ll. 18-20. (App. Br. 17.) However, the text
makes it clear that the greater than 99% kill rate was determined “[a]t the
Day 8 post treatment,” (Spec. 26:18), i.e., after two 10-minute treatments
separated by a week. Cf. Spec. 26:3-4 (“At the day 8 pre-treatment
evaluation, subjects in both the 10-minute and 30-minute application
treatment groups had lice and nits present.”). We find that Example 15 does
not show that claim 45 is distinguished from Gans’ about 5 minute method.
Example 17 is similarly unpersuasive because it discloses a 10 minute in
vitro anti-nit procedure, which is not comparable to Gans’ about 5 minute in
vivo method.
Appellant disputes the Examiner’s finding that Gans disclosed
applying the composition to the infected areas in “a quantity sufficient to
completely saturate both the hair and the skin in the infected areas,” as
required by claim 45(A)(c). (App. Br. 18.) We agree that Gans did not
explicitly use those terms. However, we agree with the Examiner that in
context, that is how those in this art would understand Gans’ disclosure.
Appeal 2009-009634
Application 10/519,372

10
(See Ans. 5.) The Examiner cited, e.g., Gans at 10:[0110], which disclosed
topical treatment of the hair and scalp, and formulating the active ingredient
as “a cleanser (preferably, a shampoo).” (Id.) Gans did not teach applying
shampoo to only portions of the hair and scalp, but instead taught applying it
to hair and scalp. Appellant has not provided a reasonable basis to find that
a skilled artisan would understand Gans meant to apply the shampoo only
partly. We think the Examiner correctly explained what Gans’ disclosure
meant to those in this art. See Preda, 401 F.2d at 826-27.
Appellant refers to the Declaration under 37 CFR 1.132 dated June 4,
2007 (App. Br. 18.), but the Declaration does not address whether Gans
disclosed applying a saturating quantity. The Declaration compares two
studies, or treatment protocols. In STUDY 1, a composition was applied to
the hair and skin of the subjects and then rinsed off, resulting in a kill rate of
89%. (Decl. 2-3.) In STUDY 2, “the quantity of the composition was
adjusted for each subject so that complete saturation of the entire length of
each subjects hair was obtained,” resulting in a kill rate of greater than 99%.
(Decl. 3.) According to the Declaration, “[t]he results obtained in Study 1
were found to have resulted from incomplete saturation of the entire length
of the long hairs in the subject population of that study.” (Id.) According to
the Declaration, the finding “that the entire length of the subject’s hair must
be completely saturated with the compositions of the invention to obtain
very high treatment success and kill rates, was unexpected and unobvious.”
(Id.) The Declaration does not address whether Gans did or did not
implicitly disclose using saturating quantities, nor does it take a position on
how a person of skill in this art would have understood Gans.
Appeal 2009-009634
Application 10/519,372

11
Claim 48
Appellant argues that Gans’ disclosure of repeated administrations in
¶[0084] is “essentially meaningless with respect to any particular
composition having the ability to ‘kill human ectoparasite eggs.’” (App. Br.
19.) Appellant bases the argument on Gans’ statement “it is believed that
these compositions and/or methods will also kill human ectoparasite eggs.”
(Id.) Gans expressly disclosed killing mammalian ectoparasite eggs, and
that human head lice were targets. See, e.g., Gans 1:[0012], claim 12 and
claim 50. Appellant’s emphasis on the “it is believed” phrase is
unpersuasive when Gans’ disclosure is considered as a whole.
Claims 55-59
Appellant argues that Gans did not disclose the recited ranges for
benzyl alcohol (App. Br. 19.) We disagree. The ranges recited in these
claims are 1-20%, 2-20%, 2-9%, 3-7%, and 4-6%, respectively. Gans taught
benzyl alcohol in an amount from about 0.50% to about 20%, and in
preferred embodiments “from about 3% w/w to about 6% w/w, preferably
4.5% w/w”. (FF2.) Every percentage that Appellant recites for use in the
method includes the 4.5% species expressly disclosed by Gans. Gans
therefore anticipates the recited ranges. See Titanium Metals Corp. of
America v. Banner, 778 F.2d 775, 782 (Fed. Cir. 1985) (“[W]hen, as by a
recitation of ranges or otherwise, a claim covers several compositions, the
claim is ‘anticipated’ if one of them is in the prior art.”).
Claim 62
Appellant argues that Gans did not disclose contact for “at least”
about 2 minutes; that Gans did not disclose treating head lice; and that Gans
did not disclose treating the skin and hair of a human being. (App. Br. 19.)
Appeal 2009-009634
Application 10/519,372

