Ex Parte Masini-Eteve et al

Patent Trial and Appeal Board

Sep 6, 2016

13317113 (P.T.A.B. Sep. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/317, 113 10/11/2011 Valerie Masini-Eteve
22428 7590 09/08/2016
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
088734-0164 3422
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
09/08/2016 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VALERIE MASINI-ETEVE and BRIGITTE TARA VELLA
Appeal2015-007584
Application 13/317, 113
Technology Center 1600
Before DONALD E. ADAMS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 67----69, 73, 74,
and 78-86 (App. Br. 16-17).2 Examiner entered rejections under 35 U.S.C.
§ 103(a) and obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify "[t]he real party in interest [as] the assignee, Besins
Healthcare Luxembourg SARL" (App. Br. 3).
2 Pending claims 87-89 stand withdrawn from consideration (see Final
Action (Final Act.) (Office Action Summary: Disposition of Claims).
Appeal2015-007584
Application 13/317, 113
STATEMENT OF THE CASE
Appellants' "invention relates to a pharmaceutical composition in the
form of a gel or a solution based on dihydrotestosterone (DHT)" (Spec. 1:
11-12). Claim 67 is representative and reproduced below:
Pharmaceutical composition for the transdermal delivery
of [DHT] for systemic absorption in the form of a gel or a
solution, comprising from 0.2% to 1.5% [DHT], from about
0.2% to about 3% isopropyl myristate, and from about 50% to
about 7 5% ethanol, these percentages being expressed by
weight based on the weight of the composition.
(App. Br. 16: Appellants' Claim 67.)
REJECTIONS OF RECORD
Claims 67----69, 73, 74, and 78-86 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination ofWang3 and Kochinke. 4
Claims 67----69, 73, 74, and 78-86 stand rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1-32 of Taravella. 5
Claims 67----69, 73, 74, and 78-86 stand provisionally rejected under
the judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 23--41 of Masini- Masini-Eteve. 6
3 C. Wang et al., Comparative Pharmacokinetics of Three Doses of
Percutaneous Dihydrotestosterone Gel in Healthy Elderly Men-A Clinical
Research Center Study, 83 Journal of Clinical Endocrinology and
Metabolism 2749-2757 (1998).
4 Kochinke et al., US 5,613,958, issued Mar. 25, 1997.
5 Taravella et al., US 7,611,727 B2, issued Nov. 3, 2009.
6 Masini-[Eteve] et al., US 2011/0098258 Al, published Apr. 28, 2011
(Application No. 12/912,310).
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Application 13/317, 113
Clarification:
Examiner's Answer states that "[e]very ground of rejection set forth in
the [Final] Office [A ]ction dated July 16, 2014 from which the appeal is
taken is being maintained by the examiner except for the grounds of
rejection (if any) listed under the subheading 'WITHDRAWN
REJECTIONS"' (Ans. 2). A "WITHDRAWN REJECTIONS" subheading,
however, does not appear in Examiner's Answer. Therefore, the foregoing
statements, set forth in Examiner's Answer, when coupled with Examiner's
December 9, 2014 post-Final Communication, introduce the following
ambiguities in this record, which we resolve in tum:
I
Examiner's Answer makes reference to a rejection of claims 67-69,
73, 74, and 78-86 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Wang and van der Hoop7 (see Ans. 2-3 and 8-9). As
Appellants explain, however, Examiner withdrew this rejection in a
December 9, 2014 post-Final Office Communication (see Reply Br. 2; see
Examiner's December 9, 2014 post-Final Office Communication 2: i-f 3 (the
rejection over the combination of Wang and van der Hoop "is herewith
withdrawn"); see also July 28, 2015 Applicant-Initiated Interview Summary;
July 22, 2015 Office Communication). Therefore, we find that Examiner's
reference to this rejection at pages 2-3 of Examiner Answer is in error. The
rejection over the combination of Wang and van der Hoop was withdrawn
by Examiner and, therefore, is not before this panel for review.
7 Van der Hoop, US 2003/0027804 Al, published Feb. 6, 2003. Examiner
asserts that this reference was previously referred to, on this record, as "Von
Kleinsorgen" (Ans. 2).
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Application 13/317, 113
II
Examiner's December 9, 2014 post-Final Office Communication
states that a rejection of claims 67-77 over the combination of Wang, Klein,
Hoang, 8 and Sun9 "is herewith withdrawn in part" (see Examiner's
December 9, 2014 post-Final Office Communication 2: i-f 2). In this regard,
"Examiner maintains that the Wang ... reference is still applicable and used
in the modified rejections. Therefore, the rejection is herewith withdrawn in
part" (id.; see also Ans. 12).
