ADD Advanced Drug Delivery Technologies Ltd.

Patent Trials and Appeals Board

Mar 30, 2021

2020001723 (P.T.A.B. Mar. 30, 2021)

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.
14/209,056 03/13/2014 Antje Weigt 135443-2000.1 7000
20999 7590 03/30/2021
HAUG PARTNERS LLP
745 FIFTH AVENUE - 10th FLOOR
NEW YORK, NY 10151
EXAMINER
HIRT, ERIN E
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
03/30/2021 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 ANTJE WEIGT, WOLFGANG KEMPE,
and BURKHARD SCHLÜTERMANN

Appeal 2020-001723
Application 14/209,056
Technology Center 1600
BEFORE FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–16, 18–23, and 33–41. We have
jurisdiction under 35 U.S.C. § 6(b).

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real parties in interest as the assignees,
IPC Process-Center GmbH & Co. Kg., Grunaer Weg 26, Dresden, Germany
01277, and ADD Technologies Ltd., Kagenstrasse 17, Reinach, Switzerland
4153. Appeal Br. 1.
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We AFFIRM IN PART. Because our affirmance relies on a rationale
somewhat different from the Examiner’s, however, we designate our
affirmance a new ground of rejection under 37 C.F.R. § 41.50(b).
CLAIMED SUBJECT MATTER
The claims are directed to processes for producing carrier pellets for a
pharmaceutically active substance. Claim 1, the sole independent claim on
appeal, is illustrative and reads as follows:
Claim 1: A method for the production of carrier pellets for a
pharmaceutically active substance, the method comprising:
a) producing a liquid formulation by dissolving,
dispersing, or a combination of dissolving and
dispersing at least one pH regulator in at least one
solvent, wherein the liquid formulation contains:
30 to 80% by weight of the at least one pH
regulator; and
15 to 69.5% by weight of the at least one
solvent;
b) introducing the liquid formulation into a fluidized-bed
or spouted-bed unit using at least one nozzle;
c) forming essentially spherical carrier pellets by spray
granulation in the unit wherein the solvent is
evaporated by a drying gas flow; and
d) discharging the carrier pellets from the unit.
Appeal Br. 27.
REFERENCE(S)
The prior art relied upon by the Examiner is:
Name Reference Date
Pawan Seth (“Seth”) US 2002/0192290 A1 Dec. 19, 2002
Stefan Sharpe et al.
(“Sharpe”)
WO 02/080678 A1 Oct. 17, 2002
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Wolfram Eisenreich et al.
(“Eisenreich”)
US 2008/0038347 A1 Feb. 14, 2008
Anne Billotte et al.
(“Billotte”)
US 2003/0158206 A1 Aug. 21, 2003
Daniel R. Twardzik et al.
(“Twardzik”)
US 2002/0123465 A1 Sept. 5, 2002
Walter Rupp (“Rupp”) US 5,463,100 Oct. 31, 1995
Michael Jacob et al.
(“Jacob”)
US 2004/0228978 A1 Nov. 18, 2004
Jens Uhlemann &
Birgit Schleifenbaum
(“Uhlemann”)
US 2001/0021404 A1 Sept. 13, 2001
Eva Lynenskjold &
Lone Norgaard Jorgensen
(“Jorgensen”)2
US 2003/0211168 A1 Nov. 13, 2003
REJECTION(S)
The following rejections are before us for review:
(1) Claims 1–8, 12–16, 18–20, 35, and 37–40, under 35 U.S.C.
§ 103(a) as being unpatentable over Seth, Eisenreich, and Sharpe (Non-Final
Act. 3–10;3
(2) Claims 9–11, under 35 U.S.C. § 103(a) as being unpatentable over
Seth, Eisenreich, Sharpe, Billotte, and Twardzik (Non-Final Act. 10–12);
(3) Claims 21–23, under 35 U.S.C. § 103(a) as being unpatentable
over Seth, Eisenreich, Sharpe, Rupp, and Jacob (Non-Final Act. 12–15);
(4) Claims 33 and 34, under 35 U.S.C. § 103(a) as being unpatentable
over Seth, Eisenreich, Sharpe, and Uhlemann (Non-Final Act. 15–16); and

2 In citing to US 2003/0211168 A1 the Examiner refers to the document as
“Jorgensen.” Non Final Act. 16. We do the same, for consistency and
convenience, although we acknowledge that Jorgensen is not the first
inventor listed, as Appellant points out. See Appeal Br. 9.