12
We disagree. Gans’ 5 minute treatment was “at least” about 2 minutes
(FF5); Gans taught treating head lice by applying the composition to hair
and scalp (FF3); and Gans taught treating human beings (FF6).
Claims 46, 47, 50-53, 60, 61 and 63 have not been argued separately
and therefore fall with representative claim 45. 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS
The Issue
The Examiner’s position is that Lover taught the use of phenyl ethyl
and benzyl alcohols as single active agents at concentrations of 10-40% in
gels or shampoos to kill lice and their eggs, but that Lover did not discuss
suffocation, rinsing or saturating. (Ans. 7.) The Examiner found that
Bessette disclosed benzyl alcohol in gel and shampoo carriers to control
human head and body lice, resulting in 100% mortality. (Id.) The Examiner
found that Bessette’s “application thus must include thorough saturation of
hair and scalp, since it must be applied in an amount sufficient to effect the
desired action.” (Id.) According to the Examiner, Cardin taught using
compounds within Appellant’s formula I, including phenyl alkanols, phenyl
propanol and phenyl ethyl alcohol, in lotions worked into the hair and scalp,
left on for 6-10 minutes and then rinsed off. (Id. at 8.) The Examiner found
that Cardin’s teaching of working the compositions into the scalp and hair
met the “sufficient to saturate” requirement of the claims. (Fin. Rej. 3.)
Caardin also taught formulating the compositions with Appellant’s claimed
film formers, surfactants, and gelling or thickening agents. (Ans. 8.) The
Examiner found that Pearlman treated human ectoparasites with barrier
compositions that suffocate lice. (Id.) Pearlman taught using surfactants
Appeal 2009-009634
Application 10/519,372

13
and adjuvants, thickeners and gums. (Id. at 9.) Pearlman used phenyl
alkanols as solvents. (Id.)
The Examiner concluded that it would have been obvious to use the
compositions and methods disclosed in Lover, Bessette, Cardin and
Pearlman to increase pesticidal efficacy without irritation or side effects, to
increase stability, dispersibility, and reduce toxicity to the person infected.
(Id.) According to the Examiner, “the artisan would readily select the
instant aralkyl alcohol, as benzyl or phenyl ethyl alcohol shown effective by
Lover [and] Bessette to provide a high rate of kill of both lice [and] their ova
when applied to hair and scalp at 1-20% of a carrier composition of
shampoo, film or gel, to permit retention for a 20 minute period before being
washed off, as shown by Cardin also using the instant formula I aralkyl
alcohol to kill lice.” (Id.) Whether Cardin’s phenyl ethanol or Lover or
Bessette’s benzyl alcohol was used, Pearlman taught that lice treatment
consisted of thorough wetting of hair and scalp, leaving in place for a few
minutes, rinsing off, and repeating if needed. (Id.)
Appellant contends that Lover’s results show that benzyl alcohol was
not effective at killing lice, and that Lover teaches away from using either
benzyl alcohol or phenyl ethanol. (App. Br. 20-21 and 24.) Appellant
contends that Bessette disclosed that only benzyl alcohol in combination
with pyrethrins gave a “very good kill.” (Id. at 27.) Appellant contends that
Cardin disclosed alkanols only as synergizers for pediculicide ammonium or
amine compounds, i.e., not as the claimed sole active agent. (Id. at 29.)
According to Appellant, Cardin’s disclosure of working the composition into
the scalp is therefore not relevant to the claimed method. (Id.) Further,
according to Appellant, the Declaration “shows the unexpected criticality of
Appeal 2009-009634
Application 10/519,372

