Ex Parte Rossi

Patent Trial and Appeal Board

Jun 20, 2017

13014273 (P.T.A.B. Jun. 20, 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.
13/014,273 01/26/2011 Massimiliano ROSSI 374974US99 1288
22850 7590 06/22/2017
OBLON, MCCLELLAND, MAIER & NEUSTADT, L.L.P.
1940 DUKE STREET
ALEXANDRIA, VA 22314
EXAMINER
PERREAULT, ANDREW D
ART UNIT PAPER NUMBER
3788
NOTIFICATION DATE DELIVERY MODE
06/22/2017 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):
patentdocket @ oblon. com
oblonpat @ oblon. com
tfarrell@oblon.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MASSIMILIANO ROSSI
Appeal 2015-001579
Application 13/014,2731
Technology Center 3700
Before MICHAEL C. ASTORINO, PHILIP J. HOFFMANN, and
KEVIN W. CHERRY, Administrative Patent Judges.
ASTORINO, Administrative Patent Judge.
DECISION ON APPEAL
The Appellant appeals under 35 U.S.C. § 134 from the Examiner’s
decision finally rejecting claims 1—7, 9-14, 16—22, and 35. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b). An oral hearing was
held on May 16, 2017.
We REVERSE.
1 According to the Appellant, the real party in interest is E-Pharma Trento
S.P.A. Appeal Br. 1.
Appeal 2015-001579
Application 13/014,273
STATEMENT OF THE CASE
Claimed Subject Matter
The Appellant’s invention is directed “to a strengthened blister pack
for the packaging of solid pharmaceutical forms and/or food supplements”
and specifically, “a new blister pack for the packaging of solid
pharmaceutical forms and/or food supplements that are not very hard and are
highly friable.” Spec. 1:4—8. Claim 1, the sole independent claim, is
representative of the subject matter on appeal and is reproduced below.
1. A blister pack comprising at least a first thermo formed layer,
a top layer, which seals and covers a top surface of said first
thermoformed layer, and a shaped layer, which seals and covers
a bottom surface of said blister pack, wherein said first
thermoformed layer comprises a reinforcing system comprising
a removable capsule that is removable from the first
thermoformed layer.
Rejections
I. Claim 35 stands rejected under 35 U.S.C. § 112, first paragraph,
as failing to comply with the enablement requirement.
II. Claim 35 stands rejected under 35 U.S.C. § 112, second
paragraph, as being indefinite.
III. Claims 1—7, 16—18, and 35 are rejected under 35 U.S.C.
§ 102(b) as anticipated by or, in the alternative, 35 U.S.C. § 103(a) as
unpatentable over Kalvelage et al. (US 7,828, 149 B2, iss. Nov. 9, 2010)
(hereafter “Kalvelage”).
IV. Claims 2—5 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kalvelage and Benavides (US 2009/0057183 Al, pub.
Mar. 5, 2009).
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Application 13/014,273
V. Claims 2—5 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kalvelage and Ewing (US 5,236,749, iss. Aug. 17, 1993).
VI. Claims 2—5 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kalvelage and Hession (US 7,401,702 B2, iss. July 22,
2008).
VII. Claims 9—14 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kalvelage and Blum et al. (US 2005/0077202 Al, pub.
Apr. 14, 2005) (hereafter “Blum”).
VIII. Claims 19-22 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Kalvelage and Pasbrig et al. (US 7,854,225 B2, iss.
Dec. 21, 2010) (hereafter “Pasbrig”).
ANALYSIS
Rejection I
The Examiner rejects dependent claim 35 as failing to comply with
the enablement requirement because the claim contains subject matter that
was not described in the specification in such a way as to enable one of
ordinary skill in the art to make and/or use the invention. Final Act. 2. In
particular, the Examiner identifies the added limitation of claim 35, i.e.,
“wherein the removable capsule of the reinforcing system is rigid and the
first thermoformed layer is otherwise flexible,” as lacking enablement. Id.
The Examiner supports this rejection by finding that the original
specification discloses that the removable capsule and the first
thermoformed layer are made of the same material, and “does not describe
how the same material is both rigid and flexible.” Id.
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Application 13/014,273
The Appellant argues that the enablement rejection should not be
sustained. Appeal Br. 24 (citing Spec. 4—5, 9-10; Fig. 6). The Appellant
argues that “it is the thermoforming that creates the rigid removable capsule
in the otherwise flexible first thermoformed layer.” Appeal Br. 24.
Specifically, the Appellant asserts that “[t]he specification describes with
reference to Fig. 6 four stages in which the first thermoformed layer is
formed.2 And, particularly point to “stage (III),” which is described as
“producing . . . thermoformed layer 7 by thermoforming at least one capsule
in . . . sheet 20.” Id.', Spec. 9:29—20, 10:4—5, Fig. 6. The Specification also
describes “[pjreferably thermoforming stage (III) is carried out using a
mould 22 fitted with shaped punches 22a.” Spec. 10:22—23. We agree with
the Appellant. See Transcript 8—9 (mailed June 14, 2017).
Further, we note that the Examiner does not respond to the
Appellant’s argument in the Answer. See Reply Br. 6. And, the Examiner’s
rejection fails to explain why the disclosure, as filed, is not sufficiently
complete to enable one of ordinary skill in the art to make and use the
claimed invention without undue experimentation. See U.S. v. Telectronics,
Inc., 857 F.2d 778, 785 (Fed. Cir. 1988). Determining whether any
necessary experimentation is undue involves considering relevant factors
including, but not limited to: (1) the quantity of experimentation necessary;
