FUISZ, Richard C.

Patent Trials and Appeals Board

Aug 30, 2019

12249456 - (D) (P.T.A.B. Aug. 30, 2019)

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.
12/249,456 10/10/2008 Richard C. FUISZ 20437-136190-US 1764
42798 7590 08/30/2019
FITCH, EVEN, TABIN & FLANNERY, LLP
120 South LaSalle Street, Suite 2100
Chicago, IL 60603-3406
EXAMINER
GHALI, ISIS A D
ART UNIT PAPER NUMBER
1611
MAIL DATE DELIVERY MODE
08/30/2019 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 RICHARD C. FUISZ1
____________

Appeal 2019-003774
Application 12/249,456
Technology Center 1600
____________

Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The claims in this appeal are directed to an extruded bioactive product
comprising a sheet made by hot melt extruding a nonaqueous composition.
The Examiner rejected the claims under 35 U.S.C. § 103 as obvious.
Pursuant to 35 U.S.C. § 134, Appellant appeals the Examiner’s
determination that the claims are unpatentable. We have jurisdiction for the
appeal under 35 U.S.C. § 6(b). The Examiner’s decision is affirmed.

1 The Appeal Brief (“Appeal Br.” entered Dec. 17, 2018) identifies Philip
Morris Products S.A. of Neuchatel, Switzerland as the real party in interest.
Appeal Br. 1.
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STATEMENT OF THE CASE
Claims 30, 31, 34, 35, 37, 39, 41–43, 46, 48, 49, 55–61, 66, 68–70,
and 127–130 stand finally rejected by the Examiner as follows:
1. Claims 30, 31, 34, 35, 37, 39, 41–43, 46, 48, 49, 57–61, 66, 68–70,
and 127–130 under pre-AIA 35 U.S.C. § 103(a) as obvious over any of
McGinity et al. (US 2001/0006677 A1, published July 5, 2001)
(“McGinity”), Jannusch et al. (US 2005/0208108 A1, published Sept. 22,
2005) (“Jannusch”), or Schiraldi et al. (US 4,713,243, issued Dec. 15, 1987)
(“Schiraldi”), each in view of Sohi et al. (Harmik Sohi et al., Taste Masking
Technologies in Oral Pharmaceuticals: Recent Developments and
Approaches, 30(5) DRUG DEV. & INDUST. PHARMACY 429–48 (2004))
(“Sohi”) and “as evidenced” by Amberlite (Amberlite™ IRP69
Pharmaceutical Grade Cation Exchange Resin (Sodium Polystyrene
Sulfonate USP), Rohm & Haas 1–5 (2006), https://nshosting.dow.com/doc-
rchive/business/process_chemicals/amberlite_and_duolite_pharmaceutical
_grade_resins/amberlite_irp69/tds/amberlite_irp69.pdf) (“Amberlite”).
Final Act. 4.
2. Claims 55 and 56 under pre-AIA 35 U.S.C. § 103(a) as obvious
over any of McGinity, Jannusch or Schiraldi, each in view of Sohi, and
further in view of Yang et al. (US 2005/0037055 A1, published Feb. 17,
2005) (“Yang”). Final Act. 9.
Claim 30, which is representative of the appealed subject matter, is
reproduced below (indenting has been added to clarify certain individual
limitations of the claim):
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30. An extruded bioactive product comprising
a sheet made by hot melt extruding a nonaqueous
composition comprising at least one thermoplastic polymer and
a bioactive agent other than tobacco,
the bioactive agent including an ion exchange resin,
the sheet comprising a matrix comprising the at least one
thermoplastic polymer and the bioactive agent including the ion
exchange resin distributed in the matrix, and
the matrix being soluble on the mucosa of a user and
resulting in sustained release of the bioactive agent to the user.