14
making certain even the longest strands of hair are completely saturated with
the present compositions, which is clearly not disclosed by Cardin.” (Id. at
30.) Appellant contends that Pearlman “is directed to driable pediculostatic
agents that elicit an ‘immersion reflex’ in lice to immobilize them,” does not
disclose monohydric aralkyl alcohols, and “contain[s] no disclosures
relevant to the presently claimed invention.” (Id. at 32.) According to
Appellant, the rejection combines the references without a teaching or
suggestion to do so in the references, and is “a hindsight rejection using the
present invention as a template.” (Id.) Further, Appellant contends that the
rejection does not account for all the features of the claims. (Id. at 34-35.)
The issues with respect to this rejection are:
whether the explanation of the rejection accounted for all the
limitations of the claims; and
whether the Examiner provided a properly reasoned basis for
combining the teachings of the references.

Findings of Fact
Lover
10. Lover disclosed that phenyl ethyl alcohol and benzyl alcohol kill
ectoparasites and their eggs, including lice and mites, as evidenced by
the results of two minute immersion tests. (Lover, cols. 3 and 4.)
11. Lover’s Table I shows lice killing ratings (i.e., percent mortality) for
various solutions including benzyl alcohol and 2-phenylethanol.
100% benzyl alcohol had a rating of 90, 25% benzyl alcohol had a
rating of 0, and 15% benzyl alcohol in 25% isopropanol had a rating
Appeal 2009-009634
Application 10/519,372

15
of 5. 100% 2-phenylethanol had a rating of 100, and 15% 2-
phenylethanol in 25% isopropanol had a rating of 80. (Id. at col. 3.)
12. We find that isopropanol is an active lice killing agent because
Lover’s Table I disclosed that 100% isopropanol had a kill rating of
65. (Id.)
13. Lover’s Table II shows lice egg killing ratings (i.e., percent mortality)
for various solutions including benzyl alcohol and 2-phenylethanol.
100% benzyl alcohol had a rating of 100, 25% benzyl alcohol had a
rating of 100, and 15% benzyl alcohol in 25% isopropanol had a
rating of 29. 100% 2-phenylethanol had a rating of 100, 25% 2-
phenylethanol had a rating of 100, and 15% 2-phenylethanol in 25%
isopropanol had a rating of 34. (Id. at col. 4.)
14. Lover’s Table III shows mite killing ratings for various alcohol
solutions. 100% benzyl alcohol and 100% 2-phenylethanol had the
same rating: 100. (Id. at col. 4.)
15. Lover taught that the minimum concentration required for an effective
toxic amount varied depending on the alcohol and carrier used, so that
“in one case a 10% concentration may suffice, while in other cases,
concentrations as high as 30 to 40% may be required to obtain an
effective toxic dose.” (Id. at col. 2, ll. 39-48.)
16. Lover taught end use formulations including gel and shampoo. (Id. at
col. 5.)
Bessette
17. Bessette disclosed using a plant essential oil to control the human
body louse. (Bessette, col. 2, ll. 50-57.)
Appeal 2009-009634
Application 10/519,372

