Ex Parte Hübinette et al

Patent Trial and Appeal Board

Aug 15, 2017

13255980 (P.T.A.B. Aug. 15, 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.
13/255,980 12/05/2011 Fredrik Htibinette 4010293-188153 2778
23570 7590 08/17/2017
PORTER WRIGHT MORRIS & ARTHUR, LLP
INTELLECTUAL PROPERTY GROUP
41 SOUTH HIGH STREET
29TH FLOOR
COLUMBUS, OH 43215
EXAMINER
PROSSER, ALISSAJ
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
08/17/2017 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):
ipdocket @ porterwright .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FREDRIK HUBINETTE,
THOMAS KULL, and LARS BJORKHOLM
Appeal 2016-003498
Application 13/255,9801
Technology Center 1600
Before RICHARD M. LEBOVITZ, FRANCISCO C. PRATS, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a product for
delivering a biologically active substance to the oral cavity of a subject. The
Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
STATEMENT OF THE CASE
The following rejections are before us for review:
1 Appellants state that the “real party in interest for the present application is
the Assignee, Excellent Tech Products I Sverige AB of Vegby, Sweden.”
App. Br. 1.
Appeal 2016-003498
Application 13/255,980
(1) Claims 24, 25, 28-33, 36-40, and 49, under 35 U.S.C. § 103(a),
for obviousness over Ek,2 Kinam,3 and Stenberg4 (Ans. 2—8); and
(2) Claims 26 and 27, under 35 U.S.C. § 103(a), for obviousness over
Ek, Kinam, Stenberg, and Jonsson5 (Ans. 8—10).
Claim 24, the only independent claim on appeal, reads as follows
(App. Br. 18):
24. An oral delivery product comprising:
a semi-permeable pouch designed for placement in an
oral cavity of a subject; and
multiple solid particles of at least one alginate salt of
monovalent cation, wherein said multiple solid particles (i)
comprise at least one biologically active substance within a
matrix formed by said at least one alginate salt of monovalent
cation, (ii) have an average diameter in a range of from 100 pm
to 5 mm, (iii) are dissolvable in the moist environment of the oral
cavity, and (iv) are enclosed in said semi-permeable pouch.
OBVIOUSNESS—
EK, KINAM, AND STENBERG
The Examiner’s Position
In rejecting claims 24, 25, 28—33, 36-40, and 49 over Ek, Kinam, and
Stenberg, the Examiner cited Ek as disclosing an oral delivery product
composed of a pouch that contained cellulose particles, with nicotine
2 US 2005/0053665 A1 (published Mar. 10, 2005).
3 ‘“Solid dosage forms: powders and granules,’ Chapter 2, available online
as of January 16, 2011.” Ans. 2—3 (emphasis omitted); see also
http://kinam.eom/Leetures/363/2.%20Powders%20&%20Granules%20Text.
pdf (PTO-892 (List of References cited by Examiner)) (entered Aug. 14,
2014).
4 WO 2007/073346 A1 (published June 28, 2007).
5 US 2006/0147498 A1 (published July 6, 2006).
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Application 13/255,980
adsorbed thereto, in the form of a powder. Ans. 3. The Examiner cited
Kinam as evidence that pharmaceutical powders were known to have
standard particle sizes within Appellants’ claimed range. Id.
The Examiner found that Ek’s oral delivery product differed from the
Appellants’ claimed product in that “Ek do[es] not teach particles
comprising at least one alginate salt of a monovalent cation that is
dissolvable as required by claim 24.” Id. at 4. To address that deficiency,
the Examiner cited Stenberg as disclosing the use of a dissolvable alginate
film to deliver nicotine to the oral cavity. Id. at 5—6.
