Epikinetics Pharma, LLC

Patent Trials and Appeals Board

May 4, 2020

2019006069 (P.T.A.B. May. 4, 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.
14/283,073 05/20/2014 Christopher J. Dannaker Dannaker-0801CIP 3557
36787 7590 05/04/2020
BLYNN L. SHIDELER
THE BLK LAW GROUP
3500 BROKKTREE ROAD
SUITE 200
WEXFORD, PA 15090
EXAMINER
RICCI, CRAIG D
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
05/04/2020 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):
blynn@BLKLawGroup.com
cbelleci@BLKLawGroup.com
patents@BLKLawGroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER J. DANNAKER
Appeal 2019-006069
Application 14/283,073
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
ELIZABETH A. LAVIER, Administrative Patent Judges.
LAVIER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–16. 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(a). Appellant identifies the real party in interest as Christopher J.
Dannaker. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
The claims are directed to topical treatments for skin conditions.
Claims 1, 3, and 10 are illustrative:
1. A waterborne topical composition for the treatment of acne
vulgaris, rosacea, seborrheic dermatitis or other skin conditions
comprising effective amounts of azelaic acid, niacinamide, and
wherein the composition demonstrates a penetration rate of at least
5% active ingredient/hr, within 2.5 hours of application to human
skin.

3. A waterborne topical composition for the treatment of acne
vulgaris, rosacea, seborrheic dermatitis or other skin conditions
comprising azelaic acid present in an amount of at least 10 percent by
weight and effective amounts of niacinamide and cyclodextran present
in an amount less than 6 percent by weight.

10. The waterborne topical composition of claim 3 and further
comprising one or more alcohols, a surfactant, isopropyl palmitate,
sorbitol, and lactic acid.

Appeal Br. 16–17 (Claims Appendix).
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REFERENCES
The Examiner relies on the following references:
Name Reference Date
Franke US 6,534,070 Mar. 18, 2003
Dannaker ’296 US 2010/0004296 A1 Jan. 7, 2010
Dannaker ’108 US 8,729,108 B2 May 20, 2014
Draelos et al., Niacinamide-Containing Facial Moisturizer Improves Skin
Barrier and Benefits Subjects With Rosacea, 76 THERAPEUTICS FOR THE
CLINICIAN 135–141 (2005)
Manosroi et al., Enhancement of the release of azelaic acid through the
synthetic membranes by inclusion complex formation with
hydroxypropyl-β-cyclodextrin, 293 INT’L J. PHARMACEUTICS 293 235−240
(2005)
REJECTIONS
1. Claim 1 stands rejected under 35 U.S.C. § 103 as unpatentable
over Franke and Draelos. Non-Final Action 5.2
2. Claims 2–16 stand rejected under 35 U.S.C. § 103 as unpatentable
over Dannaker ’296 in view of Manosroi. Non-Final Action 7.
3. Claim 1 stands rejected on the ground of nonstatutory double
patenting as unpatentable over claims 1–8 of Dannaker ’108. Non-
Final Action 13.
4. Claims 2–16 stand rejected on the ground of nonstatutory double
patenting as unpatentable over claims 1–8 of Dannaker ’108 and
Manosroi. Non-Final Action 14.
PROCEDURAL BACKGROUND
The present application is a continuation-in-part of U.S. Patent
Application No. 12/486,625 (the ’625 application). See Application Data

2 Non-Final Office Action dated August 9, 2017.
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Sheet, July 29, 2014. The ’625 application published as Dannaker ’296, and
issued as Dannaker ’108. Claim 1 is supported by the ’625 application as
originally filed. See Non-Final Action 5. Claims 2–16 are not; these claims
“comprise cyclodextran[,] which was not disclosed in the [’625
application].” Id. Accordingly, the Examiner finds that claim 1 has a
priority date of June 17, 2008, while claims 2–16 have an earliest effective
filing date of May 20, 2014. See id.
In response to a restriction requirement, Appellant elected:
the waterborn[e] topical composition of the invention in the form
of an emulsion and including the combination of azelaic acid,
niacinamide, cetyl alcohol, stearyl alcohol, sodium lauryl sulfate,
isopropyl palmitate, glycerin, sorbitol, lactic acid, benzyl
alcohol, and a cyclodextrin, specifically hydroypropyl beta
cyclodextran as the cyclodextran agent.
Remarks in Response to Election/Restriction Requirement (Aug. 17, 2015).

