ARBOR PHARMACEUTICALS, LLC

Patent Trials and Appeals Board

Jul 8, 2020

15408924 - (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.
15/408,924 01/18/2017 Nicholas Spring 18873.105268 3916
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 2019-005431
Application 15/408,924
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 21–30, 32–38 and 40–45 (Appeal Br. 5; see also
Office Act.3 3). 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 25, 2019 Appeal Brief (Appeal Br.)
3). Appellant’s Appeal Brief is not paginated, therefore, all page numbers
refer to the Appeal Brief as if it were numbered consecutively beginning
with the first page.
2 This Appeal is related to Appeal 2020-000846 (Application 14/572,664)
(see Appeal Br. 4).
3 Examiner’s June 26, 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 21 and 30 are reproduced
below:
21. A method for the treatment or prophylaxis of a lice, the
method comprising:
(a) applying a topical pediculicidal formulation to an area
infested with lice on a human,
wherein the topical pediculicidal formulation comprises
about 0.1 % to about 2.0% by weight ivermectin,
a solubilizer,
weight olive oil,
a non-ionic surfactant paragraphs, and
about 30% to 40% by weight water,
and
(b) maintaining the topical pediculicidal formulation on the area
to provide treated lice wherein the area is the hair or scalp and
the treated lice have a faster mortality response than lice treated
with unformulated 0.5% ivermectin.
(Appeal Br. 30.)5
30. The method of claim 1, wherein a dose of about 1 mL to
about 100 mL of the topical pediculicidal formulation is applied
in (a).
(Id. at 31.)

4 Appellant’s January 18, 2017 Specification.
5 We find that the terms “weight” and “paragraphs” in the phrases “weight
olive oil” and “a non-ionic surfactant paragraphs,” as set forth in Appellant’s
claim 21, respectively, are typographical errors. Therefore, we read these
phrases as “olive oil” and “a non-ionic surfactant,” respectively.
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Grounds of rejection before this Panel for review:
Claims 21–30, 32–38, and 40–45stand rejected under 35 U.S.C.
§ 112(b).
Claims 21–24, 26–29, 32–38, and 40–45 stand rejected under 35
U.S.C. § 103 as unpatentable over the combination of Manetta,6 Campbell,7
and Pfeifer.8
Claims 21–29, 32–38, and 40–45 stand rejected under 35 U.S.C. § 103
as unpatentable over the combination of Manetta, Campbell, Pfeifer, and
Gans.9
Claims 21–24, 26–30, 32–38, and 40–45 stand rejected under 35
U.S.C. § 103 as unpatentable over the combination of Manetta, Campbell,
Pfeifer, and Guzzo.10
Claims 21, 25, 26, 28–30, 32–38, and 40–45 stand rejected under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 1, 5, 6, and 8–10 of Spring ’153.11
Claims 21–30, 32–38, and 40–45 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1, 5, 6, and 8–10 of Spring ’153 in view of Campbell.

6 Manetta et al., WO 2004/093886 A1, published Nov. 4, 2004.
7 Campbell et al., US 2003/0202997 A1, published Oct. 30, 2003.
8 Pfeifer et al., US 2005/0276763 A1, published Dec. 15, 2005.
9 Gans et al., US 2003/0040504 A1, published Feb. 27, 2003.
10 Guzzo et al., US 7,064,108 B2, published June 20, 2006.
11 Spring et al., US 8,791,153 B2, issued July 29, 2014.
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Claims 21–30, 32–38, and 40–45 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1–6, 13–15, 17, 18, 23, 25, and 26 of Spring ’595.12