3 Non-Final Office Action entered June 13, 2018.
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(5) Claims 36 and 41, under 35 U.S.C. § 103(a) as being unpatentable
over Seth, Eisenreich, Sharpe, and Jorgensen (Non-Final Act. 16–18).
OBVIOUSNESS—
SETH, EISENREICH, AND SHARPE
The Examiner’s Prima Facie Case
The Examiner cited Seth as disclosing a process of preparing carrier
pellets for drugs similar to the process recited in Appellant’s claim 1,
including claim 1’s steps of preparing a liquid formulation containing a
solvent and a pH regulator, such as fumaric or citric acid, introducing the
liquid formulation into a fluidized-bed, forming essentially spherical carrier
pellets by spray granulation, and discharging the carrier pellets from the
fluidized bed unit. Non-Final Act. 4–5.
The Examiner found that Seth’s process differs from the process of
Appellant’s claim 1 in that “Seth does not specifically teach wherein the at
least one pH regulator is present in amounts of 30 to 80% or 15-69.5% of
solvent.” Non-Final Act. 5.
The Examiner cited Eisenreich as evidence that “it was known in the
art to use high amounts of pH regulators when necessary for pharmaceuticals
and that the choice of the pH modifier strongly depends on the active
substances to be used and is selected to control the solubility/bioavailability
of the active substance.” Non-Final Act. 6.
In particular, the Examiner cited Eisenreich as teaching
“pharmaceutical pellets/granules/cores [that] can comprise 30-100% of a pH
regulator and wherein the regulator can be sprayed on via a fluidized bed.”
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Non-Final Act. 6 (citing Eisenreich ¶¶ 245–256). Given these teachings, the
Examiner reasoned,
it would have been well within the skill of an ordinary artisan to
optimize the amount of pH regulator to the amount of
solvent/water necessary (specifically the instantly claimed 15-
69.5% of solvent and 30-80% pH regulator) to form to readily
suspend the excipients prior to their spray-drying in a fluidized
or spouted bed as is taught by Seth.
Id.; see also id. at 8 (reasoning that it would have been obvious to optimize
the amounts of pH regulator and solvent to arrive at the amounts of those
components recited in Appellant’s claim 1 (citing In re Aller, 220 F .2d 454,
456, (CCPA 1955))).
The Examiner cited Sharpe as teaching “antifungal compositions with
enhanced bioavailability which utilize buffer solutions of sodium citrate and
citric acid to maintain/stabilize the pH of the formulation.” Non-Final Act. 7
(citing Sharpe 11:20–25).
The Examiner reasoned that it would have been obvious to
incorporate the buffer system of Sharpe and the anti-fungal
active into the method of making carrier pellets of the combined
references in order to develop the method of the instant claims
because it was known in the art that the bioavailability of drugs
is often pH dependent (as is taught by Seth, Eisenreich, and
Sharpe) and wherein it is necessary to stabilize the pH in order
to achieve improved solubility/bioavailability of a drug (i.e. the
antifungal agent of Sharpe or Eisenreich) it was already known
to stabilize the pH for effective oral dosing of the
pharmaceutical actives using citric acid/citrate buffer systems.
Non-Final Act. 9.
Lastly, the Examiner reasoned that, although “Seth and Eisenreich do
not specifically teach that the liquid formulation being sprayed contains 30-
80% of the pH regulator” as recited in Appellant’s claim 1, it would have
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been obvious in a fluidized bed drying process to include the claimed
amounts of pH regulator in the liquid used in the process “because
Eisenreich teaches that the resultant carrier pellets can have the same amount
of pH regulator that is instantly claimed upon evaporation of the liquid,
specifically 50-99%.” Non-Final Act. 9–10.
Analysis—Claim 1
[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 re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); see also In re Jung, 637
F.3d 1356, 1365 (Fed. Cir. 2011) (holding that requiring an applicant to
identify “reversible error” in an examiner’s rejection is consistent with long
standing Board practice).