OPINION
A. Rejection 1
The Examiner finds, inter alia, that Franke teaches treating skin
conditions with a topical waterborne gel comprising azelaic acid (most
preferably 14–16% by weight of the composition), and that Draelos teaches
applying facial moisturizers comprising niacinamide to reduce dryness. See
Non-Final Action 5–6 (citing Franke 1:24–26, 1:34–35, 2:45–50; Draelos
135). As the compositions of Franke and Draelos both treat rosacea, the
Examiner finds it would have been obvious to the ordinarily skilled artisan
to have combined them, with a reasonable expectation of success, to form a
third composition for the same purpose. See id. at 6. The Examiner further
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concludes that the penetration rate limitations of claim 1 would necessarily
have followed from the administration of the composition:
In the instant case, the claimed and prior art products are
substantially identical. As such, absent evidence to the contrary,
it is asserted that the prima facie obvious composition for the
treatment of rosacea comprising azelaic acid and niacinamide
would necessarily provide a penetration rate of at least 5% active
ingredient/hour, within 2.5 hours of application to human skin.
Id. at 7 (emphases omitted).
Appellant has not persuaded us of any reversible error by the
Examiner in rejecting claim 1. First, Appellant argues generically that the
references as a whole would not yield the suggested composition “for
reasons detailed in the specification as well as through-out the prosecution of
the parent application which arguments are incorporated herein by
reference,” and further “not[ing] the test results set forth in the entire
prosecution history of the present application and the parent that does
address and support the unique penetration rates claimed.” Appeal Br. 12.
Appellant’s argument by reference is improper, as Appellant must present all
arguments in Appellant’s brief(s) to the Board. See 37 C.F.R.
§ 41.37(c)(1)(iv) (2011) (“Any arguments or authorities not included in the
brief or a reply brief filed pursuant to § 41.41 will be refused consideration
by the Board, unless good cause is shown.”); see also DeSilva v.
DiLeonardi, 181 F.3d 865, 867 (7th Cir. 1999) (“[I]ncorporation [by
reference] is a pointless imposition on the court’s time. A brief must make
all arguments accessible to the judges, rather than ask them to play
archaeologist with the record.”). Insofar as Appellant argues that the
references as a whole do not support the rejection as part of a general
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allegation of error (see also Reply Br. 5), we are also not persuaded. As the
Examiner explains, both Franke and Draelos concern themselves with
topical treatments for skin conditions including rosacea; combining their
teachings to make another composition for treating rosacea would have been
obvious to the ordinarily skilled artisan. “It is prima facie obvious to
combine two compositions each of which is taught by the prior art to be
useful for the same purpose, in order to form a third composition which is to
be used for the very same purpose.” In re Kerkhoven, 626 F.2d 846, 850
(CCPA 1980). This is because “the idea of combining [the compositions]
flows logically from their having been individually taught in the prior art.”
Id.
Second, Appellant takes issue with the Examiner’s conclusion that the
penetration rate limitation of claim 1 flows inherently from the teaching of
the prior art, specifically: “The examiner does not suggest how the
niacinimide containing skin cream composition of the secondary reference
would be incorporated into the hydrogel structure of the primary reference.
Hydrogel structures are sensitive to [p]H and other factors and the structural
integrity of the hydrogel can be compromised.” Appeal Br. 13 (emphasis
added); see also Reply Br. 5. This argument is unpersuasive for independent
reasons. Initially, as the first (emphasized) sentence in the quotation above
from Appeal Brief, Appellant wrongly presumes that the Examiner’s
combination of the references necessarily yields a hydrogel (with which the
references do not expressly teach using niacinamide) rather than a cream
(with which Draelos uses naicinamide). Cf. Appeal Br. 14 (asserting that
“there is no teaching or suggestion of actually combining the cream of the
secondary reference into the hydrogel formulation of the primary
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reference”). As the Examiner points out, however, Franke discloses creams
and hydrogels (see Ans. 7 (citing Franke 1:34–35, 2:45–50)), and thus it
would have been obvious to add azelaic acid as taught in Franke to the
niacinamide-containing cream of Draelos with a reasonable expectation of
success (see id. at 7–8). Furthermore, Appellant’s assertions regarding the
difficulties of using niacinamide are not supported by evidence of record.
Appellant cites two unpublished dissertations (and citing references therein),
for the alleged physiochemical challenges in topical delivery of niacinamide.
Appeal Br. 13–14. These dissertations do not appear to have been entered in
the record; accordingly we cannot give evidentiary weight to the statements
Appellant makes in regard thereto. Even if we were to take these statements
at face value, however, we would not find them persuasive. As discussed
above, the prior art (Draelos) amply demonstrates the use of niacinamide in
creams. For these reasons, we conclude that Appellant has not persuasively
demonstrated that the Examiner’s reliance on inherency for the penetration
rate limitation of claim 1 was in error. See In re Best, 562 F.2d 1252, 1255
(CCPA 1977) (“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.”).
Having considered each of Appellant’s arguments in support of claim
1, Appellant has not persuaded us that the Examiner erred reversibly in
rejecting claim 1. We affirm Rejection 1.
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B. Rejection 2
The Examiner finds that Dannaker ’296 teaches each of the limitations
of claims 2–16 except for cyclodextran.3 See Non-Final Action 8–9 (citing
Dannaker ’296 ¶¶ 30, 61, claim 2). For cyclodextran, the Examiner cites
Manosroi, which teaches the enhancement of azelaic acid release rates using
hydroxypropyl beta cyclodextran (“HPβCD”), a form of cyclodextran. See
id. at 9 (citing Manosroi Abstract, 238). The Examiner concludes:
it would have been obvious prior to the effective filing date of
the instant invention to further include hydroxypropyl beta
cyclodextran (i.e., cyclodextran (note that previously dependent
claims clearly establish that HPβCD is a cyclodextran as
instantly claimed)) in the Danmaker [sic] composition, based on
Manosroi et al. The skilled artisan would have done so in order
to enhance release rates of azelaic acid with a reasonable
expectation of success. Furthermore, in doing so, it would have
been obvious to determine the optimal amount of hydroxypropyl
beta cyclodextran to include, in order to best achieve these
desired results.
Id. at 9–10 (emphases omitted).
Appellant presents two arguments, neither of which is persuasive.
First, Appellant argues that 35 U.S.C. § 121 bars the Examiner from using
the publication of the parent application, i.e., Dannaker ’296, against the
present claims, because of the Examiner’s entry of a restriction requirement
in the present application. See Appeal Br. 8 (citing Requirement for
Restriction/Election (June 17, 2015)). Section 121, entitled “Divisional