DEFINITENESS:
ISSUE
Does the preponderance of evidence support Examiner’s conclusion
that: (a) the phrase “unformulated 0.5% ivermectin,” as set forth in
Appellant’s claim 21, is indefinite and (b) Appellant’s claim 30 improperly
depends from cancelled claim 1?
ANALYSIS
Claim 21:
Examiner finds that phrase “unformulated 0.5% ivermectin” indefinite
(see Office Act. 4 (Examiner query’s whether the phrase is intended to mean
“ivermectin in a solution of water,” “free ivermectin,” or ivermectin
“formulated in a way that is not recited in the claim”)). We are not
persuaded.
“The definiteness inquiry focuses on whether those skilled in the art
would understand the scope of the claim when the claim is read in light of
the rest of the specification.” Union Pacific Resources Co. v. Chesapeake
Energy Corp., 236 F.3d 684, 692 (Fed. Cir. 2001). On this record,
Appellant discloses:
The present invention may be prepared in concentrations of 1
%, 0.5%, and 0.25% of ivermectin in a formulation containing
deionized water, olive oil USP, surfactants, shea butter, sorbitan
tristearate, methylparaben, and propylparaben. For comparison

12 Spring et al., US 8,927,595 B2, issued Jan. 6, 2015.
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purposes, a Nix® formulation (Pfizer, Morris Plains, NJ)
containing 1 % permethrin (v/v), an Ovide® formulation
(Medicis, Phoenix, AZ) containing 0.5% malathion (v/v), a
non-formulated ivermectin solution (Chem Service Inc., West
Chester, PA), a placebo formulation (ivermectin formulation
sans ivermectin) and distilled, deionized water (ddH20) are
used as positive (Nix®, Ovide® and non-formulated
ivermectin), negative (placebo), and no treatment (ddH20)
controls.
(Spec. ¶ 102.)13 Thus, we find that a person of ordinary skill in this art,
reading Appellant’s claims in light of Appellant’s Specification, would
understand the phrase unformulated ivermectin to mean ivermectin in
“distilled, deionized water (ddH2O)” (see id.; see generally Appeal Br. 22;
Reply Br. 6–7).

Claim 30:
Examiner finds that Appellant’s claim 30 depends from Appellant’s
cancelled claim 1 and, “thus, the dependency of [Appellant’s] claim 30 is
unclear” (Office Act. 4). In addition, Examiner finds that Appellant does not
contest this rejection (see Ans.14 10 (Examiner finds that Appellant “does
not address or correct claim 30’s dependency”)).
“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)).

13 We recognize Appellant’s reference to paragraph 103 of its Specification
to support a finding “that ‘unformulated ivermectin’ means ivermectin in
water” (Appeal Br. 22). As Examiner points out, however, paragraph 103 of
Appellant’s Specification does not support Appellant’s contention.
14 Examiner’s May 9, 2019 Answer.
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Accordingly, the rejection of Appellant’s claim 30 is summarily
affirmed.15
CONCLUSION
The preponderance of evidence fails to support Examiner’s conclusion
that (a) the phrase “unformulated 0.5% ivermectin,” as set forth in
Appellant’s claim 21, is indefinite.
The rejection of claims 21–29, 32–38, and 40–45 under 35 U.S.C.
§ 112(b) is reversed.
The preponderance of evidence supports Examiner’s conclusion that
(b) Appellant’s claim 30 improperly depends from cancelled claim 1.
The rejection of claim 30 under 35 U.S.C. § 112(b) is affirmed.

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. 5).
FF 2. Manetta discloses a composition comprising: a) an oily phase
comprising fatty substances; b) at least one surfactant-emulsifier;

15 For examination purposes, Examiner interprets Appellant’s claim 30 as
depending upon Appellant’s claim 21 (Office Act. 4). We, therefore, do the
same.
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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. 5).
FF 3. Manetta discloses that the “oily phase” of its composition “may
comprise, for example, vegetable, mineral, animal or synthetic oils, silicone
oils, Guerbet 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”);
id. at 8:1–5 (Manetta discloses that fatty substances within the scope of its
invention includes beeswax); 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).
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. 5).
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. 5).
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FF 10. Manetta exemplifies a composition comprising:

(Manetta 21–22; see Office Act. 6 (Examiner finds that “[o]leyl alcohol,
cetyl alcohol, stearyl alcohol, methylparaben (methyl para-
hydroxybenzoate), and propylparaben (propyl para-hydroxybenzoate)
are . . . [examples of] nonionic surfactants and paraben preservative[s]” 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; see Ans. 6).
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. 5).
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FF 13. Examiner finds that “although Manetta . . . describe[s] ivermectin as
an antiparasitic medicinal product that is effective against lice . . . Manetta’s
topical compositions are intended for the treatment of rosacea and are not
necessarily administered to hosts who are infested with lice” (Office Act. 6).
FF 14. Campbell discloses “compositions are useful against a variety of
ectoparasites that afflict humans, animals, and plants, e.g., head lice, fleas,
body lice, crab lice, scabies, ticks, and plant parasites” (Campbell, Abstract;
see id. ¶ 15 (Campbell discloses “that ivermectin is able to kill head lice and
their eggs when topically applied” and that a “person of ordinary skill in the
art will realize that various compounds are available to act as carriers of the
ivermectin”); ¶ 19 (Campbell discloses a composition comprising “from
about 0.02% to about 1.0%” ivermectin); Office Act. 6).
FF 15. Campbell discloses
compositions are formulated to be applied to the scalp of a
person suffering from a head lice infestation and are left on the
treated person for a period of time. The compositions are
preferably left on the treated area for about 5-15 minutes, and
more preferably for about 10 minutes, with the effect of killing
lice and their eggs present within 1 hour or less.
(Campbell ¶ 5; see id. ¶¶ 7, 11, 19, and 24; Office Act. 6.)
FF 16. Examiner finds that the combination of Manetta and Campbell does
not disclose a composition comprising olive oil or shea butter (Office Act.
7).
FF 17. Examiner finds that Pfeifer discloses lice treating topical
compositions that comprise, inter alia, a) beeswax or shea butter and (b)
olive oil, sunflower oil, soya oil, almond oil, or palm oil (see Office Act. 7;
see also Pfeifer ¶ 37; id. ¶ 29 (Pfeifer discloses that its composition
comprises from 5 to 85% by weight of a lipid phase); id. ¶ 43 (Pfeifer
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discloses that its composition comprises up to 80% by weight nonpolar oil
components)).
FF 18. Examiner finds that the combination of Manetta, Campbell, and
Pfeifer do not teach treatment-resistant lice and relies on Gans to make up
for this deficiency (Office Act. 10–11).
FF 19. Examiner finds that the combination of Manetta, Campbell, and
Pfeifer do not teach treatment-resistant lice and relies on Guzzo to make up
for this deficiency (Office Act. 11–12).
ANALYSIS
The rejection over the combination of Manetta, Campbell, and Pfeifer:
Initially, we acknowledge Appellant’s contention that “Examiner has
not addressed . . . the level of ordinary skill in the art” (Appeal Br. 11–12
and 22). 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))).
Appellant’s only independent claim, claim 21, is drawn to a method
for the treatment or prophylaxis of lice comprising the application, to an area
infested with lice on a human, of 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 Appeal Br.
30). Similarly, Manetta discloses a topical composition comprising: (a)
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from 0.001% to 10% by weight ivermectin, (b) a solubilizer, (c) an oily
phase comprising, inter alia, vegetable oil (such as sesame oil, soybean oil,
sunflower oil, palm oil), or other substances, and mixtures thereof; and fatty
substances (such as beeswax), (d) a non-ionic surfactant, and (e) from 30%
to 95% water (see FF 1–10).
Examiner recognizes that Manetta does not disclose a composition
comprising olive oil or shea butter, but finds that Pfeifer discloses a topical
composition for the treatment of lice that, like Manetta, comprises an oily
phase comprising: a) beeswax or shea butter and b) olive oil, sunflower oil,
soya oil, almond oil, or palm oil sesame oil, soybean oil, sunflower oil, or
palm oil (see FF 16–17; cf. FF 2–3).
Thus, Examiner concludes, based on the combination of Manetta and
Pfeifer, that, at the time Appellant’s invention was made, it would have been
prima facie obvious to use olive oil, as disclosed by Pfeifer, for the oily
phase oil in Manetta’s composition, because Manetta and Pfeifer both
disclose a topical composition comprising, inter alia, fatty substances
composed of the same or similar compounds (see Office Act. 7 (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 1–17).
In addition, although Manetta discloses that ivermectin compositions
are known to be effective against some lice, Manetta discloses that its
