Ex Parte Piskorz

Patent Trial and Appeal Board

Dec 27, 2016

13270682 (P.T.A.B. Dec. 27, 2016)

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.
13/270,682 10/11/2011 Hanna Piskorz 7158-P34827US04 6936
1059 7590 12/27/2016
BERESKIN & PARR LLP/S.E.N.C.R.L., s.r.l.
40 KING STREET WEST
40th Floor
TORONTO, ON M5H 3Y2
CANADA
EXAMINER
CRUZ, KATHRIEN ANN
ART UNIT PAPER NUMBER
1621
MAIL DATE DELIVERY MODE
12/27/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HANNA PISKORZ1
Appeal 2014-009832
Application 13/270,682
Technology Center 1600
Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
TAWEN CHANG, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method of
preparing a nicotine formulation suitable for inhalation. The Examiner
rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses a process in which “a composite
medicament comprising nicotine and a pharmaceutical grade sugar is
produced in a form suitable for inhalation by a user.” Spec. 121. In the
1 Appellant identifies Nico Puff Corporation as the real party in interest.
App. Br. 3.
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Application 13/270,682
process, “a non-spheronized pharmaceutical grade sugar and nicotine are
mixed with a liquid carrier so as to form a flowable mixture which may then
be . . . rapidly dried such as in a spray drier.” Spec. 122.
The Specification discloses:
In accordance with the present disclosure, the Applicants
have unexpectedly found that the form or shape of the
pharmaceutical grade sugar that is combined with the nicotine
before spray drying aids in the preparation of a composite
material which is not deposited in the upper airways of a user
upon inhalation. In particular, if spheronized sugar is utilized
in the process, then the resultant spray dried product tends to
form as string shaped particles and not spherical particles.
Unexpectedly, non-spheronized sugar, when solubilized and
mixed with the nicotine, will form spherical particles when
spray dried. As the non-spheronized pharmaceutical grade
sugar is further processed by solubilizing the sugar and
combining it with the nicotine formulation in liquid carrier,
followed by spray drying, it is unexpected that the initial form
or shape of the sugar would influence the final powdered
medicament.
Id. 123.
Claim 1 is representative, and reads as follows (App. Br. 14):
1. A method of preparing a nicotine formulation suitable for
inhalation comprising:
(a) combining nicotine, a non-spheronized
pharmaceutical grade sugar and a liquid carrier to
produce a flowable mixture; and,
(b) spray drying the flowable mixture to form spray
dried spherical particles.
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The sole rejection before us for review is the Examiner’s rejection of
claims 1—9 and 11—13 under 35 U.S.C. § 103(a) for obviousness over
Jacobs2 and Foster.3 Ans. 2—7.
OBVIOUSNESS
The Examiner’s Position
The Examiner cited Jacobs as disclosing “a process of including a
smokeless solid particulate fraction into an inhalable nicotine formulation
for the purpose of providing a self propelled aerosol of sufficiently small
particle size to carry the nicotine to the respiratory tree and blood stream.”
Ans. 3. The Examiner noted that Jacobs’s “solid particulates can include
talc, dextrose or other carbohydrates.” Id.
The Examiner found that Jacobs’s process differed from the claimed
process in that Jacobs “does not explicitly teach spray drying of nicotine and
a pharmaceutical grade sugar selected from lactose, dextrose, glucose,
maltose or combinations, or that the particle are spherical and/or dimpled, or
any particular ratio of nicotine to sugar.” Id.
To address those deficiencies, the Examiner cited Foster as disclosing
“pharmaceutical compositions for pulmonary administration with enhanced
stable dispersibility over time and methods of administration of such
compositions.” Id. The Examiner noted in particular Jacobs’s “preferred
method for preparing a dispersible powdered composition comprise[s] spray
drying a homogenous aqueous mixture comprising water, a glass forming
excipient, and an active agent suitable for treating a disease state by
inhalation under conditions sufficient to provide a dispersible powdered
2U.S. Patent No. 4,635,651 (issued Jan. 13, 1987).
3 U.S. Patent No. 6,258,341 B1 (issued Jul. 10, 2001).
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Application 13/270,682
pharmaceutical composition.” Ans. 4. The Examiner also noted Foster’s
Examples 15 and 16, which describe spray dried formulations including
albuterol as the active agent and lactose as the glass forming carbohydrate
excipient. Id. at 4—5.
Based on the references’ teachings, the Examiner concluded that an
ordinary artisan would have considered it obvious to use Foster’s
“carbohydrate glass forming particles with Jacobs[’s] nicotine formulation in
order to make a spray dried carbohydrate/nicotine formulation for use as an
aid to stop smoking.” Id. at 5. The Examiner reasoned that the artisan
would have been motivated to use Foster’s “carbohydrates with the nicotine
to take advantage of the improved dispersibility of the Foster et al.
carbohydrate/active agent spray dried compositions.” Id. The Examiner
reasoned, moreover that, “[a]s both Jacobs and Foster et al. are directed to
methods of active agent delivery via inhalation and as both contemplate the
use of carbohydrates in their preparation one would expect a reasonable
chance for success.” Id.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
We select claim 1 as representative of the rejected claims. 37 C.F.R.