16
18. Bessette taught that benzyl alcohol was a plant essential oil that could
be used. (Id. at col. 3, ll. 22-23.)
19. According to Bessette, “[u]se of pesticidal compositions of the present
invention generally results in 100% mortality on contact . . . .
employed as pesticidal agents in uses as . . . shampoos, hair gels, body
cremes, lotions, and other on-skin application for the treatment of
head lice, body lice, and pubic lice.” (Id. at col. 3, ll. 61-67.)
20. Bessette disclosed applying the compound “in an amount sufficient to
effect the desired action.” (Id. at col. 6, ll. 32-37.)
21. The Examiner found that Bessette’s application “must include
thorough saturation of hair and scalp, since it must be applied in an
amount sufficient to effect the desired action.” (Ans. 7.)
22. Bessette taught that in general “the effective dosage . . . is of the order
of 0.001 to 5.0% based on total weight of the formulation, though
under some circumstances the effective concentrations will be as little
as 0.0001% or as much as 20%, on the same basis.” (Id. at col. 6, ll.
35-52.)
Cardin
23. Cardin taught anti-lice compositions comprising “quaternary
ammonium salts, fatty amines, and mixtures thereof with low levels of
specific alkanols.” (Cardin, col. 1, ll. 10-12.)
24. Cardin’s alkanols included phenyl C2-C6 alkanols such as phenyl
ethanol. (Id. at col. 3, ll. 33-47.)
25. Cardin taught using the alkanols at about 0.5% to about 5%. (Id. at
col. 5, l. 64 – col. 6, l. 5.)
Appeal 2009-009634
Application 10/519,372

17
26. Cardin taught using thickening agents, gums, and polymers. (Id. at
col. 12, ll. 54-68.)
27. Cardin taught applying the composition to wet hair, “(b) working said
composition through the hair and scalp; (c) leaving the composition
on the hair and scalp for about 6-10 minutes; and (d) rinsing the
composition from the hair.” (Id. at col. 12, ll. 22-33.)
Pearlman
28. Pearlman disclosed a method of treating lice infestations by applying
“an effective amount of a driable pediculostatic agent for a time
sufficient to immobilize the lice, drying the agent onto the application
site and removing the dried agent, thereby removing the lice and nits.”
(Pearlman, Abstract.)
29. Pearlman taught:
A pediculostatic agent is one that elicits the “immersion reflex” in
lice. . . . During submersion, the spiracles and tracheoles, through
which lice breathe, become blocked by water. As the lice become
anoxic, they rapidly switch to a state of profound suspended
animation, decreasing their need for oxygen . . . . If the reflex
continues too long, however, the lice eventually run completely out of
oxygen and die from anoxia.

(Id. at col. 5, ll. 1-16.)
30. Pearlman’s “driable pediculostatic agent is one that triggers the
immersion reflex when wet, and that maintains the lice in the
immersion reflex when thereafter dried in situ.” (Id. at col. 5, ll. 18-
20.)
31. Pearlman disclosed that “[f]or most driable pediculostatic agents, at
least some of the lice can be killed by leaving the dried agent on the
lice and hair for at least about 8 hours.” (Id. at col. 8, ll. 8-10.)
Appeal 2009-009634
Application 10/519,372

18
32. Pearlman taught using surfactants (id. at col. 11, ll. 51-57) and
solvents to hasten the drying time such as phenyl C2-C6 alkanols (id.
at col. 13, ll. 28-32).
33. Pearlman taught using thickeners. (Id. at col. 13, ll. 56-60.)

Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[I]f a technique
has been used to improve one device, and a person of ordinary skill in the art
would recognize that it would improve similar devices in the same way,
using the technique is obvious unless its actual application is beyond his or
her skill.” Id. at 417. The obviousness “analysis need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” Id. at 418.
“In considering [prior art] disclosures, it is proper to take into account
not only specific teachings of the references but also the inferences which
one skilled in the art would reasonably be expected to draw therefrom.” In
re Hoeschele, 406 F.2d 1403, 1406-07 (CCPA 1969) (affirming findings and
conclusion of obviousness) (citations omitted). Each prior art reference
“must be read, not in isolation, but for what it fairly teaches in combination
with the prior art as a whole.” In re Merck & Co., Inc., 800 F.2d 1091, 1097
(Fed. Cir. 1986) (citation omitted). “Obviousness does not require absolute
predictability of success. . . . [A]ll that is required is a reasonable
Appeal 2009-009634
Application 10/519,372

19
expectation of success.” In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir.
1988).
“[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991)
(“Mere recognition of latent properties in the prior art does not render
nonobvious an otherwise known invention.”).