composition is “intended for the treatment of rosacea” (see FF 11–13).
Campbell, however, makes up for the foregoing deficiency in Manetta by
disclosing a method of treating an area infested with lice on a human
comprising topically administering a composition comprising from about
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0.02 to about 1.0% ivermectin (see Office Act. 6; see also FF 14). Thus,
Examiner finds that it would have been prima facie obvious to a person of
ordinary skill in this art to treat an area infested with lice on a human, as
suggested by Campbell, by topically administering the composition
suggested by Manetta, Pfeifer, and Campbell (Office Act. 6–7; see FF 1–17).
We find no error in Examiner’s prima facie case of obviousness.
For the foregoing reasons, because the rejection of Appellant’s claim
21 is based on the combination of Manetta, Pfeifer, and Campbell, we are
not persuaded by Appellant’s contention that “Examiner has not established
that one of skill in the art would have been motivated to use the ivermectin-
containing topical composition disclosed in Manetta for treatment of humans
with lice, as in Campbell” (Appeal Br. 23; see also id. at 23–24; Reply Br.
2–3; cf. Ans. 4 (Examiner correctly asserts that Appellant “cannot show
nonobviousness by attacking references individually where the rejections are
based on combinations of references” (citation omitted))).
The amount of water in Manetta’s composition encompasses and,
therefore, makes obvious the water concentration recited in Appellant’s
claim (see Appeal Br. 30). See Iron Grip Barbell Co. v. USA Sports, 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. 24–25; see also Reply Br. 3–4; cf. Ans.
5).
Disclosed examples and preferred embodiments do not constitute a
teaching away from a broader disclosure or non-preferred embodiments. In
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re Susi, 440 F.2d 442, 446 n.3 (CCPA 1971). Therefore, we are not
persuaded by Appellant’s contention that “Campbell would have
discouraged use of the topical ivermectin composition disclosed in Manetta
for treatment of lice,” because “Campbell teaches that ‘[t]he present
invention eliminates the need for the inclusion of chemicals and agents that
are undesirable’” and prefers its compositions to not contain “(i) plant oils,
(ii) non-ionic surfactants, (iii) alcohols and (iv) water,” which Appellant
contends are components of Manetta’s composition (Appeal Br. 25
(alteration original) (citing Campbell ¶ 28); see also Reply Br. 3).
We are not persuaded by Appellant’s contention that a person of
ordinary skill in this art would not have selected olive oil and shea butter
from Pfeifer’s disclosure of appropriate components for its ivermectin
composition’s oily phase for use in the oily phase of Manetta’s ivermectin
composition (Appeal Br. 25–26; Reply Br. 4; cf. Ans. 6–7). 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.”).
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 Appeal Br. 30). 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
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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
Manetta’s composition would inherently achieve the mortality rate, set forth
in Appellant’s claim 21, when topically applied to an area infested with lice
on a human to treat or prevent lice, as suggested by Campbell (see FF 1–15;
see also Ans. 3–5). Therefore, we are not persuaded by Appellant’s
contention that Examiner failed to establish that the combination of Manetta,
Pfeifer, and Campbell suggest a method of treating lice that achieves the
mortality rate set forth in Appellant’s claim 21 (Appeal Br. 26; see also
Reply Br. 4; cf. Ans. 8).
Appellant failed to establish an evidentiary basis on this record to
support a finding that: (i) Examiner failed to establish that the combination
of Manetta, Pfeifer, and Campbell provides a person of ordinary skill in this
art with a “reasonable expectation of success” or (ii) “Examiner grossly
underestimates the challenge of developing an appropriate topical
formulation[] which consider many factors, including but not limited to the
intended use and site of action” (see Appeal Br. 26). See In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take
the place of evidence.”). Thus, we are not persuaded by Appellant’s
unsupported assertion that “one of skill in the art would not have been
motivated to combine the cited references, let alone have had a reasonable
expectation of success” (Appeal Br. 27).
“[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)).
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Appellant’s evidence of unexpected results are not based upon a comparison
with the closest prior art, i.e., Manetta (see generally Appeal Br. 27–28).
Therefore, we are not persuaded by Appellant’s contentions regarding
unexpected results (id.; cf. Ans. 9).

