ARBOR PHARMACEUTICALS, LLC

Patent Trials and Appeals Board

Oct 27, 2020

2019005431 (P.T.A.B. Oct. 27, 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 10/27/2020
KING & SPALDING
1180 PEACHTREE STREET , NE
ATLANTA, GA 30309-3521
EXAMINER
BARHAM, BETHANY P
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
10/27/2020 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 REQUEST FOR REHEARING
Appellant1 requests rehearing under 37 C.F.R. § 41.52 of the Decision
entered July 8, 2020 affirming the obviousness rejections of claims 21–30,

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;
see also Appellant’s September 8, 2020 Request for Rehearing (Reh’g Req.)
2). Appellant’s Appeal Brief and Request for Rehearing are not paginated,
therefore, all page numbers refer to the documents as if they were numbered
consecutively beginning with the first page of each document.
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32–38, and 40–45 (see Reh’g Req. 5).2, 3 We have jurisdiction under
35 U.S.C. § 6(b). We DENY Appellant’s rehearing request.
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

2 Appellant does not request rehearing of the affirmance of the: (a) rejection
of claim 30 under 35 U.S.C. § 112(b) or (b) nonstatutory double patenting
rejections of record (see generally Decision 18; cf. Reh’g Req. 5).
3 This Appeal is related to Appeal 2020-000846 (Application 14/572,664)
(see Appeal Br. 4). A Decision affirming rejections under 35 U.S.C.
§ 112(b), 35 U.S.C. § 103, and nonstatutory double patenting was entered
into the record July 8, 2020. Office records report that Application
14/572,664 was abandoned on September 23, 2020.
4 Appellant’s January 18, 2017 Specification.
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3
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.)
Grounds of rejection before this Panel for review:6
I. 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,7 Campbell,8
and Pfeifer.9
II. 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.10
III. 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.11

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.
6 See Reh’g Req. 5.
7 Manetta et al., WO 2004/093886 A1, published Nov. 4, 2004.
8 Campbell et al., US 2003/0202997 A1, published Oct. 30, 2003.
9 Pfeifer et al., US 2005/0276763 A1, published Dec. 15, 2005.
10 Gans et al., US 2003/0040504 A1, published Feb. 27, 2003.
11 Guzzo et al., US 7,064,108 B2, published June 20, 2006.
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ANALYSIS
REJECTION I:
“Appellant respectfully asserts that the Board . . . made [five] errors in
reaching the [D]ecision issued July 8, 2020” (Reh’g Req. 5). We take each
asserted error in turn:

First:
During patent examination and reexamination, the
concept of prima facie obviousness establishes the framework
for the obviousness determination and the burdens the parties
face. See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780
F.3d 1376, 1384 (Fed. Cir. 2015). Under this framework, the
patent examiner must first set forth a prima facie case,
supported by evidence, showing why the claims at issue would
have been obvious in light of the prior art. In re Sullivan, 498
F.3d 1345, 1351 (Fed. Cir. 2007). Once the examiner sets out
this prima facie case, the burden shifts to the patentee to
provide evidence, in the prior art or beyond it, or argument
sufficient to rebut the examiner’s evidence. Id.
ACCO Brands Corp. v. Fellowes, Inc., 813 F.3d 1361, 1365–66 (Fed. Cir.
2016).
On this record, after summarizing Examiner’s findings, the Decision
states “[w]e find no error in Examiner’s prima facie case of obviousness”
(Decision 12; see generally id. at 10–12). Thus, the evidence on this record
establishes that Examiner set out a prima facie case of obviousness. Thus,
the evidentiary burden on this record was properly shifted to Appellant “to
provide evidence, in the prior art or beyond it, or argument sufficient to
rebut the examiner’s evidence.” ACCO, 813 F.3d at 1366; see also 37
C.F.R. § 41.37(c)(1)(iv) (The appeal brief shall contain “[t]he arguments of
appellant with respect to each ground of rejection.”); Gross v. Town of
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5
Cicero, III., 619 F.3d 697, 702 (7th Cir. 2010) (“Judges are not like pigs,
hunting for truffles buried in the record.”). On this record, Appellant failed
to carry their burden (see, e.g., Decision 6–17).
For the foregoing reasons, we are not persuaded by Appellant’s
contention:
that it is not the Appellant’s burden to “provide an evidentiary
basis on the record” regarding the Examiner's failure to
establish a reasonable expectation of success as a component of
prima facie obviousness. Rather, the prosecution history (to
which the Board has full access) provides adequate evidentiary
basis of the Examiner's failing in that regard. Appellant
respectfully reminds the Board that it is not the Appellant’s
burden to come forward with rebuttal arguments (including any
evidence) regarding the lack of reasonable expectation of
success until the Examiner has established a prima facie case of
obviousness.
(Reh’g Req. 5–6.)