Analysis
Appellant argues that Lover does not teach or suggest the monohydric
aralkyl concentration range of the claims. (App. Br. 20-22.) The Examiner
found that Lover tested alcohols and the results showed that compositions
containing 10-40% alcohol were pesticidally active. (Ans. 7.) However,
Lover did not show that a composition of a monohydric aralkyl alcohol, as
the only active compound, was active in killing both ectoparasites and their
eggs, in that range. (FF11-14.) While we agree that Lover provided general
guidance that effective concentrations would vary according to the alcohol
chosen, the tabular data for benzyl alcohol or phenylethanol (FF11-14), does
not show that either would be effective in the general 10-40% range (FF15).
The evidence is insufficient to support a finding that Lover disclosed
effective monohydric aralkyl formulations in the claimed 1-50% range.
The Examiner found Bessette disclosed effective benzyl alcohol
formulations of 0.001-5% and up to 20% (Ans. 7.) The evidence supports
that finding. (FF22.) Appellant argues that the only benzyl alcohol
formulation Bessette tested (contact toxicity) that showed a “kill rating” is
excluded by Appellant’s claims because it also contained pyrethrins. (App.
Appeal 2009-009634
Application 10/519,372

20
Br. 27.) This argument is unpersuasive because Bessette explicitly taught
formulating up to 20% of an active agent alone, such as benzyl alcohol, to
kill ectoparasites, including lice. We conclude that Bessette’s disclosure
supplemented Lover’s disclosure, and rendered the claimed range obvious at
the time of Appellant’s invention.
The Examiner found that Cardin disclosed licicidal formulations of
phenyl alkanols of Appellant’s formula I, free of conventional pesticides.
(Ans. 8.) We agree with Appellant that the evidence does not support that
finding because Cardin’s formulations included quaternary ammonium salts
(FF23), which had pediculicidal activity. However, we find Cardin pertinent
to the subject matter of Lover, Bessette and Pearlman, and that Cardin is
analogous art. We agree with the Examiner that Cardin’s teachings of film
formers, surfactants, gelling and thickening agents, gums and polymers, and
methods of working the licicidal composition into the hair would have been
suggestive to the ordinary artisan.
The Examiner found that “[r]egardless of the particular agent used . . .
treatment for lice is shown by Pearlman to consist of application to the hair
& scalp of a composition by thorough wetting of hair & scalp, leaving in
place for a few minutes, rinsing off & repeating if needed.” (Ans. 9.)
Appellant argues that Pearlman contains “no disclosures relevant to the
presently claimed invention,” and cites seven asserted elements of the
claims. (App. Br. 32.) We agree with the Examiner that Pearlman is
analogous art. However, the evidence does not support the Examiner’s
finding that Pearlman taught leaving the composition in place for only a few
minutes (the “short time” in Appellant’s list of items). (FF31.) Although
“short time” is not a feature of the independent claims, pediculicide contact
Appeal 2009-009634
Application 10/519,372