Having carefully considered all of the evidence and argument
presented by Appellant and the Examiner, we are not persuaded that
Appellant has shown reversible error in the Examiner’s conclusion of
obviousness as to claim 1 in view of the cited references.
In particular, we are not persuaded that, because Seth and Eisenreich
are directed to compositions containing different drugs that have different
formulation concerns, a skilled artisan would not have considered it obvious
to include the amounts of solvent and pH regulator recited in Appellant’s
claim 1 in a liquid introduced into a fluidized bed for preparing spherical
drug carrier pellets. See Appeal Br. 11–15; Reply Br. 8–18.
More particularly, as we understand it, the Examiner’s position is not
that it would have been obvious to increase the amount of pH regulator, in a
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formulation containing Seth’s specific drug, to the amount recited in
Appellant’s claim 1. Rather, the Examiner’s position appears to be that the
formation of pH regulator-containing drug carrier pellets by fluidized bed
drying was known in the art, as evidenced by Seth and Eisenreich, and that a
skilled artisan would have considered it obvious to arrive at the
concentrations of solvent and pH regulator recited in Appellant’s claim 1
through routine optimization, given Eisenreich’s teachings that the amount
of pH regulator may be varied depending on the drug present in formulation:
[T]he examiner has provided a reference which teaches that it
was known in the art to modify/optimize the amount of pH
regulator used in carrier pellets for carrying drugs as the amount
of pH regulator is dependent on which drug or type of drug is to
be carried and delivered via the formulation.
Ans. 11.
Thus, we acknowledge that Seth involves carrier pellets containing a
specific drug, and that Seth only used small amounts of organic acids as pH
regulators, as opposed to the 30 to 80% by weight recited in Appellant’s
claim 1. See Seth ¶ 26 (“The Applicant has discovered, surprisingly, that the
chemical stability of carbidopa can be greatly improved by incorporating
into the formulation a small amount of an organic acid.”); id. ¶ 12
(“According to one embodiment, the organic acid represents from 0.2% to
5% by weight relative to the weight of the composition.”).
Appellant does not persuade us, however, that a skilled artisan would
have failed to recognize from the references cited by the Examiner that the
ranges of pH regulator and solvent recited Appellant’s claim 1 would be
useful in a liquid formulation introduced into a fluidized bed unit for
preparing spherical carrier pellets. See Appeal Br. 16–20; Reply Br. 14–18.
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Specifically, Eisenreich discloses the preparation of “novel
pharmaceutical release systems for basic drugs with pH-dependent water
solubility such as flibanserin.” Eisenreich ¶ 3.
One of Eisenreich’s embodiments “provides a pharmaceutical
controlled release system for administration, particularly oral administration,
of flibanserin, comprising . . . a core material containing or consisting of one
or more pharmaceutically acceptable pH modifiers.” Eisenreich ¶¶ 169–
170.
As the Examiner found, Eisenreich discloses that a number of its
preferred pH modifiers are the same organic acids disclosed in Appellant’s
Specification as being its preferred pH regulators. Compare Eisenreich
¶ 251 (“Particularly preferred organic acids are acetic acid, ascorbic acid,
tartaric acid, glutaric acid, malic acid, fumaric acid, citric acid, lactic acid,
adipic acid and succinic acid or combinations thereof.”) to Spec. ¶ 12
(Appellant’s Specification disclosing citric acid, succinic acid, malic acid,
fumaric acid, tartaric acid, sorbic acid, and adipinic acid among preferred pH
regulators).
As the Examiner found, Eisenreich discloses that the amount and type
of the pH modifier in the core material influences the release of flibanserin
from the core-containing formulation, and type of drug being used in its
formulation influences the choice of pH modifier:
The core material contains at least one pH modifier. The
pH modifier is not limited according to the present invention
but any known chemical substance capable of providing a
modified pH value may be used. Usually the pH modifier may
be selected from one or more organic acids and/or organic bases
and/or buffers or mixtures thereof. The pH modifier is selected
to control the solubility of flibanserin, i.e. the type(s) of pH
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modifier selected and the amount of pH modifier adjusted has
an impact on or triggers the release of flibanserin. Therefore,
the choice of the pH modifier strongly depends from the active
substance(s) to be used.
Eisenreich ¶ 246 (emphasis added).