Second:
Appellant contends:
While acknowledging the Examiner’s failure to make any
finding regarding the ordinary level of skill the art, the Board
dismissed this as non-problematic by stating that “the prior art
relied upon by Examiner is representative of the level of
ordinary skill in this art”, citing Okajima v. Bourdeau, 261 F.3d
1350, 1355 (Fed. Cir. 2001) for the proposition that “the
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.[’]” (internal citations omitted).
Appellant respectfully submits that the Board’s rationale
is conclusory, i.e., the Board provides no analysis of why the
prior art relied upon by the Examiner is representative of the
level of ordinary skill. . . .
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[And] the Okajima holding is not fairly applied to this
case.
(Reh’g Req. 6.) We are not persuaded.
[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.” Litton Indus. Prods., Inc. v. Solid State Sys. Corp.,
755 F.2d 158, 163 . . . (Fed. Cir. 1985); see also Custom
Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955,
963 . . . (Fed. Cir. 1986) (excusing failure to make express
findings as to the level of ordinary skill where there is no
showing that the court’s failure to make such a finding
influenced the ultimate determination). Okajima v. Bourdeau,
261 F.3d 1350, 1355 . . . (Fed. Cir. 2001) (affirming decision in
interference).
[A]n invention may be held to have been obvious (or
nonobvious) without a specific finding of a particular level of
skill or the reception of expert testimony on the level of skill
where, as here, the prior art itself reflects an appropriate level
and a need for such expert testimony has not been shown.
Chore-Time Equip., Inc. v. Cumberland, 713 F.2d 774, 779
n.2 . . . (Fed. Cir. 1983) (affirming court decision of invalidity).
. . . .
Curiously, the request does not urge alternative findings
on skill level that the Board should have made, does not point
to other findings that would have to change in view of a
properly determined skill level, and does not even explain
whether and why the obviousness determination as a whole is
wrong on the merits. There is no point to undoing the original
panel decision in the absence of some indication that it would
make a difference in the ultimate outcome. Cf. McNally v.
Mossinghoff, 673 F.2d 1253, 1254 . . . (CCPA 1982) (holding
no abuse of discretion in declining to perform a useless act).
Ex parte Jud, 2007 WL 9627858 *5–*6 (BPAI 2007) (Informative). See
also In re Giuffrida, 527 F. App’x 981, 986 (Fed. Cir. 2013) (unpublished):
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The absence of an express finding about 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.’” Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
Cir. 2001).
On this record, as in Giuffrida, “Examiner discussed what the prior art
taught and suggested while setting out the basis for his ultimate conclusions.
And the Board, largely agreeing with the Examiner, discussed the same prior
art and many of the same suggestions and teachings in it.” (Id.).

Third:
As our reviewing court has explained:
It is commonplace in administrative law for a reviewing body
within an agency to adopt a fact-finding body’s findings. On
judicial review, the adopted material is treated as if it were part
of the reviewing body’s opinion. . . .
This court does the same in the case of Board opinions adopting
patent examiners’ findings.
In re Cree, Inc., 818 F.3d 694, 698 n.2 (Fed. Cir. 2016) (internal citations
omitted); see also In re Hyatt, 211 F.3d 1367, 1370–71 (Fed. Cir. 2000); In
re Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990). Further, we direct
Appellant’s attention to our reviewing court’s Rule 36 decision in Carnahan
where the Federal Circuit affirmed the Board decision in Ex Parte
Carnahan, Appeal 2010-011437 (BPAI 2011), which affirmed “Examiner’s
rejection . . . for the reasons set forth in the Answer, which [the Panel]
incorporate[d] [t]herein by reference.” In re Carnahan, 440 F. App’x 927
(Fed. Cir. 2011) (nonprecedential).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that “the Board simply recites the Examiner’s obviousness
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rejection over the cited art to affirm the obviousness rejection, without
more” (Reh’g Req. 7).