21
periods up to 10 minutes recited in dependent claims were known in the art
(e.g. FF27) and would have been obvious.
We also agree with the Examiner that Pearlman’s explanation of
suffocating compositions shows that suffocation would have been the
expected result of the known benzyl alcohol formulations and treatment
methods suggested by Bessette in combination with the other references.
See FF29.
Appellant argues that “the Examiner does not explain why the
disclosed processes in the prior art would inherently (necessarily) yield the
same product used in the present method claims.” (App. Br. 33.) However,
Bessette taught using benzyl alcohol alone, and the evidence supports the
Examiner’s view that Appellant’s claims combine the use of known
components for their known properties. Combining the known formulations
and known methods was within the level of skill in the art, and Appellant
has not shown that the ordinary artisan would not have had a reasonable
expectation of success in doing so.
Appellant argues that data shows the products used in the claimed
method exhibit properties “which are not exhibited by those prepared in
accordance with any process disclosed in the references.” (App. Br. 33-34,
referencing Spec. Examples 1-17.) None of the examples show comparative
data against the closest prior art. None of the examples show that air
impermeability or suffocating ability could be a property of Appellant’s 1-
50% benzyl alcohol formulation but not a property of Bessette’s up to 20%
benzyl alcohol formulation.
Appeal 2009-009634
Application 10/519,372

22
Claims 3-9, 11, 13, 15, 16, 18, 20-26, 33-36 and 45-63 have not been
separately argued and therefore fall with representative claim 1. 37 C.F.R.
§ 41.37(c)(1)(vii).

NONSTATUTORY OBVIOUSNESS-TYPE DOUBLE PATENTING
Principles of Law
The analysis employed in an obviousness-type double patenting
rejection is similar to the analysis used in a 35 U.S.C. § 103 obviousness
determination. In re Braat, 937 F.2d 589, 592-93 (Fed. Cir. 1991). A
generic invention is anticipated by a species covered by an earlier claim;
absent a terminal disclaimer, the species claims preclude issuance of a
generic claim. In re Goodman, 11 F.3d 1046, 1053 (Fed. Cir. 1993).

Issue
The Examiner concluded that the claims on appeal are not patentably
distinct from certain patented or copending claims, and required Appellant to
file terminal disclaimers limiting any patent term for the appealed claims by
the terms of the two cited patents and the cited application.

Analysis Involving The ‘931 and ‘342 Patent Claims
Appellant contends that the rejections over the ‘931 patent and the
‘342 patent should be reversed because the patented claims do not contain
these limitations of the claims on appeal, and nothing in the patented claims
renders these limitations obvious:
1) effectiveness against nymphs and eggs as well as the ectoparasites
themselves;
Appeal 2009-009634
Application 10/519,372

23
2) the requirement of complete saturation of the hair and skin;
3) leaving the composition in contact with the infected skin and hair
until most of the nymphs and eggs have been killed; and
4) topical treatment of ectoparasites, not just lice. (App. Br. 37-38;
39-40.) We address these points in turn.
1) The claims on appeal define a method “for the topical treatment
of ectoparasites, their nymphs, and their eggs” (claim 1), or “for the topical
treatment of lice, their nymphs, and their nits” (claim 45). Claim 28 in the
‘931 patent defines a method “for the topical treatment of lice.” Claim 1 in
the ‘342 patent defines a method “for the topical treatment of lice
infestations.” The generic aspect of the appealed claims is anticipated by the
species “lice” in the issued claims, and the requirements for terminal
disclaimer were proper in this regard. See Goodman, 11 F.3d at 1053.
Appellant’s first point is therefore unpersuasive.
2) The claims on appeal define a method “wherein . . . c) the
composition is applied to the infected areas in a quantity sufficient to
completely saturate both the hair and the skin in the infected areas.” Claim
28 in the ‘931 patent defines a method comprising “applying [a composition]
to the skin and hair containing lice.” Claim 1 in the ‘342 patent defines a
method comprising “applying [a composition] to the skin and hair
containing lice.” While neither set of patent claims recites “complete
saturation” of hair and skin, we construe those claims to mean what they
say: apply the composition to the hair and the skin. We agree with the
Examiner that a person of ordinary skill would understand that to mean
covering the hair and skin completely. It is permissible to take into account
the inferences a person of ordinary skill in the art would employ. See KSR,
Appeal 2009-009634
Application 10/519,372