As the Examiner found, and as recited in Appellant’s claim 1,
Eisenreich discloses that the cores of its formulations may be prepared using
fluidized bed coating:
The pH modifier may be in solid or liquid form. The pH
modifier is not necessarily used in the form of a solid or
mixture of solids but it may be employed in form of a liquid or
mixtures of liquids, for example, by firstly adhering or coating
the pH modifier onto a carrier or carrier particles and then
forming the core containing the pH modifier. For instance, the
adhering or coating can be carried out by a conventional
coating method which is usually used in the preparation of
pharmaceutical preparations, such as fluidized bed coating.”
Eisenreich ¶ 249 (emphasis added).
Eisenreich’s Example 2.1 discloses a process of preparing the cores of
its drug delivery compositions. Eisenreich ¶¶ 571–575.
In Example 2.1, Eisenreich discloses the initial preparation of a 10
part liquid formulation that contains 5 parts by weight of tartaric acid (i.e.,
50% by weight of pH regulator (within the range of 30–80% recited in
Appellant’s claim 1)), 4 parts by weight of water (i.e., 40% by weight of
solvent (within the range of 15–69.5% recited in Appellant’s claim 1)), and
1 part by weight of gum arabic. Eisenreich ¶ 572.
In Example 2.1, Eisenreich’s liquid formulation is introduced into a
“suitable coating apparatus” by spraying (i.e., using a nozzle as recited in
claim 1), and then dried using an air flow at 60–80°C, ultimately producing
“roughly spherical particles,” as recited in Appellant’s claim 1, which are
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discharged from the machine and fractionated according to size. Eisenreich
¶¶ 573–575.
The process described in Example 2.1 of Eisenreich thus differs from
the process of Appellant’s claim 1 only in that Eisenreich does not expressly
state that its “suitable coating apparatus” is a fluidized bed unit as recited in
claim 1. As noted above, however, Eisenreich explicitly teaches that, when
forming its core materials, “coating can be carried out by a conventional
coating method which is usually used in the preparation of pharmaceutical
preparations, such as fluidized bed coating.” Eisenreich ¶ 249.
Accordingly, given Eisenreich’s teaching that a suitable coating
apparatus is useful in the process of preparing core materials described in
Example 2.1, and given Eisenreich’s teaching that fluidized bed coating is a
suitable coating process for preparing its core materials, a skilled artisan
would have had good reason for, and a reasonable expectation of success in,
using a fluidized bed unit in the process taught in Example 2.1 of Eisenreich.
Because using a fluidized bed unit in the process taught in Example 2.1 of
Eisenreich results in a process encompassed by Appellant’s claim 1, we
conclude that the process recited in Appellant’s claim 1 would have been
obvious to a skilled artisan.
Appellant contends that applying the teachings of Example 2.1 in
¶¶ 571–574 of Eisenreich to Seth would not have resulted in a process
recited in Appellant’s claim 1. See Appeal Br. 17; Reply Br. 13–14.
As discussed above, however, the teachings in ¶¶ 571–574 of
Eisenreich by themselves show that concentrations of pH regulator and
solvent encompassed by Appellant’s claim 1 are useful in processes of
preparing pharmaceutical carrier pellets in a fluidized bed unit, as recited in
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claim 1. See Eisenreich ¶ 572–573 (describing spraying into “suitable
coating apparatus” a 10 part liquid formulation containing 5 parts by weight
of tartaric acid (i.e., 50% by weight of pH regulator (within the range of 30–
80% recited in Appellant’s claim 1)) and 4 parts by weight of water (i.e.,
40% by weight of solvent (within the range of 15–69.5% recited in
Appellant’s claim 1)); see also id. ¶ 249 (fluidized bed unit is suitable
coating/drying apparatus).
In sum, for the reasons discussed, Appellant does not persuade us of
reversible error in the Examiner’s conclusion of obviousness as to
Appellant’s representative claim 1 in view of the cited prior art. We
acknowledge that our affirmance does not rely on all of the references cited
by the Examiner. We also acknowledge that our analysis includes citations
to portions of the prior art, and calculations based thereon, not expressly
relied upon by the Examiner. We therefore designate our affirmance of the
Examiner’s rejection of claim 1 as a new ground under 37 C.F.R. § 41.50(b).
Because they were not argued separately, claims 2–8, 12–16, 18–20,
and 35 fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).