§ 41.37(c)(l)(iv). Appellants’ arguments do not persuade us that a
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Application 13/270,682
preponderance of the evidence fails to support the Examiner’s prima facie
case of obviousness as to claim 1.
Claim 1 recites a method of preparing a nicotine formulation suitable
for inhalation. App. Br. 14. Claim 1 requires, in its first step, combining
nicotine, a non-spheronized pharmaceutical grade sugar and a liquid carrier
to produce a flowable mixture. Id. In its second step, claim 1 requires spray
drying the flowable mixture to form spray dried spherical particles. Id.
As the Examiner found, Jacobs discloses nicotine-containing particles
suitable for inhalation. Jacobs 2:60-3:3. As the Examiner found, Jacobs
discloses that additives suitable for formulation in its inhalable particles
include carbohydrates, such as dextrose. Id. 4:4—11. As the Examiner found,
Jacobs does not disclose that its particles are formed by combining nicotine,
non-spheronized pharmaceutical grade sugar and a liquid carrier to produce
a flowable mixture, and then spray drying the mixture, as recited in claim 1.
As the Examiner found, however, Foster discloses a process of spray
drying “a homogenous aqueous mixture comprising water (with or without
an organic solvent), a glass forming excipient, and an active agent suitable
for treating a disease state by inhalation under conditions sufficient to
provide a dispersible powered pharmaceutical composition . . . Foster
17:1—5. As the Examiner found, Foster discloses that suitable glass forming
excipients include pharmaceutical grade carbohydrates, such as lactose. Id.
12:25—52; see also id. at 39:36-42:49 (Examples 15 and 16 using lactose in
an albuterol-containing formulation).
Foster discloses that preparing formulations according to its methods
result in an inhalable particulate composition with an improved dispersibility
shelf life. See id. 7:17—21 (disclosing that “the dispersibility of the
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Application 13/270,682
powdered composition of this invention when packaged as a unit dosage
form (e.g. as a “blister pack”) does not appreciably change under normal
storage condition over the shelf life of the composition”).
Given Foster’s teaching of the advantageousness of inhalable drug-
containing particulate compositions prepared according to its methods, we
agree with the Examiner that an ordinary artisan had a good reason for, and a
reasonable expectation of success in, using Foster’s methods to prepare the
nicotine-containing particulate compositions taught in Jacobs. We,
therefore, also agree with the Examiner that the combination of Jacobs and
Foster would have suggested the process recited in Appellant’s claim 1.
Appellant’s arguments do not persuade us to the contrary. Appellant
initially argues that neither Jacobs nor Foster teaches using non-spheronized
sugar as an input material in a spray drying process. App. Br. 8—9; see also
Reply Br. 9—12. The Examiner responds that, given Foster’s silence as to
the form of the sugar used in its processes, “it would hold that the sugar used
in the art would be non-spheronized.” Ans. 8.
Because Foster does not limit the shape or form of the sugar used in
its processes to either spheronized or non-spheronized sugar, we find that
Foster would have suggested to an ordinary artisan that either spheronized or
non-spheronized sugar would be useful as the input sugar in its spray drying
processes. We are not persuaded, therefore, that Foster fails to suggest using
non-spheronized sugar, as recited in Appellant’s claim 1, as the input sugar
in its processes.
Moreover, Appellant’s Specification suggests that producing
spheronized sugar-containing materials requires undertaking specialized
actions, such as spray drying, rather than simply using a previously purified
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material. See, e.g. Spec. Tflf 47—53 (exemplifying preparation of spherical
particles by spray drying). In contrast, like Appellant, Foster discloses that
ordinary pharmaceutical grade sugars are useful as its input sugars.
Compare Spec. 134 (USP lactose useful as non-spheronized sugar) and
Spec. 148 (exemplifying ordinary lactose) to Foster 39:36-42:49 (Examples
15 and 16 using U.S.P. grade lactose). Foster, thus, provides no indication
that its input sugars were previously processed in a specialized manner that
would result the spheronized form excluded by Appellant’s claim 1.
Accordingly, for the reasons discussed, Appellant does not persuade
us that the Examiner erred in concluding that it would have been obvious to
use non-spheronized sugar as the input sugar in Foster’s process.
Appellant’s arguments (App. Br. 9-11; Reply Br. 13—14) do not
persuade us that Foster teaches away from producing the spherical particles
required by claim 1. The full text of the passage Appellant relies upon in its
teaching away argument reads as follows:
The spray drying method generally consists of bringing
together a highly dispersed liquid, which is the aqueous
composition defined above, and a sufficient volume of hot air to
produce evaporation and drying of the liquid droplets. The feed
liquid may be a solution, colloidal suspension or emulsion
provided the feed is capable of being atomized. Preferably a
solution is employed. In general the feed is sprayed into a
current of warm filtered air that evaporates the water and
conveys the dried product to a collector. The spent air is then
exhausted with the moisture. While, in general, the resulting
spray-dried powdered particles are homogenous,
approximately spheroidal in shape and nearly uniform in size,
the improvement of this invention result[s] in particles that are
comprised of a glassy matrix and are irregular in shape.