REJECTION 1
The Examiner found that each of McGinity, Jannusch, and Schiraldi
describes the elements of all the independent claims (Final Act. 4–7), but not
a taste masking agent which is an “ion exchange resin” as recited in the
claims (Final Act. 7). To meet this deficiency, the Examiner cited Sohi
which the Examiner found “teaches known taste masking technologies to
reduce bitterness of oral drugs and . . . improve their palatability” and
promote “better compliance and acceptability by patients.” Id. The
Examiner further found that Sohi describes ion exchange resins as taste
masking agents, including Amberlite which is “the most preferred ion
exchange resin used by applicants as taste masking agent.” Id. The
Examiner found it obvious to one of ordinary skill in the art to have used an
ion exchange resin in the extruded films described by each of McGinity,
Jannusch, and Schiraldi because these latter publications teach using taste
masking agents or flavors and Sohi teaches that “taste masking agents
including ion exchange resins reduce bitterness of oral drugs to improve
their palatability and that translates to better compliance and acceptability by
patients.” Id. at 8.
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Appellant contends that Sohi “does not disclose the use of ion
exchange resin in films, or suggest the feasibility or desirability of using ion
exchange resin in films, let alone films made by non-aqueous hot melt
extrusion.” Appeal Br. 9. Appellant states that “Sohi solely discusses the
use of ion exchange resins in oral liquid products.” Id.
To support this argument, Appellant provided two declarations by
Robert K. Yang, Ph.D., who states that that he has “experience and
expertise” in the field of the claimed subject matter, including thin film drug
delivery. Yang 1 Declaration (dated Dec. 5, 2015) (“Yang 1 Decl.”); Yang 2
Declaration (dated Feb. 21, 2018) (“Yang 2 Decl.”).
Discussion
The main issue in this rejection is whether it would have been obvious
to one of ordinary skill in the art to use the ion exchange resin described by
Sohi in a “sheet comprising a matrix comprising the at least one
thermoplastic polymer and the bioactive agent” as recited in claim 1.
It is true, as asserted by Appellant, that Sohi does not expressly
disclose taste masking agents in films for oral use, or, more specifically,
using an ion exchange resin in a film made by hot melt extrusion as recited
in the claims. Appeal Br. 9. However, the Examiner did not reply upon
Sohi to supply this teaching. Instead, the Examiner found that McGinity,
Jannusch, and Schiraldi provided a reason to use the ion exchange resin of
Sohi as a taste masking agent in a film (“sheet” as claimed).
For example, Jannusch teaches that a “masking agent” can be “present
in a film intended for oral use . . . designed to mask an undesirable taste.”
Jannusch ¶ 88. McGinity also discloses that the “combination of the
effervescent film with other ingredients can provide effective taste masking
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of particularly poor tasting compounds.” McGinity ¶ 18. Each of these
teachings provide a reason to have used a taste masking technology
described in Sohi because the latter describe the benefit of such an agent in
masking undesirable tastes. Sohi identifies taste masking technology to
“improve[] palatability” and impart “bitter drugs with an acceptable degree
of palatability.” Sohi 429 (Abstract). While Sohi does not expressly
disclose using an ion exchange resin in a hot melt extruded sheet as claimed,
it is not necessary to identify an express teaching when Jannusch and
McGinity, which describe hot extruded sheets, suggest the use of taste
masking agents, and Sohi teaches such agents, including the claimed one.
Dr. Yang states that none of McGinity, Jannusch, or Schiraldi
provides any motivation to combine their teachings with Sohi (Yang 2 Decl.
6), but he did not address the teaching in Jannusch and McGinity about
using a taste masking agent in film, providing an express reason to look to
the taste masking technology in Sohi to identify a suitable taste masking
agent.
Dr. Yang states the ordinarily skilled worker “would have perceived
substantial barriers to the . . . successful inclusion of ion exchange drug
complexes in a hot melt extruded film composition, because of the heat and
intense shear forces involved in hot melt extrusion.” Yang 1 Decl. 5. Dr.
Yang further explains:
Ion exchange resin complexes, such as nicotine polacrilex, are
understood to use weak ionic bonds. Moreover, temperature
degradation is a known concern that has disfavored the use of
hot melt extrusion for temperature sensitive actives. The
successful incorporation of ion exchange drug complexes in hot
melt extruded films by the instant Fuisz application is – to me –
a surprising result.
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Yang 1 Decl. 5.
Dr. Yang further provided evidence in his second declaration of
“high” shear rates, and repeated again that the “successful incorporation of
ion exchange drug complexes in hot melt extruded films” is surprising to
him. Yang 2 Decl. 7.
Dr. Yang’s testimony does not persuade us that the Examiner erred.
While Dr. Yang states that he was surprised that ion exchange drug
complexes could be successfully subjected to “the heat and intense shear
forces involved in hot melt extrusion” (Yang 1 Decl. 5), as explained below,
he does not provide adequate reasoning for his surprise.
He identifies the presence of “weak ionic bonds” in ion exchange
resins, but does not explain why their presence would have led the skilled
worker to doubt that “bioactive agents including an ion exchange resin” as
claimed could be incorporated into the matrix of a sheet made by hot melt
extrusion. Yang 1 Decl. 4–5. In making this argument Dr. Yang refers to
the bioactive agent (“drug”) as in a “complex” with the resin, but the claims
do not recite that a complex is present and Dr. Yang does not explain why a