Analysis—Claims 37–39
Appellant argues that claims 37–39, which all depend directly or
ultimately from claim 1, are separately patentable from claim 1 because they
narrow the concentration range of the pH regulator used in claim 1’s
process. Appeal Br. 20–21; Reply Br. 18–20. We are not persuaded.
Claim 37 recites “[t]he method according to Claim 1; wherein the
liquid formulation contains 41 to 80% by weight of the at least one pH
regulator.” Appeal Br. 31.
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As noted above, the 10 part liquid formulation used for preparing
Eisenreich’s spherical cores contains 5 parts by weight of tartaric acid (i.e.,
50% by weight of pH regulator), which is within the range of 41–80%
recited in Appellant’s claim 37. Eisenreich ¶ 572. Moreover, given the
teachings in Eisenreich’s Example 2.1, discussed above, Appellant does not
persuade us that “no actual method of obtaining these cores is set forth.”
Appeal Br. 20.
Because Appellant does not persuade us, therefore, that the Examiner
erred in concluding that the process recited in Appellant’s claim 37 would
have been obvious, we affirm the Examiner’s rejection of claim 37. Claims
38 and 39 fall with claim 37 because they were argued in the same claim
grouping. See 37 C.F.R. § 41.37(c)(1)(iv). For reasons similar to those
discussed above, we designate our affirmance a new ground of rejection
under 37 C.F.R. § 41.50(b).
Analysis—Claim 40
Appellant’s claim 40 reads as follows:
Claim 40: The method according to Claim 1;
wherein the liquid formulation further comprises at least
one binder; and
wherein the liquid formulation has a ratio of total pH
regulator to total binder of 50:50 to 99:1 so that the carrier
pellets have a have a total pH regulator amount of 50 to 99%
after the solvent is evaporated by the drying gas flow.
Appeal Br. 32.
Appellant argues that “[t]here is no teaching in Seth—the only
reference cited for the claimed method steps and thus relevant to the
composition of a liquid formulation for use in a fluidized bed-that would
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lead a person of ordinary skill in the art to arrive at the liquid formulation of
claim 40.” Appeal Br. 21; see also Reply Br. 20–21.
As discussed above, however, Eisenreich discloses that the liquid
formulation used to prepare its spherical cores contains 5 parts tartaric acid
(pH regulator) and 1 part gum arabic (binder), which is a ratio of pH
regulator to binder that falls within the ratio range recited in Appellant’s
claim 40. See Eisenreich ¶ 572. We are not persuaded, therefore, that the
cited prior art fails to suggest preparing a liquid formulation encompassed by
claim 40, for introduction into a fluidized bed unit, to produce
pharmaceutical carrier pellets.
To be complete, we note that Eisenreich discloses combining its liquid
formulation with 8.3 parts tartaric acid particles and 6.7 parts powdered
tartaric acid in the coating apparatus, which would result in a 21 total-part
formulation (1 part gum arabic + (5 + 8.3 + 6.7 parts tartaric acid)) after
water removal. See Eisenreich ¶¶ 572–573.
Because 1 part gum arabic and 20 parts tartaric acid in a 21 total-part
formulation are about 4.8% and 95.2% of binder and pH regulator
respectively, we find that Eisenreich suggests preparing, in a fluidized bed
unit, not only the liquid formulation in Appellant’s claim 40, but also the
final product recited in the claim. Accordingly, we affirm the Examiner’s
rejection of claim 40. For reasons similar to those discussed above, we
designate our affirmance a new ground of rejection under 37 C.F.R.
§ 41.50(b).
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OBVIOUSNESS—
SETH, EISENREICH, SHARPE, BILLOTTE,
AND TWARDZIK
The Examiner’s Prima Facie Case
In rejecting claims 9–11, the Examiner relied on the teachings in Seth,
Eisenreich, and Sharpe noted above, and cited Billotte and Twardzik as
evidence that the additional features recited in claims 9–11, which all
depend directly or ultimately from claim 1, would have been obvious
features of the process suggested by in Seth, Eisenreich, and Sharpe. Non-
Final Action 10–12.
Analysis
In traversing the Examiner’s rejection of claims 9–11, Appellant relies
on the arguments advanced against the rejection of claim 1. See Appeal Br.
