Ex Parte Duggins et al

Patent Trial and Appeal Board

Feb 27, 2017

13370505 (P.T.A.B. Feb. 27, 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.
13/370,505 02/10/2012 Donna Walker Duggins N64138 1040US.1 (0008.9) 2878
26158 7590 03/01/2017
WOMBLE CARLYLE SANDRIDGE & RICE, LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
EXAMINER
TCHERKASSKAYA, OLGA V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
03/01/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DONNA WALKER DUGGINS, JOHN-PAUL MUA,
DARRELL EUGENE HOLTON JR., and DANIEL VERDIN CANTRELL
Appeal 2015-008064
Application 13/370,505
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134(a) involves claims 1—15 and 26
(App. Br. 2).2 Examiner entered a rejection under 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellants’ disclosure “relates to compositions that contain nicotine,
and in particular, to nicotine-containing pharmaceutical compositions
1 Appellants identify the real party in interest as “Niconovum USA, Inc.”
(App. Br. 1.)
2 Pending claims 16—25 and 27—32 stand withdrawn from consideration
(App. Br. 2).
Appeal 2015-008064
Application 13/370,505
intended to be administered to provide a pharmacological effect, or
otherwise used for therapeutic purposes” (Spec. 2-4). Claim 1 is
representative and reproduced below:
1. A multi-layered pharmaceutical composition comprising two
or more formulations having different organoleptic properties,
wherein the formulations are selected from the group consisting
of:
i) a translucent, dissolvable formulation comprising a
sugar substitute in an amount of at least about 80% by weight
and a sugar alcohol syrup in an amount of from about 0.1% to
about 2% by weight, wherein the sugar substitute is a non-
hygroscopic sugar alcohol capable of forming a glassy matrix;
ii) a meltable formulation comprising a lipid having a
melting point of about 36 °C to about 45 °C;
wherein at least one formulation further comprises one or
more nicotinic compounds.
(App. Br. 20 (modified to correspond to Appellants’ elected invention (see
Appellants’ January 17, 2013 “RESPONSE TO RESTRICTION
REQUIREMENT”)).) We limit the scope of our review to Appellants’
elected invention. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI
1987).
The claims stand rejected as follows:
Claims 1—15 and 26 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Luber,3 Anderson,4 and Dam.5
3 Luber et al., US 2011/0318411 Al, published Dec. 29, 2011.
4 Andersson et al., US 2008/0286340 Al, published Nov. 20, 2008.
5 Dam et al., US 2007/0081949 Al, published Apr. 12, 2007.
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Application 13/370,505
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Luber discloses:
[A] tablet containing a first layer and a second layer, wherein:
(1) the first layer includes a pharmaceutically active agent and
the composition of the first layer is different from the
composition of the second layer; (ii) the tablet has a density less
than about 0.8 g/cc; and (iii) the tablet disintegrates in the
mouth when placed on the tongue in less than about 30 seconds.
(Luber | 6; see id. Tflf 131—133, 141, 147, and 149; see Final Act.6 2—3.)
FF 2. Luber’s “tablet is manufactured by compacting a powder blend
containing a pharmaceutically active agent [], a binder [], and optionally a
pharmaceutically-acceptable carrier” (Luber 127; see Final Act. 3).
FF 3. Luber provides “[ejxamples of suitable meltable binders[, which]
include: fats such as [] palm kernel oil, cottonseed oil, [] and soybean oil”
(Luber 146; Final Act. 3; cf Spec. 4: 11—12 (“The lipid [component of
Appellants’ claimed invention] can be, for example, an animal or plant
derived fat, wax, or oil”); Spec. 26: 20-21 (“Exemplary plant-derived fats
that can be used include [] palm kernel oil, soybean oil, cottonseed oil, and
mixtures thereof’))
FF 4. Luber discloses that “the powder blend contains at least one
carbohydrate,” wherein “[e]xamples of carbohydrates include, but are not
limited to, water-soluble compressible carbohydrates such as sugars (e.g.,
dextrose, sucrose, maltose, isomalt, and lactose), starches (e.g., com starch),
6 Examiner’s Sept. 12, 2014 Office Action.
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Application 13/370,505
sugar-alcohols (e.g., mannitol, sorbitol, maltitol, erythritol, lactitol, and
xylitol), and starch hydrolysates (e.g., dextrins, and maltodextrins)” (Luber
1 55; Final Act. 3; cf. Spec. 4: 4—6 (“the sugar substitute of the dissolvable
formulation can comprise isomalt and/or the sugar alcohol syrup of the
dissolvable formulation can comprise maltitol syrup”); Spec. 21: 17—20
(“Exemplary sugar alcohol syrups [] include maltitol syrup, xylitol,
mannitol, glycerol, erythritol, threitol, arabitol, ribitol, mannitol, sorbitol,
dulcitol, iditol, isomalt, lactitol, and polyglycitol syrups. Other syrups, such
as com symp, golden symp, or molasses can be used”)).