3 The Examiner’s findings also pertain to the subject matter elected by
Appellant in response to a restriction requirement. See Requirement for
Restriction/Election (June 17, 2015); Response to Restriction/Election (Aug.
17, 2015).
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applications,” creates “a safe harbor to patents that issue on applications
filed as a result of a restriction requirement,” Pfizer, Inc. v. Teva
Pharmaceuticals USA, Inc., 518 F.3d 1353, 1359 (Fed. Cir. 2008). As the
Pfizer court explained, § 121 is “limited to divisional applications.” Id. at
1362. The present application is a continuation-in-part of the application
that published as Dannaker ’296, not a divisional. Accordingly, the § 121
safe harbor does not apply. The Restriction Requirement issued by the
Examiner in the course of the prosecution of this application has no bearing
on this issue.
Second, and with respect to claims 3 and 15 in particular, Appellant
argues that Manosroi teaches away from the claimed combination. See
Appeal Br. 9–10; Reply Br. 3–4. Specifically, Appellant points to
Manosroi’s teaching of a molar ratio of azaelaic acid to HPβCD of 1:1,
which by Appellant’s calculation would amount to 11% of HPβCD by
weight, or “almost double the claimed amount of 6% by weight.” Appeal
Br. 9 (emphases omitted). According to Appellant, the 1:1 molar ratio in
Manosroi is a “critical amount,” which the Examiner “cannot ignore.” Id.
But Manosroi does not test a range of molar ratios; rather “[i]n all systems,
azelaic acid to HPβ3CD molar ratios were 1:1.” Manosroi 236. Appellant
points to no evidence, and we discern none, that Manosroi views the 1:1
ratio as “critical.” Nor does Appellant point to a statement in Manosroi
suggesting that other molar ratios of azelaic acid and HPβ3CD would not
increase the release rate of the azelaic acid. Indeed, simply teaching another
way is not “teaching away.” See In re Fulton, 391 F.3d 1195, 1201 (Fed.
Cir. 2004) (“The prior art’s mere disclosure of more than one alternative
does not constitute a teaching away from any of these alternatives because
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such disclosure does not criticize, discredit, or otherwise discourage the
solution claimed.”); In re Dunn, 349 F.2d 433, 438 (CCPA 1965) (drawing
contrast between “teaching of an alternative or equivalent method” and
“teaching away”). Like our reviewing court, “[w]e will not read into a
reference a teaching away from a process where no such language exists.”
DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1364 (Fed. Cir. 2006). We affirm Rejection 2.
C. Rejection 3
The Examiner finds that claim 1 of the present application is taught by
claim 1 of Dannaker ’108. Non-Final Action 13. Claim 1 of Dannaker ’108
recites:
A waterborne topical composition for the treatment of acne
vulgaris, rosacea, seborrheic dermatitis or other skin conditions
comprising effective amounts of azelaic acid, niacinamide, and
glycerin, and wherein the composition demonstrates a
penetration rate of at least 5% active ingredient/hr, within 2.5
hours of application to human skin, wherein the azelaic acid is
present in an amount of at least 4 percent by weight and the
glycerin is present in an amount of up to 10 percent by weight,
and wherein the waterborne composition is in the form of one of
a liquid, emulsion and microemulsion.
Dannaker ’108 8:55–64 (emphasis added).
Appellant attempts to distinguish the present claim 1 from claim 1 of
Dannaker ’108 on the basis that glycerin is required by claim 1 of Dannaker
’108 but only optional in claim 1.4 See Appeal Br. 10; see also Reply Br. 4.