22. For the reasons discussed above, we do not find those arguments
persuasive. We therefore affirm the Examiner’s rejection of claims 9–11 for
obviousness. For reasons similar to those discussed above, we designate our
affirmance a new ground of rejection under 37 C.F.R. § 41.50(b).
OBVIOUSNESS—
SETH, EISENREICH, SHARPE, RUPP,
AND JACOB
The Examiner’s Prima Facie Case
In rejecting claims 21–23, the Examiner relied on the teachings in
Seth, Eisenreich, and Sharpe noted above, and cited Rupp and Jacob as
evidence that the additional features recited in claims 21–23, which all
depend directly or ultimately from claim 1, would have been obvious
features of the process suggested by in Seth, Eisenreich, and Sharpe. Non-
Final Action 12–15.
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Analysis
In traversing the Examiner’s rejection of claims 21–23, Appellant
relies on the arguments advanced against the rejection of claim 1. See
Appeal Br. 22–23. For the reasons discussed above, we do not find those
arguments persuasive. We therefore affirm the Examiner’s rejection of
claims 21–23 for obviousness. For reasons similar to those discussed above,
we designate our affirmance a new ground of rejection under 37 C.F.R.
§ 41.50(b).
OBVIOUSNESS—
SETH, EISENREICH, SHARPE,
AND UHLEMANN
The Examiner’s Prima Facie Case
In rejecting claims 33 and 34, the Examiner relied on the teachings in
Seth, Eisenreich, and Sharpe noted above, and cited Uhlemann as evidence
that the additional features recited in claims 33 and 34, both of which
depend from claim 1, would have been obvious features of the process
suggested by in Seth, Eisenreich, and Sharpe. Non-Final Action 15–16.
Analysis
In traversing the Examiner’s rejection of claims 33 and 34, Appellant
relies on the arguments advanced against the rejection of claim 1. See
Appeal Br. 23. For the reasons discussed above, we do not find those
arguments persuasive. We therefore affirm the Examiner’s rejection of
claims 33 and 34 for obviousness. For reasons similar to those discussed
above, we designate our affirmance a new ground of rejection under 37
C.F.R. § 41.50(b).
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OBVIOUSNESS—
SETH, EISENREICH, SHARPE,
AND JORGENSEN
The Examiner’s Prima Facie Case
In rejecting claims 36 and 41, the Examiner relied on the teachings in
Seth, Eisenreich, and Sharpe noted above, and cited Jorgensen as evidence
that the additional features recited in claims 36 and 41, both of which
depend from claim 1, would have been obvious features of the process
suggested by in Seth, Eisenreich, and Sharpe. Non-Final Action 17–18.
In particular, the Examiner cited Jorgensen as teaching that it was
known in the art to
formulate carrier pellets which do not contain the drug within
the pellet, but where the drug could be sprayed onto an already
formed pellet as such it reads on the instant process wherein the
pellets are formed in an empty fluidized-bed via spraying/spray-
drying without the drug and then subsequently coated in a
fluidized bed with active agents, etc. (See entire document: e.g.
[0001]; Claim 1; [00041; [0006-0007]; [0010). I.e. the drug can
be applied after the formulation of the pellets via the method of
Seth and their removal from fluidized-bed or spouted-bed.
Non-Final Act. 17.
Based on the cited references’ combined teachings the Examiner
reasoned that it would have been obvious that the “carrier pellets of Seth
could also be formed without active drug and be coated with the drugs after
the carrier pellets are formed in an empty spouted- or fluidized-bed and
made only of carrier and pH regulator/excipients as is taught by Jorgensen.”
Non-Final Act. 18.
The Examiner reasoned that a skilled artisan had motivation for
forming pellets in the manner recited by claims 36 and 41, “[e]specially
since this would allow for many carrier pellets to be made ahead of time and
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coated as necessary with the desired active agent in a very quick manner for
subsequent sale and use.” Non-Final Act. 18.
Analysis—Claim 36
Appellant’s claim 36 recites “[t]he method according to Claim 1;
wherein no pharmaceutically active substance is fed into the fluidized-bed or
spouted-bed unit so that the carrier pellets discharged from the unit contain
no pharmaceutically active substance.” Appeal Br. 31.
