Ex Parte CLARK et al

Patent Trial and Appeal Board

Jun 7, 2018

13155965 (P.T.A.B. Jun. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/155,965 06/08/2011
90434 7590 06/11/2018
Glaxo Smith Kline
c/o NATH, GOLDBERG & MEYER
112 South West St.
Alexandria, VA 22314-2825
FIRST NAMED INVENTOR
Kathleen L. CLARK
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
26655A 4066
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
06/11/2018 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):
3 g876j9ydo9fd6n@jetable.net
jgoldberg@nathlaw.com
USPTO@nathlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KATHLEEN L. CLARK and JOANNE M. FRASER
Appeal2017-000243
Application 13/155,965
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and DAVID COTTA,
Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellants 1 appeal from Examiner's
decision to reject claims as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Claims 1, 3, 9, 14--1 7, and 24 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows:
1 Appellants identify the real party in interest as STIEFEL RESEARCH
AUSTRALIA PTY LTD, a subsidiary of GlaxoSmithKline plc. Appeal Br.
3.
Appeal2017-000243
Application 13/155,965
1. A method for treating pruritus in a patient comprising
administering to a patient suffering from pruritus a first topical
composition that is a lotion consisting essentially of pramoxine
or a pharmaceutically acceptable salt thereof in an amount from
about 0.1 to about 5% by weight, at least one occlusive skin
conditioning agent in an amount from about 1 to about 10% by
weight,
an organosiloxane in an amount from about 0.5 to about
5% by weight,
an emulsifier in an amount from about 0.5 to about 10%
by weight,
a gelling agent selected from the group consisting of gum
arabic, gum tragacanth, locust beam gum, guar gum, xanthan
gum, and carbomer, in an amount of about 0.1 to about 2% by
weight,
an emollient in an amount of about 0.01 to about 5% by
weight,
and an aqueous solvent in an amount from about 60 to
about 90% by weight,
wherein the administration of said first composition
provides a more effective treatment of said pruritus in
comparison to treatment of pruritus achieved by administration
of a second topical composition comprising about 1 % by
weight hydrocortisone.
Appellants request review of the following rejections made by
Examiner:
I. Claims 1, 3, 14--17, and 28 under 35 U.S.C. § 103(a) as unpatentable
over Yosipovitch2 in view of De Oliveira3 and Clemente. 4
2 Y osipovitch and Maibach, Effect of topical pramoxine on experimentally
induced pruritus in humans, 37 J. Am. Acad. Denn. 278-280 (1997)
("Y osipovitch").
3 De Oliveira, US 2005/0152993 Al, publ. July 14, 2005 ("De Oliveira").
4 Clemente et al., US 5,576,346, issued Nov. 19.1996 ("Clemente").
2
Appeal2017-000243
Application 13/155,965
II. Claims 9 and 24 under 35 U.S.C. § 103(a) as unpatentable over
Y osipovitch in view of De Oliveira and Clemente and further in view
of Kagayama. 5
I. Obviousness over Yosipovitch, De Oliveira, and Clemente
Examiner finds that the Yosipovitch teaches the anti-pruritic action of
1 % pramoxine in a vehicle. Final Act. 5 6. Examiner acknowledges that the
vehicle (a hydrophilic base) is not described in Y osipovitch. Id. Therefore,
it is not apparent whether Yosipovitch's lotion includes an "occlusive skin
conditioning agent petrolatum, an organosiloxane, an emulsifier, or the
gelling agents as claimed." Id. Examiner looks to De Oliveira and
Clemente for these limitations. See id. at 5---6. Examiner concludes that "[i]t
would have been obvious to one of skill in the art at the time of the invention
to incorporate a silicone oil such as dimethicone ( organosiloxane) or an
emulsifier and occlusive skin conditioning agent or the carbomer into the
composition useful in treating pruritus." Id. at 6. Examiner reasons that
"[p ]roducts of identical chemical composition can not have mutually
exclusive properties," therefore, the effect of treating pruritus based on the
combined formulation when comparing to a corticosteroid would have the
claimed effect. See id. at 7.
Appellants contend that "Yosipovitch used a ready-made 1 %
pramoxine lotion product, with all the ingredients already selected and
included in the formulation." Appeal Br. 15. Y osipovitch obtained the test
product from Ferndale laboratories and this product "includes povidone -
5 Kagayama et al., US 5,939,427, issued Aug. 17, 1999 ("Kagayama").
6 Final Office Action mailed September 24, 2015 ("Final Act.").
3
Appeal2017-000243
Application 13/155,965
the same potentiate used in De Salva. 7" Id. "The claimed methods, reciting
the 'consisting essentially of' transition phrase with respect to the required
lotion, also effectively precluded inclusion of any additional ingredients that
materially affect the basic and novel characteristics of the formulation as it is
used to treat pruritus." Id. at 8. In other words, Appellants position is that
Y osipovitch includes povidone in the formulation, which is not
encompassed by the claim.
The issue is: Does the evidence of record support the Examiner's
conclusion that the method of treating itchy skin would have been obvious?
Findings of Fact
FF 1. Y osipovitch teaches testing the "effect on itching and thermal
sensation where pramoxine 1 % lotion (F emdale laboratories F emdale
Michigan.) and its vehicle (a hydrophilic base)" is applied to the upper
forearm of test subjects. Y osipovitch 278. "This study demonstrated
that both the magnitude and duration of histamine-induced itch for
reduced by pramoxine." Id. at 280.
FF2. De Oliveira teaches compositions for treating skin ailments including
dry itchy scaly skin. De Oliveira, i-fi-12--4, 5, 11, 18, see claim 1.
Ingredients in the body wash taught in De Oliveira include water as an
inert ingredient as well as carbomer as a gelling agent at a
concentration from 0.9-1.1 %. Id. i-f 12. Skin creams contain water as
an inert ingredient, 3.6--4.4 % propylene glycol as a cleaner, 2.7-3.3%
mineral oil as an oil base, 3.6--4.4% carbomer as a gelling agent,
7 De Salva and Migliarese, US 3,172,805, issued Mar. 9. 1965 ("De Salva").
4
Appeal2017-000243
Application 13/155,965
0.45---0.55% dimethicone as a luster agent, and 0.9-1.1 % petrolatum
as an emollient among other ingredients. See id. i-f 1 7.
FF3. Clemente teaches oil and water emulsions containing an emulsifying
wax. Clemente 7: 1 to 8:20.
FF4. De Salva teaches using local anesthetics to treat pruritus, also known
as itchy skin. See De Salva 1: 17-19. De Salva "found that certain
materials have a surprising effect upon certain local anesthetics ....
The combination of these materials with the anesthetic resulted in a
'potentiation' of the latter." Id. at 1:35-39. "'Potentiation" denotes
the 'intensification' of the drug effect." Id. at 1:33-34.
FF5. De Salva teaches combining pramoxine and PVP (polyvinyl
pyrolidone). Id. at 4:8. "For example, where a 1:1 ratio ofpramoxine
and PVP is employed, a combined concentration of the two
ingredients, i.e. pramoxine and PVP, of .4%, will accomplish an
anesthetic effect greater than that of a .4% concentration of the drug
alone." Id. at 4:6-11, see also 6:33-62, example 5 (formulation
containing pramoxine HCl at 1 % and PVP K 60 at 1 %). De Salva
also teaches potentiation of pramoxine HCl at a 0.2% aqueous
solution in combination with various potentiometers including PVP K
60 at a concentration ranging from 0.4% to 0.8%. See Id. at 5:50-63,
example 2.
FF6. Remington8 teaches that povidone can act as a gelling agent.
8 Remington: The Science and Practice of Pharmacy, Lippincott Williams
& Wilkins, editors David B. Troy and Paul Beringer, 771 (2006).
5
Appeal2017-000243
Application 13/155,965
FF7. Femadale's Prax®Lotion product label9 teaches that the active
ingredient is pramoxine HCl at a concentration of 1 % W /W and
functions as a local anesthetic. The product label also lists
"povidone" among the inactive ingredients.
Principle of Law
"An examiner bears the initial burden of presenting a prima facie case
of obviousness." In re Huai-Hung Kao, 639 F.3d 1057, 1066 (Fed. Cir.
2011).
Analysis
Y osipovitch teaches that a 1 % pramoxine lotion reduced histamine
induced itching. FF 1. De Oliveira also teaches treating skin ailments such
as itchy skin using formulations containing carbomer, propylene glycol,
mineral oil, dimethicone, and petrolatum among other ingredients. FF2.
Clemente teaches oil and water emulsions that contain emulsifying wax.
FF3. Examiner acknowledges that none of the references teach all the
elements as required by the claim. But, the Examiner finds that it would
have, nevertheless, been "obvious to one of skill in the art at the time of the
invention to incorporate a silicone oil such as dimethicone ( organosiloxane)
or an emulsifier and occlusive skin conditioning agent or carbomer into the
composition useful [for] treating pruritus" as disclosed in the Y osipovitch.
Final Act. 6. The Examiner finds that motivation for this combination
comes from the teaching of the Clemente, specifically, citing "that the
silicone oil such as [the] dimethicone or emulsifier impart an appropriate
9 Prax®Lotion (Pramoxine HCl 1 %), NDC 0496-07 48-03, Ferndale
Laboratories.
6
Appeal2017-000243
Application 13/155,965
creamy feel to the composition upon the skin and tend to form an oleaginous
layer over the treated pertussis lesion." Id.
Appellants contend that the claims exclude any ingredient "that acts or
may act as a ... potentiator of the pramoxine treating agent." Appeal Br.
11. We agree.
Claim 1 is directed to method of treating pruritus by administering to
a patient a topical lotion "consisting essentially of pramoxine or a
pharmaceutically acceptable salt thereof' in conjunction with at least one
occlusive skin conditioning agent, an organosiloxane, an emulsifier, a
gelling agent, an emollient, all in an aqueous solvent.
"By using the term 'consisting essentially of,' the drafter signals that
the invention necessarily includes the listed ingredients and is open to
unlisted ingredients that do not materially affect the basic and novel
properties of the invention." PPG Indus. v. Guardian Indus. Corp, 156 F.3d
1351, 1354 (Fed. Cir. 1998); see also In re Janakirama-Rao, 317 F.2d 951,
954 (CCP A 1963) ("opens the claims to the inclusion of ingredients which
would not materially affect the basic and novel characteristics of appellant's
compositions as defined in the balance of the claim.").
The claim makes clear that the active ingredient - pramoxine - is
required. The "consisting essentially of pramoxine" claim language
precludes the addition of ingredients that materially affect the active
ingredient pramoxine. We agree with Appellants that additional treating
agents as well as materials that have an affect on pramoxine are excluded
from the claim. See Appeal Br. 8-9.
Appellants direct our attention to the product label describing the
commercially available product used in Y osipovitch' s studies. Appeal
7
Appeal2017-000243
Application 13/155,965
Br. 10; FFl, FF7. Appellants next direct us to evidence in De Salva
establishing that povidone increases the anesthetic effect of pramoxine.
FF4-FF5. We agree with Appellants that De Salva establishes that the
combination of pramoxine with povidone (PVP) shows an increase in the
anesthetic effect of pramoxine. FF5. As such, we agree with Appellants
that the inclusion of povidone in a formulation that contains pramoxine
would have a material affect on pramoxine the active ingredient.
Examiner counter-argues that Remington teaches that povidone can
act as a gelling agent. Answer 8; FF6. We are not persuaded by Examiner's
rationale. Just because povidone is also known as a gelling agent does not
mean one should disregard the potentiation affect povidone has on
pramoxine. See FF4--FF5. Additionally, this rationale ignores the plain
language of the claim that provides a limited list of acceptable gelling agents
that notably does not include povidone. We agree with Appellants that the
evidence of record suggests that povidone potentiates the activity of
pramoxine and thereby is excluded from the claim because the De Salva
establishes that povidone has a material affect on the activity of pramoxine.
Examiner further counter-argues that "the drug insert clearly states
[that] the excipient list including the povidone art INACTIVE
INGREDIENTS." Ans. 8. Just because the drug insert lists povidone as an
inactive ingredient does not mean that the disclosure of De Salva can be
ignored. Here, De Salva establishes that povidone potentiates the activity of
pramoxine. FF4-FF5. Because the Examiner has not provide persuasive
evidence discrediting the teaching of De Salva, or established a reason why
one of ordinary skill in the art would have removed povidone from the
formulation suggested by the combination of references, we find that the
8
Appeal2017-000243
Application 13/155,965
Examiner has not sufficiently established that the claims are rendered
obvious.
We conclude that the preponderance of the evidence of record does
not support the Examiner's conclusion that the combination of Y osipovitch,
De Oliveira, and Clemente teaches a method having all limitations of
independent claim 1 and any dependent claims thereto. We, thus, reverse
the rejections under 35 U.S.C. § 103(a) that relies on this combination of
references.
II. Obviousness over Yosipovitch, De Oliveira, Clemente, and Kagayama
In rejecting claims 9 and 24 as obvious Examiner relies on
Y osipovitch, De Oliveira, and Clemente as evidence that the claimed
method of independent claim 1 would have been obvious. For the reasons
discussed above (see I.) we disagree with the Examiner's conclusion with
respect to claim 1. Because the Examiner has not directed us to any teaching
in Kagayama that remedies the deficiencies of the combination Y osipovitch,
De Oliveira, Clemente, discussed above, we do not find that the Examiner
has established a prima facie case of obviousness. We reverse this rejection.
SUMMARY
We reverse the rejection of all claims.
REVERSED
9