Ex Parte Rubino

Patent Trials and Appeals Board

Mar 26, 2019

11596090 - (D) (P.T.A.B. Mar. 26, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/596,090 11/09/2006
20999 7590 03/28/2019
HAUG PARTNERS LLP
745 FIFTH A VENUE - 10th FLOOR
NEW YORK, NY 10151
FIRST NAMED INVENTOR
Orapin P. Rubino
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.
247002-202 3448
EXAMINER
SINGH, RANDEEP
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
03/28/2019 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):
docket@haugpartners.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ORAPIN P. RUBIN0 1
Appeal2018-005582
Application 11/596,090
Technology Center 1600
Before DONALD E. ADAMS, ROBERT A. POLLOCK, and
TA WEN CHANG, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the final rejection of
claims 18-30. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellant identifies the real party in interest as Glatt Air Techniques, Inc.
Br. 2.
Appeal2018-005582
Application 11/596,090
STATEMENT OF THE CASE
Appellant's invention relates to the preparation of "pellets hav[ing] an
inner zone comprising a plurality of micropellets ... dispersed in a matrix of
a[ n] inert pharmaceutical excipient, a biologically active agent and
optionally having an outer zone comprising a surface layer comprising a
pharmaceutical excipient with or without a biologically active agent." Spec.
4:4--10; Abstract. "[The] outer layer maybe [sic] formed by applying to the
matrix pellet a powder which comprises a substantially dry, free flowing
inert powder which is a pharmaceutical excipient which forms a non-tacky
surface when placed in contact with water." Id. at 17:11-15.
"The pellets of the invention are typically prepared using an apparatus
which propels particles against a tangentially arranged inner wall in such a
manner that a rolling motion is imparted to the moving pellets." Id. at
12:26-30. In forming the pellet matrix, "liquid and powder stream
components may be combined to form a single feed." Id. at 13:13-14.
[ A ]n outer zone of the pellet may [then] be formed by feeding
dry powder to the tumbling bed of pellets in order to cause the
pellets to grow to their selected final dimension as well as to
dry and smooth the pellets into a highly uniform and highly
spherical product.
Id. at 13:14--19.
Independent claims 18 and 19 are illustrative of the issues on appeal.
Claim 18 recites:
18. A process for making spherical pharmaceutical pellets
having an aspect ratio of less than 1.4 which is determined by
dividing the length of the pellet by the width found at an angle
of 90°, said pellet being adapted for use in the delivery of a
biologically active agent, said method comprising:
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Application 11/596,090
(a) contacting a plurality of micropellets with a
pharmaceutically acceptable liquid or a solution or
dispersion of a binder as said micropellets are subjected
to a rolling movement in a chamber of a device so as to
bind the micropellets together to form said pellet; and
(b) feeding a sufficient amount of a substantially dry,
pharmaceutical excipient in the form of a free flowing
powder which forms a non-tacky surface when placed in
contact with water, into the chamber to provide on said
pellets an outer zone having an external arcuate surface;
wherein no liquid is fed into the chamber during the step of
feeding the free flowing powder into the chamber.
Claim 19, set forth in full in Appellant's Claims Appendix, recites a
process for making spherical pharmaceutical pellets involving an operating
apparatus containing a rotor and rotor chamber and comprising:
(a) feeding micropellets, which include the biologically active
agent, to the chamber of the operating apparatus such that
said micropellets, which are circulated by kinetic energy by
said rotor under the influence of kinetic energy, move from
said rotor to an inside surface of said guide vanes before
falling back onto said rotor;
(b) rotating said rotor, while feeding air and spraying a solution
or a dispersion of a pharmaceutically acceptable liquid with
or without a binder into said rotor chamber for a sufficient
amount of time to form pellets having a desired diameter;
and
( c) feeding, to the chamber, a sufficient amount of a free-
flowing powder comprising a substantially dry,
pharmaceutical excipient to provide on said particles an
outer zone comprising a layer formed from said substantially
dry, pharmaceutical excipient;
wherein no liquid is fed into the chamber during the step of
feeding the free flowing powder to the chamber.
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Appeal2018-005582
Application 11/596,090
Claims 18-30 stand rejected under 35 U.S.C. § I03(a) as unpatentable
over the combination of Kamada, 2 Bretschneider, 3 and Hogan4' 5
FACTUAL FINDINGS
We have reviewed Appellant's contentions that the Examiner erred in
rejecting claims 18-30 as unpatentable over the cited art. We disagree with
Appellant's contentions and adopt the findings concerning the scope and
content of the prior art set forth in the Examiner's Answer. For emphasis,
we highlight and address the following:
FPL Kamada discloses:
[S]pherical granules comprising the spherical seed cores coated
with a powdery layer comprising active ingredients and having
an outer layer of coating provided on the powdery layer; and a
process for the production of spherical granules, comprising the
steps of coating the spherical seed cores with powder
comprising active ingredients using an aqueous binding
solution, spraying an aqueous solution or suspension of a
coating agent thereon, and drying the resulting coated granules.