As seen above, Eisenreich discloses that, when preparing the spherical
cores for its drug-carrying compositions, Eisenreich feeds only tartaric acid
(pH regulator), water (solvent), and gum arabic (binder) into its drying
apparatus. See Eisenreich ¶¶ 571–574.
Appellant does not persuade us, therefore, that none of the cited
references suggests performing the process of Appellant’s claim 36. See
Appeal Br. 23–24; Reply Br. 23–24. Accordingly, we affirm the
Examiner’s rejection of claim 36 for obviousness. For reasons similar to
those discussed above, we designate our affirmance a new ground of
rejection under 37 C.F.R. § 41.50(b).
Analysis—Claim 41
Appellant’s claim 41 recites “[t]he method according to Claim 1;
wherein, in step b), the fluidized-bed or spouted-bed unit is empty so that the
carrier pellets are formed in step c) from only the liquid formulation.”
Appeal Br. 32.
Appellant contends that, because both Seth and Eisenreich teach that
solid materials such as powders should be included in fluidized bed dryers
when making drug carrier pellets, the cited prior art does not suggest claim
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41’s method, in which the fluidized bed is empty when the liquid
formulation is introduced into it. Appeal Br. 25–26; Reply Br. 25–26.
The Examiner “respectfully disagrees because Jorgensen teaches
spray drying pellets, e.g. spraying the pellet forming mixture into a fluidized
bed to form the pellets and further applying any coatings to the pellets in the
fluidized bed.” Ans. 15. Thus, the Examiner contends, Jorgensen teaches
that “the powder used in the fluidized bed prior to spraying of Seth is not
necessary for forming the carrier pellets, and as such carrier pellets can be
made without this step if desired, e.g. if the drug is going to be added as a
coating after carrier pellet formation.” Id.
In this instance, we do not find that the preponderance of the evidence
supports the Examiner’s position. We acknowledge Jorgensen’s disclosure
of producing drug carrier pellets by spray-drying a liquid composition
containing a cellulosic binder and an inert particulate carrier. See Jorgensen
¶ 9; see also id. ¶ 33 (describing spray-drying apparatus).
The Examiner, however, does not identify, nor do we discern, any
teaching, suggestion, or disclosure in Jorgensen of spraying a pellet-forming
liquid into a fluidized bed unit as recited in Appellant’s claim 41. Rather,
Jorgensen describes introducing the already-formed pellets into the fluidized
bed unit for subsequent coating. See Jorgensen ¶ 41. We are not persuaded,
therefore, that the Examiner has explained sufficiently why the combined
teachings of Jorgensen, Seth, and Eisenreich would have suggested the
process recited in Appellant’s claim 41. Accordingly, we reverse the
Examiner’s rejection of claim 41 for obviousness.
Appeal 2020-001723
Application 14/209,056

19
CONCLUSION
For the reasons discussed, we affirm all of the Examiner’s rejections
except for the rejection of Appellant’s claim 41. As noted above, however,
because our affirmance relies on a rationale somewhat different from the
Examiner’s, we designate our affirmance a new ground of rejection under 37
C.F.R. § 41.50(b).
DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed New
Ground
1–8, 12–
16, 18–
20, 35,
37–40
103(a) Seth, Eisenreich,
Sharpe
1–8, 12–
16, 18–
20, 35,
37–40
1–8, 12–
16, 18–
20, 35,
37–40
9–11 103(a) Seth, Eisenreich,
Sharpe, Billotte,
Twardzik
9–11 9–11
21–23 103(a) over Seth,
Eisenreich, Sharpe,
Rupp, Jacob
21–23 21–23
33, 34 103(a) Seth, Eisenreich,
Sharpe, Uhlemann
33, 34 33, 34
36, 41 103(a) Seth, Eisenreich,
Sharpe, Jorgensen
36 41 36
Overall
Outcome
1–16, 18–
23, 33–40
41 1–16,
18–23,
33–40

Appeal 2020-001723
Application 14/209,056

20
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides “[a] new ground of
rejection pursuant to this paragraph shall not be considered final for judicial
review.”
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .
(2) Request rehearing. Request that the proceeding be
reheard under §41.52 by the Board upon the same Record. . . .

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01 (9th Ed., Rev.
10.2019, June 2020).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv) (2019).
AFFIRMED; 37 C.F.R. § 41.50(b)