We interpret Examiner's assertions to mean that Wang is a relevant
reference as it is applied in combination with Kochinke. Wherein, the
rejection over the combination of Wang, Klein, Hoang, and Sun is
withdrawn (see id.; see also Reply Br. 2 (Examiner's "list of rejections set
forth at pages 8-9 of the Examiner's Answer does not include the previous
rejection over Wang in view of Klein, Hoang, and Sun, which Appellant[s]
believe[] was withdrawn")).
Our interpretation of Examiner's intent is further bolstered by
Examiner's failure to rebut Appellants' arguments with respect to this
rejection (see App. Br. 12-14; cf Ans. 1-14; see Ans. 8). Nevertheless, to
the extent that any confusion remains with regard to the status of this
rejection, for the foregoing reasons, as well as those set forth by Appellants,
we reverse, and will not further discuss, the rejection over the combination
of Wang, Klein, Hoang, and Sun (see App. Br. 12-14).
8 Hoang et al., US 5,922,314, issued July 13, 1999.
9 Sun et al., US 6,231,875 Bl, issued May 15, 2001.
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Application 13/317, 113
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Wang discloses a "DHT gel ... formulated as a 0.7% hydroalcoholic
gel," wherein "[t]he gel excipients included carbomer, triethanolamine,
isopropyl myristate, absolute ethanol, and purified water," which are
"components [] commonly used in the cosmetic industry" (Wang 2750: col.
2, 1---6; Ans. 4 and 10).
FF 2. Examiner finds that Wang "fails to specifically teach the amounts of
isopropyl myristate, absolute ethanol, gelling agent, and the ratios claimed"
by Appellants (Ans. 4).
FF 3. Kochinke "relates to the transdermal delivery of drugs" (Kochinke 1:
12-13).
FF 4. Kochinke exemplifies a "fill solution of [the tolerance-inducing drug
[] isosorbide dinitrate,] ISDN[,] (USP, 1.0 wt%), anhydrous ethanol (USP,
65.9 wt%), water (3.25 wt%), and isopropyl myristate (2.0 wt%)"
(Kochinke 18: 2--4; Ans. 4; see Ans. 11).
FF 5. Masini-Eteve declares that the results of a study using two
compositions that are "comparable with respect to their components and the
relative amounts thereof, other than the presence of testosterone in [one
composition and] DHT" in the other establish that "one cannot simply
replace the DHT or testosterone in a given pharmaceutical composition with
testosterone or DHT, respectively, and expect to obtain a pharmaceutically
acceptable composition that will be suitable for transdermal delivery"
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(Dec. 10 ilil 4--5; see id. il 4 ("the DHT composition retains its pharmaceutical
activity, does not exhibit precipitation, phase separation, or degradation"
after storage "for 2 years ... at 25 °C[,] for 6 months when stored at 40 °C
... [and] for 25 months ... at 4 °C," whereas "[t]he testosterone
composition ... exhibited precipitation after storage at + 4 °C for one
night)).
ANALYSIS
Based on the combination of Wang and Kochinke, Examiner
concludes that, at the time Appellants' invention was made, it would have
been prima facie obvious to use the weight percentages of ethanol, water and
isopropyl myristate suggested by Kochinke in Wang's DHT gel (see Ans. 4).
Stated differently, Examiner relies on Kochinke not to suggest the
interchangeability of DHT with another active agent, but instead to suggest
the concentration ranges a person of ordinary skill in this art would find
obvious in the formulation of Wang's DHT gel, which includes ingredients
that are conventionally used in the cosmetic industry, such as isopropyl
myristate, absolute ethanol, and purified water (see Ans. 10-11; FF 1). In
this regard, Examiner finds that "[t]he determination of optimal or workable
concentration[ s] of the gel excipients by routine experimentation is obvious
absent [a] showing of criticality of the claimed concentration[s]" (Ans. 4 and
10). In re Aller, 220 F.2d 454, 456 (CCPA 1955), ("[I]t is not inventive to
discover the optimum or workable ranges by routine experimentation.").
Appellants contend that Kochinke fails to make up for the Wang's
failure to suggest concentration ranges for the components of Wang's DHT
gel, because "Kochinke does not disclose any [DHT] formulations at all, and
10 Declaration of Valerie Masini-Eteve, executed Nov. 28, 2006.
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so it provides no suggestion that the [] amounts of isopropyl myristate or
ethanol [set forth in Appellants' claims] would be effective for the
transdermal delivery of' DHT (App. Br. 8). In this regard, Appellants
contend that "the evidence of record shows that formulating specific active
agents in pharmaceutical compositions for transdermal delivery involves a
high level of unpredictability, and the suitability of a given formulation can
be active agent specific ... even for compounds with structural similarities,
such as [DHT] and testosterone" (id. 8-9; see FF 5).