Kamada, Abstract; see id. at 2:39--47, 4:52-5:7, 7:47-8:17. Kamada
discloses, for example, that "[ w ]hile rotating ... spherical seed cores in a
centrifugal fluidized type corting machine, an aqueous binder solution is
sprayed thereon. Simultaneously a powder containing a
pharmacologically active ingredient and, if necessary, an excipient is fed
2 Kamada, US 5,505,983, issued Apr. 9, 1996.
3 Bretschneider et al., US 6,354,728 Bl, issued Mar. 12, 2002.
4 Hogan et al., US 6,406,738 Bl, issued June 18, 2002.
5 The provisional obviousness-type double patenting rejection of claims 18-
30 over US Application No. 14/211,037 was withdrawn in the Advisory
Action dated May 3, 2017. Final Act. 9; Adv. Act. 2.
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Application 11/596,090
thereto to coat the spherical seed cores with the powder to form
elementary granules." Id. at 4:52-58. "The resulting spherical granules
optionally can be further coated with a powder layer comprising a
pharmacologically active ingredient and a layer of a coating agent." Id.
at 5:58-61.
FF2. Bretschneider discloses a device for producing a pourable
product comprising coated seed grains or cores. Bretschneider,
Abstract, 5: 15-21. The device comprises:
a rotor chamber in which a rotor is arranged with a vertical
rotor axis. The rotor has, at least in its radially outer third, the
shape of a conical shell. Guide vanes for circulating starting
materials or the product are arranged statically on an inner wall
of the rotor chamber above the plane of the upper edge of the
rotor.
Id. at Abstract, claim 1. In one embodiment,
[p ]owdered sugar is introduced into the rotor 4 through the feed
14 in an extremely simple way. Finely atomized water is
sprayed in parallel or subsequently onto the circulating
powdered sugar via the central feed 15. The fine water drops
are surrounded immediately by the powdered sugar and a basic
core is formed. The size of the basic cores can be influenced by
the rotational speed and geometry of the guide vanes and by the
quantity and size of the drops of fed water.
Id. at 8: 1-9 (referencing Fig. 1 ).
FF3. Hogan discloses a method for coating a core for a
pharmaceutical dosage form "which comprises electrostatically
applying to a surface of the core a powder material comprising active
material." Hogan, Abstract. Hogan teaches that where particles of a
selected powder material have "a tendency ... to bounce back from a
surface of the tablet core, a pretreatment composition may be applied
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Application 11/596,090
to a surface of the tablet core." Id. at 5:13-15. "The pretreatment
composition may be a liquid and may increase the forces acting on the
particles to hold them on the core." Id. at 5 :21-23; see also id. at
15:2-18 (describing method steps wherein exposed surface of core is
"sprayed with charged droplets of a capture-enhancing liquid, for
example polyethylene glycol" prior to exposure to electrostatic
powder coating.), 18:55-19:16 (Example 7) (tablet cores pretreated
with polyethylene glycol spray followed by powder coating.); claims
58---60 ( dependent claims reciting pretreatment with liquid
polyethylene glycol.).
ANALYSIS
Obviousness
The Examiner finds that Kamada teaches or suggests most of the
processing steps of independent claim 18 and its depend claims, and further
relies on Bretschneider for teaching the apparatus limitations of, e.g., claim
19. Final Act. 3-8; Ans. Kamada teaches the simultaneously application of
a liquid and a powder onto a seed core, which may be further coated with a
powder layer. See FF 1. With respect to the limitation "wherein no liquid is
fed into the chamber during the step of feeding the free flowing powder to
the chamber," the Examiner finds that "[Hogan] teach[es] the application of
a pretreatment composition to their cores prior to the application of a powder
coating material," where "[t]he pretreatment composition can be a capture-
enhancing fluid," and "[t]he powder coating material is then applied
separately and subsequently to the cores as a dry powder." Final Act. 6.
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Application 11/596,090
In light of Hogan, the Examiner finds that
it would have been well within the ordinary level of skill in the
art ... to apply a pretreatment composition such as a capture-
enhancing fluid to a core prior to applying a dry free-flowing
powder coating material to the core, such that no liquid is fed
during the application of the free-flowing powder coating
material.