“complex” is required by the claims. Id. Thus, we find that Dr. Yang is
reading a limitation into the claims.
Dr. Yang also identified temperature degradation as a concern for
“temperature sensitive actives.” Yang 1 Decl. 5. However, the claims are
not limited to temperature sensitive actives and each of McGinity, Jannusch,
and Schiraldi discloses “actives” which are subjected to hot melt extrusion.
Thus, they would have been subjected to the “heat and intense shear forces”
described by Dr. Yang as a “substantial barrier” to including the
“complex” in the sheet made by hot melt extrusion. Id. Therefore, Dr.
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Yang’s argument is not commensurate with the full scope because the claims
includes bioactive agents which are described in the cited prior art
publications to be useful in hot melt extruded films. See, e.g., McGinity ¶
62; Jannusch ¶¶ 95–103.
Dr. Yang did not provide evidence that one of ordinary skill in the art
would have considered the ion exchange matrix described in Sohi to be
sensitive to the temperatures and shear force involved in hot melt extrusion.
Thus, Dr. Yang’s statement is not supported by adequate objective scientific
evidence. See CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342
(Fed. Cir. 2003).
McGinity specifically mentions the temperature degradation issues in
hot melt extrusion and describes a need for improvement:
Hot-melt extrusion processes in the art have generally required
extremely elevated temperatures (>150° C.). These
temperatures could degrade extruded materials such as those
that combine to form an effervescent composition. A need
continues to exist in the art for improved effervescent film
preparations useful in a hot-melt extrusion process.
McGinity ¶ 15.
McGinity describes using temperatures for hot melt extrusion that do
not exceed 150°C, and preferably which do not exceed 120°C. McGinity
¶ 101. Dr. Yang did not address this disclosure in McGinity, although it is
among the list of publications he studied. Yang 2 Decl. 4.
While Dr. Yang focuses on Sohi’s lack of a teaching of a film, or a
hot melt extruded film, Dr. Yang offered no persuasive explanation as to
why this deficiency, alone, would have led the skilled worker to believe the
disclosed ion exchange resin would be unsuitable for this purpose.
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Dr. Yang also states that “[n]othing in McGinity suggests that the
taste masking options proposed by McGinity had drawbacks that warranted
the need to look toward alternative methods of altering the perceived taste of
an active agent.” Yang 1 Decl. 6.
McGinity generally suggests taste masking agents in a film.
McGinity ¶ 18. Jannusch also discloses using a taste masking agent in an
oral film. Jannusch ¶ 88. Neither of these disclosure are limited to a
specific masking agent. Thus, one of ordinary skill in the art would have
routinely looked to the taste masking technology to identify agents that
perform this function, such as those described in Sohi.
With respect to Dr. Yang’s statement that “[t]he successful
incorporation of ion exchange drug complexes in hot melt extruded films by
the instant Fuisz application is – to me – a surprising result” (Yang 2 Decl.
7), as discussed above, the claims do not recite the presence of “drug
complexes.”
In sum, while we have considered both Yang declarations and
Appellant’s arguments, we are not persuaded that one of ordinary skill in the
art would not have had reason to use the ion exchange resin described in
Sohi in a hot melt extruded film. Dr. Yang did not provide persuasive
evidence that the characteristics of the ion exchange resin of Sohi would
have made it unsuitable for hot melt extrusion when combined with a
bioactive agent; he did not adequately address the disclosure in each of
McGinity, Jannusch, and Schiraldi describing active agents useful in hot
melt extruded films; and he did not discuss the specific disclosure in
McGinity in which the high temperature concern was recognized and
addressed.
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Claim 35
Claim 35 depends from claims 34 and 30, and requires that the sheet
has a rectangular shape and a thickness of 10 to 50 mils. The Examiner
found that Jannusch describes a film of 39.37 mil thickness, a value that falls
within the claimed range. Final Act. 6. Appellant contends “there would
not have been any apparent reason to apply the film thickness in Jannusch to
the proposed combination of McGinity, Jannusch or Schiraldi, and Sohi et
al.” Appeal Br. 11. This argument is not persuasive because Jannusch
teaches that such thickness is suitable in a film.

Claims 128 and 130
Claims 128 and 130 are directed to an extruded hot melt product as in
claim 30, but exclude the film from being effervescent. Appellant argues the
teachings of McGinity “only relate to . . . effervescent controlled release
water soluble or swellable hot-melt extruded films” and do not provide a
product that is not effervescent as claimed. Appeal Br. 11.
As discussed by the Examiner, Jannusch and Schiraldi “are not
effervescent films,” and the Examiner found that each describes films with
all the limitations of the claims when combined with Sohi. Ans. 16.

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Summary
For the foregoing reasons, the obviousness rejection of claims 30, 35,
128, and 130 is affirmed for the reasons set forth by the Examiner and as
discussed above. Claims 31, 34, 37, 39, 41–43, 46, 48, 49, 57–61, 66, 68–
70, 127, and 129 were not separately argued and fall with claims 30, 35, 128,
and 130. See 37 C.F.R. § 41.37(c)(1)(iv).

REJECTION 2
The Examiner found that claims 55 and 56 would have been further
obvious in view of Yang. Final Act. 10–11. Appellant relied on the same
arguments as for Rejection 1. Accordingly, the rejection of these claims is
affirmed for the same reasons.

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)(1)(iv).

AFFIRMED