Foster 17:7—22 (emphasis added).
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We agree with Appellant that, in the above passage, Foster describes
the production of irregular shaped particles as the improvement of its
invention. Nonetheless, as is evident, Foster concedes that its spray drying
process, in general, produces spheroidal particles encompassed by claim 1.
Moreover, even interpreting the quoted passage as stating a preference
for irregular-shaped particles over the spheroidal ones generally produced by
spray drying, the teaching of a preference does not teach away from the
unpreferred embodiments. See DePuy Spine, Inc. v. Medtronic Sofamor
Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009) (A reference “does not
teach away ... if it merely expresses a general preference for an alternative
invention but does not ‘criticize, discredit, or otherwise discourage’
investigation into the invention claimed.”) (Citation omitted). In the present
case, Appellant does not identity any teaching in either cited reference
criticizing, discrediting, or otherwise discouraging the production of
spherical particles as recited in Appellant’s claim 1 for use in inhalable
powder compositions.
To that end, Appellant’s arguments (Reply Br. 9—12) do not persuade
us that claim 1 ’s requirement of forming “spherical particles” (App. Br. 14)
fails to encompass the spheroidal particles formed by Foster’s process. We
acknowledge, as noted above, that Foster describes irregular shaped
particles. Foster 7:20-22; see also id. at 22:32—34 (working example
describing “particles hav[ing] a convoluted ‘raisin’ structure scanning
electron microscopy (SEM) analysis . . . rather than a smooth spherical
surface”); id. at 24:61—63 (same); id. at 27:1—3 (same).
Foster also discloses, however, that “the composition of this invention
is a powder with the largest particle size less than about 10 microns (um) in
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diameter with a shape that may be spheroidal or ‘raisin-like’ with surface
convolutions.” Foster 7:34—37 (emphasis added).
It is well settled that, during examination the PTO must interpret
terms in a claim using “the broadest reasonable meaning of the words in
their ordinary usage as they would be understood by one of ordinary skill in
the art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant’s specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
In the instant case, Appellant does not persuade us that claim 1 ’s
recitation of forming spherical particles requires a smooth spherical surface,
or excludes the spheroidal particles described by Foster. In particular,
Appellant’s Specification indicates that, despite having surface irregularities
or convolutions in the form of dimples, the particles nonetheless may be
considered spherical within the spirit of the invention. Spec. 119 (“The
method may also be used to produce particles, which, not only are spherical,
but have an uneven or ‘dimpled’ surface.”); see also App. Br. 16
(Appellant’s claim 13 reciting “spherical particles that have a dimpled
surface”).
Thus, when given its broadest reasonable interpretation consistent
with the Specification, we are not persuaded that claim 1 requires
preparation of smooth-surfaced perfect spheres, but instead encompasses the
particles “with a shape that may be spheroidal or ‘raisin-like’ with surface
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convolutions” described by Foster (7:34—37).4 Accordingly, Appellant does
not persuade us that the Examiner erred in concluding that the cited
references suggest preparing nicotine-containing particles having a spherical
shape encompassed by claim 1.
Appellant also does not persuade us (Reply Br. 14—18) that the
Examiner engaged in improper hindsight in concluding that the process
recited in claim 1 would have been obvious to an ordinary artisan. As noted
above, the Examiner reasoned that an ordinary artisan “would be motivated
to use Foster[’]s . . . carbohydrates with the nicotine [of Jacobs] to take
advantage of the improved dispersibility of the Foster et al.
carbohydrate/active agent spray dried compositions.” Ans. 5. Thus, in
determining whether the process recited in Appellant’s claim 1 would have
been obvious, the Examiner relied on teachings in the prior art—the
dispersibility advantages coming from Foster’s process—rather than
improperly looking to Appellant’s Specification.
In sum, for the reasons discussed, Appellant’s arguments do not
persuade us that the Examiner erred in concluding that the process recited in
representative claim 1 would have been prima facie obvious in view of
Jacobs and Foster. Appellant, moreover, does not identity specific
secondary evidence of nonobviousness sufficient to outweigh the
Examiner’s evidence of prima facie obviousness. Accordingly, because a
preponderance of the evidence supports the Examiner’s conclusion that
representative claim 1 would have been obvious in view of Jacobs and
4 A “spheroid” may be defined as “an object of approximately spherical
shape.” https://www.merriam-webster.com/dictionary/spheroidal, accessed
December 7, 2016.
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Foster, we affirm the Examiner’s rejection of that claim over those
references. The remaining claims fall with claim 1 because they were not
argued separately. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
For the reasons discussed, we affirm the Examiner’s rejection of
claims 1—9 and 11—13 under 35 U.S.C. § 103(a) for obviousness over Jacobs
and Foster.
TIME PERIOD
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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