Based on the foregoing, Appellants contend that Wang's DHT and
Kochinke' s "ISDN are structurally dissimilar compounds with different
physical, chemical, and physiological properties, and so there would have
been no reasonable expectation that a composition suitable for the
transdermal delivery of ISDN would be effective for the transdermal
delivery of [DHT]" (App. Br. 9). Stated differently, we recognize that the
formulations disclosed by Wang and Kochinke both contain "components []
commonly used in the cosmetic industry" (see FF 1 and 4; cf FF 5; App. Br.
8-10). This, however, is not the end of the story. To the contrary,
Appellants' declaratory evidence must be considered as part of the
obviousness analysis (see FF 5). For the following reasons, we find that
when Wang and Kochinke are viewed in light of Appellants' declaratory
evidence Examiner failed to establish an evidentiary basis on this record to
support a conclusion that a person of ordinary skill in this art would have
reasonably expected that the percentages disclosed by Kochinke for each
component of a formulation, comprising ISDN, could have been routinely
optimized to arrive at, or would have been remotely similar to, the
percentages necessary to achieve a successful formulation for the
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Application 13/317, 113
transdermal delivery of DHT, as required by Appellants' claimed invention
(see FF 1 and 4; cf FF 5; App. Br. 8-10).
Appellants' declaratory evidence establishes that a person of ordinary
skill in this art would not have reasonably expected the successful
formulation of a composition, in the form of a gel or solution, comprising
DHT, ethanol, isopropyl myristate, and water, at the percentages required by
Appellants' claimed invention, based on Kochinke' s disclosure of the
formulation of an unrelated active agent. In the absence of a reasonable
expectation of success one is left with only an "obvious to try" situation
which is not the standard of obviousness. See In re 0 'Farrell, 853 F.2d 894,
903 (Fed. Cir. 1988) (obviousness requires a "reasonable expectation of
success"). Stated differently, it is not obvious, as here, to: "vary all
parameters or try each of numerous possible choices until one possibly
arrived at a successful result, where the prior art gave either no indication of
which parameters were critical or no direction as to which of many possible
choices is likely to be successful" or "explore a new technology or general
approach that seemed to be a promising field of experimentation, where the
prior art gave only general guidance as to the particular form of the claimed
invention or how to achieve it." Id.
For the foregoing reasons, we find that Examiner failed to establish a
prima facie case of obviousness. Therefore, we do not consider Appellants'
contentions relating to the unexpected properties of their claimed invention
(App. Br. 10-12).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness.
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Application 13/317, 113
The rejection of claims 67-69, 73, 74, and 78-86 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Wang and Kochinke is
reversed.
Obviousness-type Double Patenting:
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
FACTUAL FINDINGS (FF)
FF 6. Travella's claim 1 is reproduced below:
1. A pharmaceutical composition for transdermal or transmucous
administration of at least one active substance, comprising
an active substance,
a fatty acid percutaneous absorption promoter in an amount of
between 0.1 % and 20%, these percentages being expressed on
a weight basis relative to 100 g of pharmaceutical
composition,
an alcoholic vehicle comprising an alcohol selected from the
group consisting of ethanol and isopropanol, and
a stabilizer capable of stabilizing the fatty acid in said
pharmaceutical composition, wherein said stabilizer
comprises the fatty acid ester of said fatty acid and said
alcohol and is present in an amount of between 0.1 % and
10%, these percentages being expressed on a weight basis
relative to 100 g of pharmaceutical composition and
wherein said compositions is in the form of a gel or solution,
and
wherein the amount of said fatty acid percutaneous absorption
promoter does not vary by more than +/- 5% after storage for
6 months at 40°C and 75% relative humidity.
(Taravella 15: 27--49 (claim 1); see Ans. 6-7.)
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FF 7. Taravella defines "active substance(s) present in the pharmaceutical
composition according to the invention may advantageously be ... [DHT],"
wherein "[t]he active substance content is advantageously between 0.01 %
and 5%, these percentages being expressed on a weight basis relative to
lOOg of pharmaceutical composition" (Taravella 4: 50-5: 1; see Ans. 6-7).
FF 8. Taravella's claim 4 is drawn to "[a] pharmaceutical composition
according to claim 1, wherein the fatty acid ester is selected from the group
consisting of[, inter alia,] isopropyl myristate" (Taravella 15: 57-61; see
Ans. 6-7).
FF 9. Taravella's claim 6 is drawn to "[a] pharmaceutical composition
according to claim 1, having an alcoholic vehicle content of between 10%
and 90%, these percentages being expressed on a weight basis relative to
100 g of pharmaceutical composition" (Taravella 15: 64--67; see Ans. 6-7).
ANALYSIS
The obviousness-type double patenting rejection over Taravella:
Appellants' claim 67 is drawn to a "[p ]harmaceutical composition for
the transdermal delivery of [DHT] for systemic absorption in the form of a
gel or a solution" (see Appellants' claim 67). Taravella's claim 1 is drawn
to "[a] pharmaceutical composition for transdermal or transmucous
administration of at least one active substance," such as DHT, wherein the
composition is in the form of a gel or solution (FF 6 and 7).
The pharmaceutical composition of Appellants' claim 67 "compris[es]
from 0.2% to 1.5% [DHT]" (see Appellants' claim 67). The pharmaceutical
composition of Taravella' s claim 1 comprises "between 0.01 % and 5%"
DHT (FF 6 and 7). 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
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Application 13/317, 113
art, and the claimed invention falls within that range, there is a presumption
of obviousness.").
The pharmaceutical composition of Appellants' claim 67 comprises
"from about 0.2% to about 3% isopropyl myristate" (see Appellants' claim
67). The pharmaceutical composition of Taravella' s claim 1 comprises a
"fatty acid ester," such as, isopropyl myristate "in an amount of between
0.1%and10%" (see FF 6 and 8). Iron Grip Barbell Co. v. USA Sports, Inc.,
392 F.3d at 1322.
The pharmaceutical composition of Appellants' claim 67 comprises
"from about 50% to about 75% ethanol" (see Appellants' claim 67). The
pharmaceutical composition of Taravella's claim 1 comprises ethanol in the
range of, at least, between 10% and 90% (FF 6 and 9). Iron Grip Barbell
Co. v. USA Sports, Inc., 392 F.3d at 1322.
The percentages in Appellants' claim 67 and Taravella's claim 1 are
expressed by weight based on the weight of the composition (see
Appellants' claim 1; cf FF 6, 7, and 9).
In sum, Taravella's claimed invention makes obvious the subject
matter of Appellants' claim 67 (see Ans. 6-7 and 13). Therefore, we
recognize, but are not persuaded by, Appellants' contention that "no claim of
[Taravella] renders obvious the specific DHT compositions recited in the
instant claims" (App. Br. 14). Further, Appellants' claim 67 makes use of
the open, non-exclusive, transitional phrase: "comprising" (see Appellants'
claim 67). Therefore, we recognize but are not persuaded by Appellants'
contention that Appellants' claims "do not suggest the compositions recited
in [Taravella ], which include other components and features" (App. Br. 14;
see Reply Br. 5). We recognize, but are not persuaded by, Appellants'
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Application 13/317, 113
contention that Taravella's Specification cannot be used as a dictionary to
define the terms of Taravella' s claimed invention (see Reply Br. 5). See Sun
Pharmaceutical Industries, Ltd. V. Eli Lilly and Co., 611F.3d1381, 1387
(Fed. Cir. 2010), citing In re Basel! Poliolefine Italia S.P.A., 547 F.3d 1371,
1378 (Fed. Cir. 2008), ("the specification's disclosure may be used to
determine whether a claim 'merely define[ s] an obvious variation of what is
earlier disclosed and claimed,' 'to learn the meaning of [claim] terms,' and
to 'interpret []the coverage of [a] claim"').
The provisional obviousness-type double patenting rejection over Masini-
Eteve:
Based on Masini-Eteve, Examiner concludes that "[a]lthough the
conflicting claims are not identical, they are not patentabily discinct from
each other" (Ans. 7; see id. at 7-8).
For the reasons set forth above, the provisional obviousness-type
double patenting rejection over Masini-Eteve is not "the only rejection
remaining" in the Application, which is the subject of this Appeal.
Therefore, we are not persuaded by Appellants' contention that this
provisional rejection should be withdrawn (App. Br. 14; see Reply Br. 6).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness-type double patenting.
The rejection of claim 67 under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-32
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of Taravella is affirmed. Claims 68, 69, 73, 74, and 78-86 are not separately
argued and fall with claim 67.
The rejection of claim 67 stand provisionally rejected under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over claims 23--41 of Masini-Eteve. Claims 68, 69, 73, 74, and
78-86 are not separately argued and fall with claim 67.
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
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