Fourth:
As the Decision makes clear:
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 nonionic
surfactant, and (e) about 30% to 40% by weight water (see
Appeal Br. 30). Similarly, Manetta discloses a topical
composition comprising: (a) 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).
(Decision 10–11 (emphasis added).)
Although Appellant emphasizes that “Manetta is not even identical to
the composition in the pending claims” (Reh’g Req. 8); Appellant failed to
explain why the Board erred in holding that “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 Decision 14; see also id. at 10–13 (explaining how the
evidence of record supports the holding)). As the Decision explains,
Appellant failed to establish an evidentiary basis on this record to support
the conclusion that Manetta’s topical compositions formulated as a shampoo
would not have the same mortality rate as required by Appellant’s claimed
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invention (see Decision 15 (“Appellant’s evidence of unexpected results are
not based upon a comparison with the closest prior art, i.e., Manetta”)).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that the Board failed to “meet the high standard for inherent
obviousness required by the Federal Circuit” (Reh’g Req. 7).

Fifth:
As the Decision explains:
Disclosed examples and preferred embodiments do not
constitute a teaching away from a broader disclosure or non-
preferred embodiments. In 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).
(Decision 12–13.) Thus, we are not persuaded by Appellant’s contention
that the Decision’s reliance on Susi “discounts the disclosure in Campbell
that teaches away from making the necessary combination” (Reh’g Req. 8).
For the same reasons, we are not persuaded by Appellant’s contention that
“it’s hard to imagine how describing a component as ‘undesirable’ and
something to be eliminated would not be considered a criticism” (id. at 8–9).
Teaching away requires “clear discouragement” from implementing a
technical feature. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017).
Stated differently, “[a] reference may be said to teach away when a person
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of ordinary skill, upon reading the reference, would be discouraged from
following the path set out in the reference, or would be led in a direction
divergent from the path that was taken by the applicant.” In re Gurley, 27
F.3d 551, 553 (Fed. Cir. 1994). Thus, the “mere disclosure of alternative
designs does not teach away.” In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir.
2004). To the contrary, the existence of better alternatives in the prior art
does not mean that an inferior combination is inapt for obviousness
purposes. Gurley, 27 F.3d at 553.
Appellant’s contentions, on this record, are substantially similar to
“Gurley’s position . . . that a reference that ‘teaches away’ can not serve to
create a prima facie case of obviousness.” Id.; cf. Reh’g Req. 8–9. We
agree with our reviewing court
that this is a useful general rule. However, such a rule can not
be adopted in the abstract, for it may not be applicable in all
factual circumstances. Although a reference that teaches away
is a significant factor to be considered in determining
unobviousness, the nature of the teaching is highly relevant, and
must be weighed in substance. A known or obvious
composition does not become patentable simply because it has
been described as somewhat inferior to some other product for
the same use.
Gurley, 27 F.3d at 553.
On this record, Campbell teaches that its “‘invention eliminates the
need for the inclusion of chemicals and agents that are undesirable’”
(Decision 13). Campbell then identifies chemicals and agents that may
“preferably” be eliminated from its composition (id.). As Gurley explains,
“the nature of th[is] teaching is highly relevant, and must be weighed in
substance.” Gurley, 27 F.3d at 553. Weighing the substance of Campbell’s
highly relevant disclosure, Campbell suggests, but does not require, that
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undesirable chemicals and agents may be excluded from its composition (see
Decision 13; see also id. at 9 (“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’”)). Thus, although Campbell may suggest
that compositions with certain chemicals and agents are less desirable or,
perhaps, somewhat inferior, Campbell does not teach away from Appellant’s
claimed invention or Campbell’s combination with Manetta, as asserted by
Appellant.

REJECTIONS II and III:
Appellant contends:
With respect to the separate rejection of claims 21-29, 32-38
and 40-45 over Manetta, Campbell in further view of Gans et al
(US 2003/00040504)(“Gans”), the Examiner simply states
“[h]aving 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" and similarly
with respect to Guzzo (See Board Decision, p. 14). Appellant
respectfully submits these rejections suffer the same
deficiencies as those described above with respect to Manetta,
Campbell, and Pfeifer.
(Reh’g Req. 9 (alteration original).)
Having found no deficiency with respect to the combination of
Manetta, Campbell, and Pfeifer, we are not persuaded by Appellant’s
contentions regarding Rejections II and III.

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DECISION SUMMARY
Outcome of Decision on Rehearing:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Denied Granted
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

Overall
Outcome
21–30,
32–38,
40–45

Final Outcome of Appeal after Rehearing:
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

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13
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
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).

DENIED