Based on the references’ combined teachings, the Examiner reasoned
that an ordinary artisan would have considered it obvious to modify Ek’s
pouch by including therein
a matrix powder of nicotine and a well-defined alginate salt of a
monovalent cation inclusive of Protanal® LFR 5/60 and
Protanal® LF 10/60 as taught by Stenberg in Examples 6 and 7
which further comprise glycerol and sorbitol plasticizers and
phosphate buffer to pH 8.5 in order to obtain reproducible
nicotine release profiles and advantageous concentration v. time
profiles of the nicotine active within the body of the subject.
Id. at 7.
As to the particle size required by Appellants’ independent claim 24,
the Examiner reasoned further that, light of the references’ teachings, it
would have been obvious to optimize the particle sizes of Stenberg’s
alginate “in order to gain a further degree of control over the dissolution rate
of the nicotine-alginate salt of a monovalent cation powder particles.” Id. at
8.
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Application 13/255,980
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.
In KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), although
the Supreme Court emphasized “an expansive and flexible approach” to the
obviousness question, the Court also reaffirmed the importance of
determining “whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.'1'’ Id. at 418 (emphasis
added).
Thus, as our reviewing court has explained, an examiner must “still
be careful not to allow hindsight reconstruction of references to reach the
claimed invention without any explanation as to how or why the references
would be combined to produce the claimed invention.” Innogenetics, N. V. v.
Abbott Labs., 512 F.3d 1363, 1374 n.3 (Fed. Cir. 2008) (emphasis added).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations and citations omitted).
In the present case, having carefully considered the positions of both
the Examiner and Appellants, Appellants persuade us that a preponderance
of the evidence does not support the Examiner’s finding that the cited
references would have suggested the specific combination of elements
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recited in claim 24 to an ordinary artisan. In particular, Appellants persuade
us that the cited combination of references would not have suggested
including dissolvable alginate particles as the nicotine delivery vehicle in
Ek’s pouches, as the Examiner posits.
In contrast to the “dissolvable” alginate particles contained within a
pouch required by Appellants’ claim 24, Ek discloses oral drug delivery
devices composed of pouches that contain highly porous insoluble cellulose,
to which nicotine is adsorbed, the nicotine being released from the cellulose
when the pouch is placed in the subject’s oral cavity. See Ek 138 (“The
cellulose is readily wetted with water and saliva, but is not soluble in said
liquids, and it can therefore be regarded as an inert carrier”); see also id. 1
116—18 (describing “buccal sachet” as a water/saliva-permeable teabag that
contains the adsorbed nicotine-cellulose matrix allowing release of the
nicotine from 0-40 minutes after placement in the mouth under the lip).
Ek teaches that the particular type of cellulose disclosed for use in its
pouches, “non-seed organism cellulose,” has a “unique structure and . . .
exceptionally large surface area” so as to “protect nicotine in a suitable
way.” Id. 141. As Appellants contend, Ek teaches that the type of cellulose
used in its delivery devices is particularly advantageous in the described
applications:
By absorption into cellulose of non-seed organism origin
an amount of nicotine being large in relation to the amount of
cellulose can be transferred into solid and chemically stabile
form. This stabile solid form is advantageous in connection with
production of many dosage forms, such as chewing gums and
tablets. The release of nicotine from cellulose of non-seed
organism origin may be immediate.
Id. 145.
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In contrast to Ek’s particulate delivery system enclosed within a
pouch, Stenberg describes nicotine-containing film compositions composed
of alginate, the films being formed by mixing the nicotine, alginate, and
other ingredients into a homogeneous solution, and then drying the solution
in the form of a film. Stenberg 21:14—22:11 (Examples 6 and 7). Stenberg
discloses that, when placed in the mouth against the palate, a 3 cm2 dosage
unit prepared according to its Example 6 dissolved within 1.5 minutes, and a
3 cm2 dosage unit prepared according to its Example 7 dissolved within 45
seconds when placed in the mouth. Id. at 22:4—11.
As Appellants contend, Stenberg explains that its films preferably
deliver the drugs contained within them by adhering to the moist surface in
the subject:
The present invention is based on the surprising finding that by
use of an alginate composition as defined herein, as a stand-alone
film forming agent, a film that is adhesive to a moist surface of
the body of a mammal and has a rapid dissolution profile in
contact with the moist surface can be obtained. Very
advantageously, the film of the invention is bioadhesive, which
means that when applied to a moist surface, such as a mucosa or
a cornea, it adheres thereto, preferably within seconds.
Id. at 5:31—6:2. Given Stenberg’s disclosure of the importance of direct
adhesion of its films to moist surfaces, including in the oral cavity, we agree
with Appellants that, even when viewed alongside Ek, Stenberg would not
have suggested including its films inside Ek’s pouches, which would
interfere with Stenberg’s desired direct contact between the film and a moist
oral cavity surface.
In addition to its teaching, noted above, of the particular advantages of
its drug-containing films, Stenberg consistently discloses its inventive
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Application 13/255,980
delivery device as being in the form of a film. See Stenberg generally. The
Examiner, therefore, does not persuade us (see Ans. 7, 12, 14, 16) that rather
than suggesting the use of a film, Stenberg instead would have suggested
using alginate in the form of a powder as a delivery vehicle for nicotine.
Moreover, given Ek’s disclosure, noted above, as to the particular suitability
of its disclosed type of insoluble cellulose carrier in its pouches, we are not
persuaded that the Examiner has explained adequately why an ordinary
artisan instead would have been prompted to use a delivery device composed
of nicotine and dissolvable nicotine-containing alginate particles in Ek’s
pouches, especially given Stenberg’s teachings regarding the advantages of
its delivery device in film form.
We acknowledge, as the Examiner contends, that Stenberg discloses
that its films can take a variety of shapes and sizes:
The dosage unit may be of any suitable surface area, having
regard to the concentration of the active ingredient within the
film and the suitable dosage to be administered. As an example,
a dosage unit having a surface area of from 1 cm2 to 10 cm2 may
be selected when the film is to be applied within the oral cavity,
while a smaller surface area, such as from 0.04 cm2 to 1 cm2 may
be preferable when the film is to be applied in the eye. It will be
within the knowledge of the skilled person to adapt the size and
shape of the film dosage unit having regard to such parameters
as the loading of the active ingredient(s) within the film, the
required dosage, the site of administration to the body of the
mammal subject etc. Also, it should be realized that the film
dosage unit may have any appropriate shape to match the site of
administration of the active ingredient, e.g. it may be rectangular,
circular, oblong, oval etc.
Stenberg 10:19-28. Even if the particle size were prima facie obvious based
on Stenberg, Stenberg still teaches that such sizes must be films, and the
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Examiner still has not provided a reason to place the films of any size in a
pouch as required by the clams.
In sum, for the reasons discussed, we are not persuaded that Examiner
has explained adequately why the cited references, when viewed in
combination, would have suggested including, in a semi-permeable pouch
designed for placement in an oral cavity of a subject, multiple dissolvable
solid particles of at least one alginate salt of a monovalent cation, the
particles containing at least one biologically active substance within a matrix
formed by the alginate salt, and having an average diameter in a range of
from 100 pm to 5 mm, as Appellants’ claim 24 requires. We, therefore,
reverse the Examiner obviousness rejection of claim 24, and its dependent
claims.
OBVIOUSNESS—
EK, KINAM, STENBERG, AND JONSSON
In rejecting claims 26 and 27 over Ek, Kinam, Stenberg, and Jonsson,
the Examiner relied on the teachings in Ek, Kinam, and Stenberg, discussed
above, and cited Jonsson as evidence that it would have been obvious to
further include in Ek’s pouches the microcrystalline cellulose particles
recited in claims 26 and 27, both of which depend ultimately from claim 24,
discussed above. Ans. 8—10.
Because the Examiner does not explain why Jonsson remedies the
deficiencies of Ek, Kinam, and Stenberg, discussed above as to claim 24, we
reverse this rejection as well.
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SUMMARY
For the reasons discussed, we reverse both of the Examiner’s
rejections.
REVERSED
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