(2) the amount of direction or guidance presented; (3) the presence or
absence of working examples; (4) the nature of the invention; (5) the state of
2 Stage (I) is described as “providing and unrolling a coil 19 of polymer
sheet 20 to form thermoformed layer 7,” and stage (II) is described as
“heating said polymer sheet 20,” “[pjreferably stage (II)... is carried out in
three consecutive steps, by means of three adjacent plates 21, up to a
temperature of 120°[-]140°C.” Spec. 10: 1-3, 19-21.
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Application 13/014,273
the prior art; (6) the relative skill of those in the art; (7) the predictability or
unpredictability of the art; and (8) the breadth of the claims. In re Wands,
858 F.2d 731, 737 (Fed. Cir. 1988); see MPEP § 2164.01. The Examiner’s
rejection does not discuss many of the factors set forth in Wands as they
relate to undue experimentation. Although the Examiner is not required to
provide a discussion as to every Wands factor, it is not apparent from the
Final Office Action or the Answer that many of these factors have been
considered. Based on the foregoing, we determine that the Examiner’s
rejection under 35 U.S.C. § 112, first paragraph, as failing to comply with
the enablement requirement, is not sufficiently complete to establish a prima
facie case. Thus, we do not sustain the rejection of claim 35 under 35
U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the
enablement requirement.
Rejection II
The Examiner rejects dependent claim 35 as indefinite because the
term “otherwise” in “wherein the removable capsule of the reinforcing
system is rigid and the first thermoformed layer is otherwise flexible” is not
clear. See Final Act. 3. According to the Examiner, there is an apparent
confusion in the record “as to the intent of the wording ‘otherwise’ (i.e. is
the layer flexible or not flexible?)”. Id. For similar reasons as discussed
above, we determine that the term “otherwise” in the aforementioned
limitation of claim 35 does not make the claim indefinite. See Appeal
Br. 25.
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Application 13/014,273
Rejection III
Independent claim 1 recites:
A blister pack comprising at least a first thermoformed layer, a
top layer, which seals and covers a top surface of said first
thermoformed layer, and a shaped layer, which seals and covers
a bottom surface of said blister pack, wherein said first
thermoformed layer comprises a reinforcing system comprising
a removable capsule that is removable from the first
thermoformed layer.
Appeal Br., Claims App. The Examiner finds that Kalvelage’s optional
ridge 32 corresponds to the claimed “capsule.” Final Act. 4. The Appellant
argues that optional ridge 32 is not a capsule as required by independent
claim 1. See Appeal Br. 2—6; Reply Br. 2. Based on the foregoing, an issue
that is required to be resolved in this case is the meaning of the term
“capsule.” See Transcript 4.
We determine the scope of the claims in patent applications not solely
on the basis of the claim language, but upon giving claims “their broadest
reasonable interpretation consistent with the specification” and “in light of
the specification as it would be interpreted by one of ordinary skill in the
art.” In re Am. Acad. ofSci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004)
(citations omitted).
The Specification uses the term “capsule” in two different ways in the
Specification: first, as referring to a pharmaceutical form (e.g., a tablet); and
second, as a structure that is designed for a pharmaceutical form to be
positioned therein. See Spec. 1: 4—5, 19—22; 9:13—20; 11:24—25; 12: 10-11;
18: 26 — 19:5, fig. 3. The Appellant agrees that the Specification uses term
“capsule” in these two different ways. See Transcript 7—8. The second use
of the term “capsule” is depicted in Figures 1 and 3, where pharmaceutical
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form 9 is positioned in capsule 10; and capsule 10 is used to break top layer
6 making it possible for pharmaceutical form 9 to be expelled from blister
pack 1. See Spec. 9:13—20. Based on the context of the term “capsule” in
claim 1, the meaning of the term “capsule” in the claim refers to the second
use of the term. See Transcript 7—8.
Based on the foregoing, we do not understand Kalvelage’s optional
ridge 32 to correspond to the claimed “capsule.” Here, Kalvelage’s
disclosure does not adequately support a finding that optional ridge 32 is a
structure that is designed for a pharmaceutical form to be positioned therein.
Rather, optional ridge 32 is designed “as frictional engagement points to seal
each recess 24 when lid sheet 14 is placed into an overlying relationship
with blister sheet 16.” Kalvelage, col. 4,11. 40-42 (emphasis omitted); see
id. at col. 4,11. 43^44.
Thus, we do not sustain the Examiner’s rejection of independent
claim 1, and claims 2—7, 16—18, and 35 which depend therefrom, as
anticipated by or unpatentable over Kalvelage.
Rejections IV—VIII
The remaining rejections based on Kalvelage in combination with
Benavides, Ewing, Hession, Blum, or Pasbrig rely on the same inadequately
supported finding as discussed above. The inadequately supported finding is
not otherwise cured by additional findings and/or reasoning in the remaining
rejections. As such, we do not sustain the rejections under 35 U.S.C.
§ 103(a) of claims 2—5, 9-14, and 19-22.
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DECISION
We REVERSE the Examiner’s decision rejecting claims 1—7, 9—14,
16—22, and 35.
REVERSED
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