Final Act 6-7. With respect to motivation to pretreat the cores of Kamada
prior to application of a powder coating as taught by Hogan, the Examiner
finds that one of ordinary skill in the art
would have been motivated to alter and optimize the apparatus
of Kamada such that cores are pretreated with an aqueous
binder solution immediately prior to, and not simultaneously
with, being contacted by a dry powder coating material, in order
to reduce the likelihood of a powder particle arriving at core
from bouncing off the core.
Ans. 7.
Appellant argues that the configuration of Hogan's electrostatic
method and apparatus requires that "liquid is fed into the chamber of Hogan
during the step of contacting the tablet cores with the powder, contrary to the
recitations in claims 18, 19, and 20"; that Hogan fails to "teach, or relate to,
feeding any dry powder into a chamber that already contains pellets as set
forth in claims 18, 19, and 20"; that the electrostatic spray gun and fusing
station taught by Hogan is incompatible with the "centrifugal fluidized type
of machined . . . needed to form elementary granules from spherical seed
cores as taught by Kamada"; and that "the pretreatment in Hogan is
particular to [Hogan's] specific electrostatic coating method." App. Br. 19-
23.
We do not find Appellant's argument persuasive. In determining
obviousness, "it is not necessary that the inventions of the references be
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Application 11/596,090
physically combinable to render obvious the invention under review." In re
Sneed, 710 F.2d 1544, 1550 (Fed. Cir. 1983). Rather, "the test is what the
combined teachings of the references would have suggested to those of
ordinary skill in the art." In re Keller, 642 F.2d 413,425 (CCPA 1981).
Accordingly, "one cannot show non-obviousness by attacking references
individually where, as here, the rejections are based on combinations of
references." Id. at 426. With that guidance in mind, we agree with the
Examiner that "Hogan was cited primarily for teaching the application of a
pretreatment composition, such as a capture-enhancing fluid, to cores prior
to the application of a powder coating material for the purpose of producing
coated cores," and thus, irrespective of the precise apparatus used, "because
Hogan teaches that a pretreatment composition enhances the capture of a
powder coating material on their cores, a skilled artisan would have been
motivated to alter and optimize the apparatus of Kamada, without altering
the operability and purpose of the [Kamada's] apparatus." Ans. 4--5.
In sum, Kamada teaches the simultaneously application of a liquid
and a powder onto a seed core and drying the resulting coated granules, 6
whereas Hogan teaches the sequential application of a liquid and a powder
to a core where the liquid acts as a pretreatment to facilitate binding of the
6 Supportive but not necessary to the rejection, Kamada's teaching that these
coated seed cores "can be further coated with a powder layer" indicates that
Kamada contemplates the application of powder in the absence of a liquid,
i.e., under conditions wherein no liquid is fed into the chamber during the
step of feeding the free flowing powder to the chamber. See FF 1; see also
FF2 (Bretschneider disclosing that "[f]inely atomized water is sprayed in
parallel or subsequently onto the circulating powdered sugar") ( emphasis
added).
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Application 11/596,090
powder. See FFI, 3. Given that a core may be sequentially treated first with
liquid and then with a powder as taught by Hogan, a person of ordinary skill
in the art would have found it prima facie obvious to optimize the method of
Kamada by pretreating a core with a liquid to enhance the capture of a
powder coating material, followed by the application of a free flowing
powder such no liquid is fed into the chamber during the step of feeding free
flowing powder into the chamber.
With respect to claims 22 and 23, Appellant further argues that one of
ordinary skill in the art would not have been motivated to combine Hogan
with Kamada because Hogan incorporates pharmaceutically active material
into the seed cores whereas Kamada teaches the coating of
pharmacologically inactive seed cores. App. Br. 24--25. We do not find
Appellant's arguments persuasive because both references are directed to
processes for powder coating cores for pharmaceutic use and are, thus,
relevant to whether "a powder particle arriving at core [bounces] off the
core." See Ans. 7. Appellant does not explain adequately, nor do we
discern, why one of ordinary skill in the art would decline to combine the
teachings of Hogan and Kamada based on whether the powder, the core to
be coated, or both, contain an active ingredient. Moreover, contrary to
Appellant's argument, Kamada expressly teaches that previously coated
"spherical granules can be further coated with a powder layer comprising a
pharmacologically active ingredient," thus indicating that Kamada, like
Hogan, contemplates the application of powder coating to a
pharmaceutically active seed core. Id. at 8 ( citing Kamada 5:58---60).
In view of the above, we conclude that the Examiner has established a
prima facie case ofunpatentability, which Appellant has not rebutted.
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Application 11/596,090
SUMMARY
We affirm the rejection of claims 18-30 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Kamada, Bretschneider, and Hogan.
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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