4 Appellant specifically asserts that “[t]he requirement of including glycerin
[in claim 1 of Dannaker ’108] is believed to be distinct from the elected
embodiment in which such is only an optional ingredient.” Appeal Br. 10.
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As the Examiner correctly notes, however, claim 1 of the present application
uses the open-ended transitional term “comprising,” and therefore
encompasses compositions that also include glycerin. Ans. 13 (citing MPEP
§ 2111.03(I) and case law cited therein). In the Reply Brief, Appellant again
highlights the inclusion of glycerin in claim 1 of Dannaker ’108, but takes
issue with the restriction requirement, asserting that “the [E]xaminer seems
to be attempting to maintain a restriction requirement but not have his
positions so limited.” Reply Br. 4. Insofar as Appellant is challenging the
propriety of the Restriction Requirement, such an objection relates to
petitionable subject matter under 37 C.F.R. § 1.181. Accordingly, this
matter is not before us, as we lack jurisdiction over petitionable matters. See,
e.g., MPEP § 706.01 (“[T]he Board will not hear or decide issues pertaining
to objections and formal matters which are not properly before the Board.”);
see also MPEP § 1201 (“The Board will not ordinarily hear a question that
should be decided by the Director on petition….”). Insofar as Appellant is
challenging the Examiner’s focus on claim 1 as written rather than the
elected composition, this distinction does not matter vis-à-vis glycerin:
compositions including glycerin fall within the scope of claim 1 as written
and within the elected composition.
We affirm Rejection 3.
D. Rejection 4
With respect to claims 2–16, the Examiner makes the following
findings in support of the nonstatutory double patenting rejection:

This is not an accurate characterization of the elected composition, which (as
quoted supra) expressly recites glycerin.
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Although the claims at issue are not identical [to claims 1–8 of
Dannaker ’108], they are not patentably distinct from each other.
The ’108 patent similarly claims (and further discloses)
waterborne topical compositions which differ from those
instantly claimed in that they do not comprise cyclodextran. Yet,
it would have been obvious to further include hydroxypropyl
beta cyclodextran in said compositions based on Manosroi et al
for the same reasons as discussed above [with respect to the
§ 103 rejection].
Non-Final Action 14 (emphases omitted).
Appellant reiterates the § 121 and teach-away (as to Manosroi)
arguments presented with respect to the obviousness rejection of these
claims (i.e., Rejection 2). See Appeal Br. 10–11. These arguments are
equally unpersuasive as applied here.
However, with respect to claims 10–14 specifically, Appellant further
argues that claims 1–8 of Dannaker ’108 do not teach or suggest the
particular limitations therein. See Appeal Br. 11. As introduced above,
claim 10 depends from claim 3 and recites that the composition also
comprises “one or more alcohols, a surfactant, isopropyl palmitate, sorbitol,
and lactic acid.” Appeal Br. 17 (Claims Appendix). Claim 11 provides
specific options for the alcohol recited in claim 10, and claim 12 specifies
that the surfactant of claim 10 comprises sodium lauryl sulfate. See id.
Appellant is correct that the claims of Dannaker ’108 do not expressly recite
the specific limitations of claims 10–12 of the present application.5 Indeed,

5 As to claims 13 and 14, however, and as the Examiner points out, claims 1
and 4 of Dannaker ’108 provide support for their additional limitations. See
Ans. 17. In particular, the additional subject matter of claim 13 (i.e.,
glycerin and the composition being in the form of a liquid, emulsion, or
microemulsion (see Appeal Br. 17 (Claims Appendix)) is taught by claim 1
of Dannaker ’108 (Dannaker ’108 8:55–64). The additional subject matter
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the Examiner does not point to corollary disclosures for claims 10–12 in the
Dannaker ’108 claims, but rather finds that “it would have been obvious to
include each of these ingredients which are disclosed by U.S. Patent No.
8,729,108 at Column 5, Lines 10–17.” Ans. 17. “The determining factor in
deciding whether or not there is double patenting is the existence vel non of
patentable difference between two sets of claims.” Gen. Foods Corp. v.
Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1278–79 (Fed. Cir. 1992)
(emphasis omitted). Thus, while the disclosure of the reference patent (or
application) may be used for some purposes (i.e., claim construction) in a
double patenting analysis, it is not to be used as prior art. See MPEP
§ 804(II)(B)(2)(a).6
Accordingly, we affirm Rejection 4 with respect to claims 2–9, 15,
and 16, but reverse with respect to claims 10–14.
CONCLUSION
The Examiner’s rejections are affirmed, except as to the nonstatutory
double patenting rejection of claims 10–14.
DECISION SUMMARY
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed

claim 14 (i.e., that “the composition is essentially free of azelaic acid esters”
(Appeal Br. 17 (Claims Appendix)) can be found in claim 4 of Dannaker
’108 (Dannaker ’108 9:4–5).
6 To be sure, the pre-grant publication of Dannaker ’108, i.e., Dannaker
’296, is prior art to the present claims, as reflected in the Examiner’s reliance
on Dannaker ’296 (and Manosroi) in rejecting claims 2–16, as discussed
supra with respect to Rejection 2. The passage in Dannaker ’296
corresponding to column 5, lines 10–17 in Dannaker ’108 (cited by the
Examiner on page 17 of the Answer) can be found at paragraph 30.
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1 103 Franke, Draelos 1
2–16 103 Dannaker ’296,
Manosroi
2–16
1 nonstatutory
double patenting
1
2–16 nonstatutory
double patenting
2–9, 15, 16 10–14
Overall
Outcome
1–16

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED