Ex Parte Kulesza

Patent Trial and Appeal Board

Dec 21, 2017

13795663 (P.T.A.B. Dec. 21, 2017)

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.
13/795,663 03/12/2013 John E. Kulesza YPI-l 1902/16 3892
25006 7590 12/26/2017
DTNSMORF fr SHOHT T T P
EXAMINER
900 Wilshire Drive ROBINSON, LISBETH C
Suite 300
TROY, MI 48084 ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
12/26/2017 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):
MichiganPatTM @ dinsmore. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN E. KULESZA
Appeal 2017-001333
Application 13/795,663
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to an active
agent topical delivery composition. The Examiner rejected the claims as
obvious and on the ground of provisional obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
“The comfort associated with application of topical agents is related in
part to the rate of evaporation of the applied composition on the skin” (Spec.
13). “Combining topical agents with volatile silicones has been found to
provide a pleasing application. Silicones ... are poor solvents for
1 Appellant identifies the Real Party in Interest as the inventor, John Kulesza
(see App. Br. 2).
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Application 13/795,663
hydrophobic organic active agents” (id). “Prior formulations prefer
alcohols such as ethyl alcohol as an organic solvent to solubilize the active
agent in a silicone” (id. at 4). “Ethyl alcohol, as used in [a prior art] retinoid
composition . . . contributes to skin irritation and dryness” (id. at 5). “Thus,
there exists a need for a hydrophobic active agent delivery system that
provides pleasing application and does not contribute to toxicity” (id. at 6).
The Claims
Claims 1—7, 16, 17, and 23 are on appeal. Independent claim 1 is
representative and read as follows:
1. An active agent topical delivery composition comprising:
ethyl trisiloxane;
an active agent selected from the group consisting of
vitamin A or vitamin A derivatives;
disiloxane; and
isododecane;
said composition having less than 15% of an alcohol of 6
carbon atoms or fewer;
said composition free of water, and said active agent
fully solubilized in said composition.
The Issues
A. The Examiner rejected claims 1—7, 16, 17, and 23 under 35 U.S.C.
§ 103(a) as obvious over Harrison,2 Belsil RG 90,3 and Kulesza4 (Final Act.
5-12).
2 Harrison et al., US 8,900,607 Bl, issued Dec. 2, 2014.
3 Belsil ® RG 90, Technical Data Sheet,
http://www.brenntagspecialties.com/ en/downloads/
Products/Personal_care/Wacker_Silicones/Belsil RG_90 TDS.pdf (2011).
4 Kulesza, J., US 2011/0142769 Al, published June 16, 2011.
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B. The Examiner rejected claims 1—7, 16, 17, and 23 as unpatentable
over claims 22, 23, and 25—39 of copending US application 13/685,244,
Auguste,5 and Harrison ’328.6
A. 35 U.S.C. § 103(a) over Harrison, Belsil RG 90, andKulesza
The Examiner finds Harrison teaches “a clear composition comprising
about 0.045% retinal [vitamin A derivative], low molecular weight
dimethicone . . . which is free of water and comprises less than 15% of an
alcohol having 6 or fewer carbons (0%) (Ex. 13)” (Final Act. 5—6). The
Examiner find Harrison teaches “disiloxane (aka hexamethyldisiloxane) as
an alternative to Tow molecular weight dimethicone’” (id. at 6). The
Examiner finds “the retinal is fully solubilized in the clear compositions
suggested by Harrison” (id.).
The Examiner acknowledges that Harrison teaches “isoparaffmic
solvents . . . but not the species isododecane” which is required by claim 1
(Final Act. 7). The Examiner finds Belsil RG 90 teaches “a transparent gel
comprising a crosslinked high-molecular weight siloxane polymer dispersed
in isododecane” (id.).
The Examiner also acknowledges Harrison teaches “the genus of
linear volatile silicones . . . and teach[es] glycol ethers as organic solvents”
but does not teach the specifically claimed “species ethyl trisiloxane” (id. at
8). The Examiner finds “Kulesza teaches ethyl trisiloxane” (id.).
5 Auguste, F., US 2004/0197284 Al, published Oct. 7, 2004.
6 Harrison et al., US 2014/0018328 Al, published Jan. 16, 2014.
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Application 13/795,663
The Examiner finds it obvious “to modify the composition of Harrison
et al. by selecting BELSIL RG 90 as the dimethicone crosspolymer, to
impart the skin feel, distribution and film forming properties taught by
BELSIL RG 90” (Final Act. 7). The Examiner further finds it obvious “to
modify the composition of Harrison et al. comprising at least some
disiloxane, by substituting some of the low molecular weight dimethicone
with ethyl trisiloxane [as required by the claim] as an additional carrier for
the vitamin A because these are “functionally equivalent carriers for use
with vitamin A” (Final Act. 8—9).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner’s conclusion
that Harrison, BELSIL RG 90, and Kulesza render claim 1 obvious?
(ii) If so, has Appellant presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness?
Findings of Fact
1. Example 13 of Harrison teaches a composition consisting of:
Retinol- 15D (a 15% solution of all trans 0.3% retinol in
caprylic/capric triglyceride, stabilized with 1% BHT)
Low molecular weight dimethicone 80.0%
Dimethicone crosspolymer 19.7%
(Harrison 19:22—27).
2. Example 13 of Harrison teaches: “Retinol- 15D is dissolved in
the low molecular weight dimethicone . . . the compositions in the opaque
containers are found to be optically clear, and to contain active retinol”
(Harrison 19:28-40).
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Application 13/795,663
3. Harrison teaches the “compositions may include low molecular
weight silicone in a range of about 5% to about 95% (weight %). . . In one
embodiment, the compositions include about 35% to about 75%
hexamethyldisiloxane and/or low molecular weight dimethicones” (Harrison
14:31-35).
4. Harrison teaches: “Low molecular weight silicones including
hexamethyldisiloxane and low molecular weight dimethicones are clear
fluids, and are essentially odorless, nontoxic, nongreasy and nonstinging.
These fluids are nonirritating to skin, and exhibit enhanced spreadability and
ease of application to the skin” (Harrison 14:36-40).
5. Belsil RG 90 teaches “BELSIL® RG 90 elastomer gel is a
crosslinked high-molecular weight organosiloxane polymer dispersed in
isododecane. It is delivered as a transparent to semitransparent gel” (Belsil
RG 90 1, col. 1).
6. Belsil RG 90 teaches “BELSIL® RG 90 is easy to distribute on
skin and gives a nice, silky skin feel. The evaporation of isododecane leaves
a non-tacky film which improves transfer- and water resistance of cosmetic
formulations” (Belsil RG 90 1, col. 1).
7. Belsil RG 90 teaches a “preferred way of incorporation into a
formulation is to disperse BELSIL® RG 90 in suitable oils and solvents.
Alternatively, it can be added to the finished formulation. It provides a silky
skin feel combined with hydrophobic film forming properties” (Belsil RG 90
1, col. 1).
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8. Kulesza teaches: “Lipophilic skin care active agents such as
retinoids are generally applied topically to reduce the appearance of aging,
for other cosmetic purposes, or to treat a skin condition” (Kulesza 13).
9. Kulesza teaches: “Examples of vitamin A or its derivatives
illustratively include retinoids such as retinal, retinoic acid, retinyl ester,
retinal, tretinoin, isotretinoin, adapalene, tazarotene, and the like” (Kulesza
121).
10. Kulesza teaches “active agent is preferably provided in a carrier
. . . Optionally, a carrier is ethyl trisiloxane. It is appreciated that an
inventive composition optionally includes more than one carrier” (Kulesza
128).
11. Kulesza teaches the “inventive composition is optionally
formulated with levels of organic solvent. . . Optionally, an organic solvent
is absent. . . Optionally, an organic solvent is ethoxydiglycol present at 10
percent w/w or less” (Kulesza 131). Kulesza teaches “stable solutions of
active compounds in the carrier can be prepared with less than 15 percent
w/w organic solvent when combined with a vehicle at 5 percent to 40
percent w/w” (Kulesza 132).
12. Example 1 of Kulesza teaches:
A Formula A composition is mixed containing 3.0 percent
ethoxydiglycol, 0.5 percent Laureth-4, 0.10 percent
hydroxypinnacolone retinoate, 0.05% BHT, 2.0 percent
SYMREPAIR, 2.0 percent Tetrahexyldecyl ascorbate, 0.50
percent Tocopherol, 20 percent methoxyonafluorobutane, 1.0
percent SILOX GT, and the remainder Ethyl trisiloxane.
(Kulesza 148).
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13. The Specification teaches the “inventive composition includes
an active agent combined with an organosiloxane carrier and a compatible
volatile vehicle” (Spec. 116).
14. The Specification teaches:
As used herein the term “active agent” refers to a molecule
suitable for delivery to the skin or mucosal regions of a subject.
Optionally, an active agent has pharmaceutical activity and is
present for the treatment or prevention of a skin condition . . .
Examples of active agents illustratively include: vitamin A or
its derivatives; hydroxy acids; aromatic molecules such as
benzoyl peroxide and resorcinol; azelaic acid; antimicrobials
such as azelaic acid, erythromycin, sodium sulfacetamide,
tetracycline and derivatives, and clindamycin; anti-neoplastic
agents and/or ophthalmic agents illustratively including 5-
fluorouracil, doxorubicin, imiquimod, and sodium [o-(2,6-
dichloranilino) phenyl] acetate; anti-viral agents illustratively
ganciclovir, trifluorothymidine and related compounds;
steroidal and nonsteroidal anti-inflammatory agents
illustratively flurbiprofen, ibuprofen, naproxen, indomethacin
and related compounds; anti-mitotic drugs illustratively
colchicine taxol and related compounds; drugs that act on actin
polymerization illustratively phalloidin, cytochlasin B and
related compounds; inhibitors of dihydropyrimidine
dehydrogenase (DPD), thymidine phosphorylase (TP) and/or
uridine phosphorylase (UP) enzyme inhibitors; ultraviolet light
(UV) filters illustratively benzophenone derivatives such as
oxybenzone, octocrylene, octyl methoxycinnamate, and
avobenzone; radiation proactive agents illustratively
methyluracils such as 6-methyluracil and 4-methyluracil; and
immunomodulating molecules such as tacrolimus, and
pimecrolimus. An active agent need not have pharmaceutical
activity. Other active agents are illustratively cosmetics such as
pigments, dyes, and fillers.
(Spec. 117).
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15. The Specification teaches:
Carriers are optionally volatile compounds such as volatile
silicones. The use of a volatile carrier allows application of the
active agent to the skin and is capable of evaporating so as to
leave a pleasing feel to the user. Among the many possible
carriers, the siloxanes offer excellent evaporation properties and
are preferred. Siloxanes are illustratively cyclic
organosiloxanes or non-cyclic organosiloxanes. Examples of
cyclic organosiloxanes illustratively include cyclic
polydiorganosiloxanes, cyclotetradimethicones and
cyclopentadimethicones. Linear organopolysiloxanes are
illustratively alkyl-, alkoxy- or phenyldimethicones, and alkyl-,
alkoxy- or phenyltrimethicones. Optionally, a carrier is an
aliphatic volatile organosiloxane. Aliphatic volatile
organosiloxanes optionally have from two to six silicon atoms.
Optionally, an aliphatic volatile organosiloxane is a linear
polyorganosiloxane such as a polyorganosiloxane with 2 to 6
silicon atoms, optionally, an organo- trisiloxane, disiloxane, or
combinations thereof. Disiloxane itself has a very rapid
evaporation profile on the skin. As such, it is optionally not
used [] as a carrier. Optionally, a carrier is ethyl trisiloxane. It
is appreciated that an inventive composition optionally includes
more than one carrier.
(Spec. 125).
16. The Specification teaches:
a vehicle includes a volatile high molecular weight hydrocarbon
such as linear or branched volatile hydrocarbons with 6 to 16
carbon atoms, alone, combined with a second or additional
vehicle with a lower boiling point, or combined with less than
5% of organic solvent of 5 carbons or fewer. The usefulness of
this vehicle type was also unexpected due to the inability of
such a vehicle to solubilize the active agent at low temperatures
such as 4°C for a sufficient period of time (i.e. 30 days). A
volatile high molecular weight hydrocarbon vehicle is linear or
branched and illustratively includes Cg-Ci6 alkanes, branched
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Cg-Ci6 esters, and mixtures thereof. Optionally, a volatile high
molecular weight hydrocarbon vehicle is linear or branched and
illustratively includes C10-C16 alkanes, branched C10-C16 esters,
and mixtures thereof. Illustrative examples of a volatile high
molecular weight hydrocarbon vehicle include isododecane,
methylpentadecene, and isohexadecane. Specific examples of a
volatile high molecular weight hydrocarbon vehicle include:
isododecane sold as Permethyl 99 A from Presperse (Somerset,
NJ); a combination of isododecane, hydrogenated
tetradecenyl/methylpentadecene sold as SMART-5 from
IMCD, The Netherlands; isohexadecane sold as Permethyl
101A from Presperse; the combination of Cl3-16 isoparaffin,
Cl2-14 isoparaffin, and Cl3-15 alkane sold as SiClone SR-5
from Presperse; the combination of coconut alkanes and coco-
caprylate/caprate sold as Vegelight 1214LC by Grant Industries
(Elmwood Park, NJ)
(Spec. 132).
17. The Specification teaches:
it was unexpectedly discovered that an organic polyhalogenic
vehicle alone or in combination with less than 5% low
molecular weight hydrocarbon organic solvent (6 carbons or
fewer), or particular volatile hydrocarbons in combination with
less than 5% low molecular weight hydrocarbon organic
solvent (6 carbons or fewer) could incorporate an active agent
such as a retinoid at appropriate therapeutic levels and reduce
the levels of low molecular weight hydrocarbon solvent to less
than 5 percent
(Spec. 129).
18. The Specification teaches that:
Organic polyhalogenic solvents are optionally those disclosed
in US Patent No: 6,251,375. In particular instances, vehicles
incorporate a halogen such as one or more fluorine atoms. A
vehicle is optionally a substituent containing C1-C20 alkyl,
alkenyl, or alkynl, any of which is cyclic, bicyclic, linear,
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Application 13/795,663
branched, or combinations thereof, wherein a substitutent [sic]
is a fluorine atom.
(Spec. 130).
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 Inti Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Mat417.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 5—12; FF 1—12) and agree that
the claims are rendered obvious by Harrison, Belsil RG 90, and Kulesza.
We address Appellant’s arguments below.
Prima Facie Obviousness
Appellant contends
the only composition taught by Harrison that includes a retinol
is the composition of Examples 13 and 14. Example 13 is the
only relevant example. Example 13 includes 0.3% of a retinol
as a solubilized 15% solution in caprylic/capric triglycerides
which is sold as the trade material RETINOL 15D. The
triglyceride in RETINOL 15D is an excellent solvent for
retinols due to the fatty characteristics of both materials . . .
This in no way suggests that the dimethicone can act as a
solvent for the retinoid. As is clearly taught by the
specification, retinoids are not fully soluble in disiloxane
(paragraph [0037]).
(App. Br. 5).
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We are not persuaded. Appellant acknowledges that the triglyceride
component in Harrison results in fully solubilized active agent, and due to
the use of “comprising” in claim 1, claim 1 reasonably encompasses the use
of Harrison’s triglyceride component. Thus, the person of ordinary skill,
following Harrison’s suggestion to form an active composition with retinol,
triglycerides, and “hexamethyldisiloxane [a disiloxane] and/or low
molecular weight dimethicones” (FF 3), would have reasonably expected the
resulting composition to have fully solubilized retinol as Appellant notes
that “RETINOL 15D is an excellent solvent for retinols” (App. Br. 5).
Appellant contends “that no teaching of BESIL suggests that adding
isododecane to the Harrison material will improve any property of Harrison,
and does not suggest that isododecane (which the instant specification
clearly teaches will not solubilize retinols) will impart any solubility to the
retinol” (App. Br. 6).
We find this argument regarding reason to include isododecane
unpersuasive because Belsil RG 90 specifically teaches a gel that “can be
added to the finished formulation,” and because it “provides a silky skin feel
combined with hydrophobic film forming properties” (FF 7). Belsil RG 90
even specifically identifies the benefits of isododecane itself within the
formulation, explaining the “evaporation of isododecane leaves a non-tacky
film which improves transfer- and water resistance of cosmetic
formulations” (FF 6). Lastly, Belsil RG 90 demonstrates the combinability
of isododecane and disiloxanes (hexamethylsiloxane as in Harrison) by
teaching an “elastomer gel [that] is a crosslinked high-molecular weight
organosiloxane polymer dispersed in isododecane” (FF 5). Thus, an
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ordinary artisan, interested in applying Harrison’s retinol compositions “that
provide a water resistant film . . . and are not greasy” (Ans. 7) but desiring
improved skin feel, would have had reason to incorporate the isododecane to
obtain a non-tacky film with a silky skin feel as suggested by Belsil RG 90
(FF 5-7).
Appellant contends “one of ordinary skill in the art has no motivation
to combine the ethyl trisiloxane of Kulesza into the compositions of
Harrison as no benefit is expected to be gained by the combination” (App.
Br. 6). Appellant contends “there is simply no benefit gained from the
substitution of ethyl trisiloxane for some of the low molecular weight
dimethicone of Example 13 of Harrison as an additional carrier for the
vitamin A” {id. at 7).
We find this argument unpersuasive because we agree with the
Examiner that “[combining prior art elements according to known methods
to yield predictable results is a proper rational to support a rejection under 35
U.S.C. § 103” (Ans. 8; cf. KSR, 550 U.S. at 416—17). While claim 1 requires
two silicone carriers, disiloxane and ethyl trisiloxane, Kulesza recognizes
that multiple carriers including ethyl trisiloxane may be used in retinoid
cosmetics (FF 8, 10), Harrison teaches disiloxane is another known carrier
that is “odorless, nontoxic, nongreasy and nonstinging . . . and exhibits]
enhanced spreadability and ease of application to the skin” (FF 4).
Therefore, improving Kulesza’s composition by combining the carrier of
Harrison represents the “combination of familiar elements according to
known methods [that] is likely to be obvious” KSR, 550 U.S. at 416.
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Appellant contends:
With the thousands of possible compounds known in the art, as
evidenced by Harrison alone, Appellant was faced with an
incredibly large number of combinatorial possibilities with no
guidance which combination would work, if any. In such
circumstances, the Examiner cannot succumb to hindsight
claims of obviousness.
(App. Br. 7).
Moreover, Example 13 of Harrison provides evidence of a working
solution (FF 1) as does Example 1 of Kulesza (FF 12) and the prior art
suggests that each of these components function in skin compositions (FF 1—
12). Therefore, while we are fully aware that hindsight bias may plague
determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36
(1966), we are also mindful that the Supreme Court has clearly stated that
the “combination of familiar elements according to known methods is likely
to be obvious when it does no more than yield predictable results.” KSR, 550
U.S. at 416.
Unexpected Results
Appellant contends
The unexpected result of achieving full solubility of an
active by combining three agents, each of which the active not
fully soluble in, represents a point that fully merits patentability
and the claim scope is fully in line with the unexpected result.
The claims recite three specific solvents, ethyl trisiloxane,
disiloxane, and isododecane. The claims recite that the active is
fully solubilized when the solvents are combined. As such, the
claims clearly are tailored to the unexpected result.
(App. Br. 8).
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We find this argument unpersuasive for a number of reasons. First,
the argument is inconsistent with the Specification itself, which identifies the
combination of components with an organic polyhalogenic vehicle as
unexpected (FF 17), not the three specific solvents listed in claim 1 which do
not ordinarily contain halogen atoms (and Appellant separately discusses
polyhalogens in the Specification) (FF 18). Thus, the claims are not
commensurate in scope with the result asserted in the Specification.
Unexpected results must be “commensurate in scope with the degree of
protection sought by the claimed subject matter.” In re Harris, 409 F.3d
1339, 1344 (Fed. Cir. 2005).
Second, Appellant provides no evidence showing that an unexpected
result occurs for the particular combination of components in claim 1.
Indeed, none of the examples in the Specification appear to comprise the
claimed elements (see Spec. ]Hf 62—75), and Appellant does not point to a
specific example as supporting the unexpected results. See In re Soni, 54
F.3d 746, 750 (Fed. Cir. 1995) (“It is well settled that unexpected results
must be established by factual evidence. Mere argument or conclusory
statements . . . [do] not suffice.”).
Third, Appellant provides no comparison to the closest prior art of
either Harrison or Kulesza demonstrating that the result is, in fact,
unexpected. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir.
1991) (“[W]hen unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.”).
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Lastly, given the disclosure of Harrison that the retinol composition is
optically clear, and therefore dissolved the retinol (FF 4) and Kulesza’s
teaching of stable solutions (FF 11), the combination of the known
components disclosed by Harrison, Kulesza, and Belsil RG 90 would have
reasonably been expected to result in a dissolved active retinol agent. See In
re Skoner, 517 F.2d 947, 950 (CCPA 1975) (“Expected beneficial results are
evidence of obviousness of a claimed invention.”).
Therefore, we find the evidence of record, as balanced with
Appellant’s assertion, without evidence, of unexpected results, supports the
Examiner’s finding that claim 1 was obvious over Harrison, BELSIL RG 90,
and Kulesza.
Conclusion of Law
(i) The evidence of record supports the Examiner’s conclusion that
Harrison, BELSIL RG 90, and Kulesza render claim 1 obvious.
(ii) Appellant has not presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness.
B. Provisional Obviousness-type Double Patenting
We decline to reach this provisional rejection because the claims
currently pending in the related case, US 13/685,244 have been significantly
amended relative to the claims pending at the time of the Examiner’s Final
Office Action on July 29, 2015, and the analysis may no longer necessarily
be reflective of the claims as pending in US 13/685,244. See Ex parte
Moncla, 95 USPQ2d 1884 (BPAI 2010) (precedential). The rejection is
provisional; accordingly, the issues are not ripe for decision.
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SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over Harrison, Belsil RG 90, and Kulesza. Claims 2—7,
16, 17, and 23 fall with claim 1.
We decline to address the provisional obviousness-type double
patenting rejection.
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
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