The rejection over the combination of Manetta, Campbell, Pfeifer, and
Gans:
Having found no deficiency in the combination of Manetta, Campbell,
and Pfeifer, we are not persuaded by Appellant’s contention that “Gans fails
to overcome . . . [Appellant’s asserted] deficiencies of Manetta, Campbell
and Pfeifer” (Appeal Br. 28; see also id. at 27; Reply Br. 5).

The rejection over the combination of Manetta, Campbell, Pfeifer, and
Guzzo:
Having found no deficiency in the combination of Manetta, Campbell,
and Pfeifer, we are not persuaded by Appellant’s contention that “Guzzo
does nothing to remedy . . . [Appellant’s asserted] deficiencies
of . . . [Manetta, Campbell and Pfeifer]” (Appeal Br. 28; see also id. at 27;
Reply Br. 5–6).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claims 21 under 35 U.S.C. § 103 as unpatentable over
the combination of Manetta, Campbell, and Pfeifer is affirmed. Claims 22–
24, 26–29, 32–38, and 40–45 are not separately argued and fall with claim
21.
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The rejection of claims 21 under 35 U.S.C. § 103 as unpatentable over
the combination of Manetta, Campbell, Pfeifer, and Gans is affirmed.
Claims 22–24, 26–30, 32–38, and 40–45 are not separately argued and fall
with claim 21.
The rejection of claims 21 under 35 U.S.C. § 103 as unpatentable over
the combination of Manetta, Campbell, Pfeifer, and Guzzo is affirmed.
Claims 22–24, 26–30, 32–38, and 40–45 are not separately argued and fall
with claim 21.

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 21, reproduced above, is representative.
On this record, Appellant does not contest the rejections of claim 21
under the judicially created doctrine of obviousness-type double patenting
(see Ans. 13–14 (Examiner finds that Appellant does not address the double
patenting rejections)). 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.
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CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness-type double patenting.
The rejection of claims 21, 25, 26, 28–30, 32–38, and 40–45 under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 1, 5, 6, and 8–10 of Spring ’153 is affirmed.
The rejection of claims 21–30, 32–38, and 40–45 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1, 5, 6, and 8–10 of Spring ’153 in view of Campbell is
affirmed.
The rejection of claims 21–30, 32–38, and 40–45 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1–6, 13–15, 17, 18, 23, 25, and 26 of Spring ’595 is affirmed.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
21–30,
32–38,
40–45
112(b) Indefiniteness 30 21–29,
32–38,
40–45
21–24,
26–29,
32–38,
40–45
103 Manetta,
Campbell, Pfeifer
21–24,
26–29,
32–38,
40–45

21–29,
32–38,
40–45
103 Manetta,
Campbell, Pfeifer,
Gans
21–29,
32–38,
40–45

21–24,
26–30,
32–38,
40–45
103 Manetta,
Campbell, Pfeifer,
Guzzo
21–24,
26–30,
32–38,
40–45

21, 25, 26,
28–30,
32–38,
40–45
Nonstatutory
Double Patenting,
Spring ’153
21, 25, 26,
28–30,
32–38,
40–45

21–30,
32–38,
40–45
Nonstatutory
Double Patenting,
Spring ’153,
Campbell
21–30,
32–38,
40–45

21–30,
32–38,
40–45
Nonstatutory
Double Patenting,
Spring ’595
21–30,
32–38,
40–45

Overall
Outcome
21–30,
32–38,
40–45

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