FF 5. Luber discloses that “[t]he carbohydrate(s) may be present at [a]
level of about 5 percent to about 95 percent of the powder blend/tablet”
(Luber | 56; see Final Act. 3).
FF 6. Luber discloses that “[t]he powder blend/tablet [] includes at least
one pharmaceutically active agent[, such as] nicotine” (Luber | 57; see also
id. 1 68; see Final Act. 3).
FF 7. Examiner finds that Luber “does not teach [a] formulation
comprising sugar alcohol capable of forming a glassy matrix” or
“pharmaceutical compositions comprising sugar alcohol symp in an amount
from 0.1 to 2%” (Final Act. 3^4).
FF 8. Andersson “relates to nicotine-containing pharmaceutical
formulations for intraoral delivery of nicotine to a subject” (Andersson 11;
see also id. 178; Final Act. 4).
FF 9. Andersson’s formulations may comprise sweeteners “to improve the
taste,” wherein the “[sjweeteners comprise one or more synthetic or natural
sugars, i[.]e[.] any form of carbohydrates suitable for use as sweetener, as
well as so called artificial sweeteners such as saccharin, sodium saccharin,
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Application 13/370,505
aspartame . . and “may [also] be selected from the group consisting of
sugar alcohols, such as sorbitol, xylitol[], sorbitol, mannitol, glycerol,
xylitol, erythritol, maltitol syrup [], isomalt, lactitol; and mixtures of sugars
including glucose syrup . . (Andersson 194; Final Act. 4)
FF 10. Examiner finds that Andersson “specifically [discloses] the use of
various sugar syrups and/or sugar alcohol syrups as sweeteners [] and
provides several examples demonstrating that [the] amount of sweeteners
can range from 0 to about 20%” and provides “several examples [] that
include sweeteners in an amount of 0.5 and 0.3%” (Final Act. 4, citing
Andersson H 94 and 140-190).
FF 11. Dam discloses
A lozenge [] that has stable pH and stable levels of active
ingredient[, such as nicotine,] over time[, which] comprises a
combination of (i) at least one gum and (ii) at least one non­
crystallising sugar or non-crystallising sugar alcohol in a matrix
designed for controlled buccal delivery of a drug. The lozenge
also contains water and optimal components selected from
flavorings, taste masking agents, colourings, buffer
components, pH adjusting agents, excipients, stabilizers and
sweeteners.
(Dam, Abstract; 169; Final Act. 4.)
FF 12. Dam discloses “preferred lozenges [] containing water, gum acacia,
non-crystalizing sorbitol, non-crystallising xylitol, non-crystallising maltitol,
non-crystallising isomalt or other non-crystalliizing sugar alcohol
derivatives, homologues or associated sugars” (Dam 196; Final Act. 4).
FF 13. Dam discloses that “[t]he non-crystalline nature of the matrix yields
a glassy, amorphous lozenge which is generally translucent and flexible”
(Dam 151; Final Act. 4—5).
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Application 13/370,505
FF 14. Examiner finds that “Dam provides several examples of
compositions comprising about 5% sugar alcohol syrup” (Final Act. 5, citing
Dam 1107 andH 137—171 (Examples 2—14)).
ANALYSIS
Based on the combination of Luber, Andersson, and Dam, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious
to utilize the nicotine-containing formulations as taught by
Andersson and Dam in multi-layered pharmaceutical
compositions taught by Luber, because both Andersson and
Dam teach that such compositions may include nicotine in any
form, whereas Luber teaches the multi-layered pharmaceutical
composition providing aesthetically pleasing chewable and/or
orally disintegrating nicotine-comprising tablets that can be
produced by conventional means and will be stable during the
storage.
(Final Act. 5.) We are not persuaded.