24
550 U.S. at 418; Hoeschele, 406 F.2d at 1406-07. Appellant’s second point
is unpersuasive.
3) The claims on appeal define a method comprising “B) leaving
the composition in contact with the skin and hair in the infected area until at
least most of the ectoparasites, nymphs and eggs have been killed” (claim 1)
or “the lice, nymphs and nits have been killed” (claim 45). Claim 28 of the
‘931 patent defines a method comprising “leaving the composition in contact
with the skin and hair for at least 10 minutes until the lice have been killed
by suffocation.” Claim 1 of the ‘342 patent defines a method comprising
“leaving the composition in contact with the skin and hair until the lice have
been killed by suffocation.” Appellant’s third point is therefore
unpersuasive.
4) The generic aspect (“ectoparasites”) of the appealed claims is
anticipated by the species “lice” in the issued claims, and the requirements
for terminal disclaimer were proper in this regard. See Goodman, 11 F.3d at
1053. Appellant’s fourth point is therefore unpersuasive.

Analysis Involving The Pending ‘188 Application Claims
Appellant contends that the provisional rejection over the copending
application ‘188 claims should be reversed because the copending claims do
not contain these limitations of the claims on appeal:
1) the requirement of complete saturation of the hair and skin; and
2) topical treatment of ectoparasites, not just lice. (App. Br. 38-39.)
1) The claims on appeal define a method “wherein . . . c) the
composition is applied to the infected areas in a quantity sufficient to
completely saturate both the hair and the skin in the infected areas.” Claim
Appeal 2009-009634
Application 10/519,372

25
33 in copending application ‘188 defines a method comprising “A) applying
[a composition] to animal skin and hair containing ectoparasites and their
eggs.” While the copending application claims do not recite “complete
saturation” of hair and skin, we construe the claims to mean what they say:
apply the composition to skin and hair. The copending claims require the
composition to be left on until most of the ectoparasites have been killed by
suffocation. We think that a person of ordinary skill would understand the
claim to mean applying enough composition to achieve suffocation, i.e.,
covering the hair and skin completely. It is permissible to take into account
the inferences a person of ordinary skill in the art would employ. See KSR,
550 U.S. at 418; Hoeschele, 406 F.2d at 1406-07. Appellant’s first point is
unpersuasive.
2) Claim 33 in the copending application defines a method “for
the topical treatment of ectoparasites and their eggs . . . wherein the
ectoparasites are lice and/or mites.” We cannot agree with Appellant’s
argument that the copending claims do not contain the “ectoparasites”
limitation. Appellant’s second point is therefore unpersuasive.

SUMMARY
We affirm the rejection of claims 45-48, 50-53 and 55-63 under
35 U.S.C. § 102(b) as anticipated by Gans;
We affirm the rejection of claims 1, 3-9, 11, 13, 15, 16, 18, 20-26, 33-
36 and 45-63 under 35 U.S.C. § 103(a) as unpatentable over the combined
teachings of Lover, Bessette, Cardin and Pearlman;
Appeal 2009-009634
Application 10/519,372

26
We affirm the rejection of claims 1, 3-5, 8, 9, 13, 18, 20 and 22-26 on
the ground of nonstatutory obviousness-type double patenting over claims
28, 29 and 31-38 of Precopio ‘931;
We affirm the provisional rejection of claims 1, 3-6, 8, 9, 13, 15, 16,
18, 20, 22-26 and 33 on the ground of nonstatutory obviousness-type double
patenting over pending claims 33, 35-38, 44-46, 49-51, 65-67 and 69-81 of
Precopio ‘188; and
We affirm the rejection of claims 1, 3-5, 8, 9, 11, 13, 15, 16, 18 and
20 on the ground of nonstatutory obviousness-type double patenting over
claims 1-3, 5-13, 15 and 16 of Precopio ‘342.

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
lp

HENRY E. MILLSON, JR.
675 GOLDEN HAWK DRIVE
PRESCOTT AZ 86301-6623