Examiner relies on Luber to suggest, inter alia, a layered tablet
comprising carbohydrates, such as sugars, sugar-alcohols, starch
hydrolysates and sugar alcohol syrup, in an amount of “about 5 percent to
about 95 percent of the [Jtablef ’ (FF 4—5). Examiner finds, however, that
Luber fails to disclose a formulation, for either of its tablet layers, that
comprises a sugar alcohol that is: (1) “capable of forming a glassy matrix”
or (2) “in an amount from 0.1 to 2%” by weight of the formulation (FF 7).
Examiner, therefore, turns to Andersson and Dam to make up for this
deficiency in Luber.
Andersson discloses that any number of synthetic or natural
sweeteners may be added to formulations “to improve the[ir] taste” (FF 9).
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Application 13/370,505
In this regard, Examiner finds that Andersson discloses formulations that
comprise “sweeteners [in the] range [of] from 0 to about 20%” (FF 10).
Examiner failed to establish an evidentiary basis on this record to
support a conclusion that the combination of Fuber and Andersson make
obvious the specific amount of sugar substitute and sugar alcohol syrup
required by Appellants’ claimed invention. Specifically, at least about 80%
by weight of a sugar substitute and from about 0.1% to about 2% by weight
of a sugar alcohol syrup. To the contrary, the combination of Fuber and
Andersson makes clear that any number of synthetic or natural
carbohydrates may be used in their formulations in a range of between of
“about 5 percent to about 95 percent of the []tablef’, for Fuber (FF 4—5), or
“from 0 to about 20%,” for Andersson (FF 9—10; see also App. Br. 10).
We recognize Examiner’s assertions regarding overlapping ranges and
routine optimization (see Ans. 7—8). While Examiner is correct in that the
“discovery of an optimum value of a result effective variable in a known
process is ordinarily within the skill of the art,” In re Boesch, 617 F.2d 272,
276 (CCPA 1980) (citations omitted), our reviewing court has found an
exception to this general rule where, as here, “the parameter optimized was
not recognized to be a result effective variable,” In re Antonie, 559 F.2d 618,
621 (CCPA 1977). Examiner failed to establish a reason or evidentiary basis
on this record to support a conclusion that Fuber and/or Andersson disclose
a preference for any particular carbohydrate, such as a sugar substitute in
combination with a sugar alcohol syrup. Examiner further failed to establish
an evidentiary basis on this record to support a conclusion that a person of
ordinary skill in this art would have recognized, based on Fuber and/or
Andersson, the need to optimize the amounts of sugar substitute and sugar
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Application 13/370,505
alcohol syrup in such a way that would have necessarily led to Appellants’
claimed composition, which requires at least one component of the multi­
layered composition to be, inter alia, translucent, wherein the sugar alcohol
is capable of forming a glassy matrix (see Ans. 7—8; cf. App. Br. 9 (“[t]here
is nothing in the cited references to teach or suggest the provision of a
product comprising the[] [claimed] components and nothing to teach or
suggest that modifying the references as alleged by the Examiner to obtain
such a product would lead to such a product, exhibiting translucency”)).7
At best, Examiner relies on Dam to disclose that it is “[t]he non­
crystalline nature of the matrix [that] yields a glassy, amorphous lozenge
which is generally translucent and flexible” (FF 13). In this regard, Dam
discloses the use of a number of non-crystallizing sugars and sugar alcohol
derivatives, homologues or associated sugars. However, the about 5% sugar
alcohol syrup concentration of Dam’s formulation is outside the range of
from about 0.1% to about 2% by weight of a sugar alcohol syrup required by
Appellants’ claimed invention (see App. Br. 12—13; Reply Br. 2—3; FF 14).
Therefore, based on the evidence and reasoning presented by
Examiner, even if a person of ordinary skill in this art would have been led
to select a sugar substitute and a sugar alcohol syrup, from the combination
of Fuber, Anderson, and Dam, to formulate one portion of a multi-layered
pharmaceutical composition; Dam suggests that in order to formulate a
translucent, dissolvable composition, wherein the sugar alcohol is capable of
forming a glassy matrix, the sugar alcohol syrup should be present in an
7 Appellants content that “[although the product recited in the pending
claims is not indicated to be translucent, the dissolvable formulation present
as one component thereof is clearly recited to be translucent” (App. Br. 7)
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Application 13/370,505
amount of about 5%, which is more than double the upper bound of the
sugar alcohol syrup range required by Appellants’ claimed invention (see FF
14; see App. Br. 12—13; Reply Br. 2—3).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1—15 and 26
under 35 U.S.C. § 103(a) as unpatentable over the combination of Luber,
Anderson, and Dam is reversed.
REVERSED
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