Ex Parte McClain et al

Patent Trial and Appeal Board

May 16, 2016

12871101 (P.T.A.B. May. 16, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/871,101 08/30/2010
44001 7590 05/18/2016
Marshall, Gerstein & Bornn LLP (Baxter)
233 South Wacker Drive
6300 Willis Tower
Chicago, IL 60606-6357
FIRST NAMED INVENTOR
Kimberly A. McClain
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.
31203/42719B 1155
EXAMINER
POON, ROBERT
ART UNIT PAPER NUMBER
3788
NOTIFICATION DATE DELIVERY MODE
05/18/2016 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):
mgbdocket@marshallip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KIMBERLY A. MCCLAIN, MICHAEL BAKL YCKI,
and THOMAS D. MCDEVITT
Appeal2014-006053
Application 12/871, 101
Technology Center 3700
Before JOHN C. KERINS, JAMES P. CALVE, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellants 1 appeal under 35 U.S.C. § 134(a) from the Examiner's
decision rejecting claims 1-11. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We REVERSE.
1 Appellants submit the real parties in interest are Baxter International, Inc.
and Baxter Healthcare SA. Appeal Br. 2.
Appeal2014-006053
Application 12/871, 101
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A packaging system comprising:
a glass vial including a wall defining a lower closed end
and an upper open end, the wall having an outer surface, an
inner surface defining a receptacle, a flange-like rim disposed
about the open end, and a neck of reduced diameter between the
closed end and the rim below the rim;
a pharmaceutical product disposed in the receptacle, the
product selected from the group of pharmaceutical products
consisting of adrenergic agontists, adrenergic antagonists,
anesthetic agents, antiarrhythmics, antithrombotic agents,
chemotherapeutic agents, hypoglycemics, inotropic
medications, sedation agents, opiates, neuromuscular blocking
agents, and radiocontrast agents;
a valve disposed over the open end and a crimp ring with
a first upper end disposed over a portion of the valve and
having an opening to define an access port, and a second lower
end disposed over a portion of the flange-like rim;
a detachable cap disposed over the access port, the cap
terminating in a downtumed edge about the circumference of
the cap; and
a single tubular label disposed about the perimeter of the
vial, the tubular label extending only from a first lower edge
aligned with the closed end of the vial to a second upper edge
at the cap,
the label having a first lower section and a second upper
section separated by a single circumferential perforated
boundary aligned with the neck of the vial below the rim,
the first section of the label backed at least in part with an
adhesive, attached at least in part to the outer surface of the vial
and extending between the closed end of the vial and the
perforated boundary, and the second section extending at least
between the perforated boundary and the cap.
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Appeal2014-006053
Application 12/871, 101
REJECTIONS
1) Claim 1--4 and 7-11 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Novitch (US 3,811,591, iss. May, 21, 1974) in
view of Parrish (US 828,770, iss. Aug. 14, 1906) and Greene (US
2006/0073140 Al, pub. Apr. 6, 2006).
2) Claim 5 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Novitch in view of Parrish, Greene and Adler (US 7,311,205 B2,
iss. Dec. 25, 2007).
3) Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Novitch in view of Parrish, Greene, Adler and Papciak (US
5,284,263, iss. Feb. 8, 1994).
DISCUSSION
The Examiner found that Novitch discloses the elements of claim 1
other than the "wrapping to be a single label" and the recited pharmaceutical
products disposed in the receptacle. Final Act. 2, 4. The Examiner found
Parrish "teaches that it was well-known in the art to combine the functions
of a wrapper and the label as one." Id. at 3. One of the Examiner's
rationales for combining Parrish with Novitch is that "making two separate
parts integral ... would be merely a matter of obvious engineering choice."
Id. The Examiner further found that Greene discloses "chemotherapeutic
agents" and it would have been "obvious to put [] chemotherapeutic agents
into the Novitch container as a simple substitution of parts." Id. at 4.
Appellants contend that neither Novitch nor Parrish disclose "a
tubular label that is disposed about the perimeter of the vial and extends only
from a first lower edge aligned with the closed end of the vial to a second
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Appeal2014-006053
Application 12/871, 101
upper edge of the cap." Appeal Br. 5. Appellants contend Novitch's
"wrapping or envelope has an end wall 66 that is disposed below the bottom
of the allegedly corresponding vial." Id. at 6. The Examiner responds that
the lower edge ofNovitch's wrapper "is aligned vertically or placed
underneath the closed bottom end of the vial." Ans. 7.
Figures 7 and 8 ofNovitch disclose the lower edge of wrapper 66
extends below the closed end ofNovitch's vial both before and after the
wrapper is subjected to a heat shrinking process. Thus, the lower edge of
wrapper 66 and the closed end of the vial are not aligned either before or
after heat shrinking. See Novitch, Fig. 7 & 8; col. 4, 1. 63 - col. 5 1. 7. Thus,
the Examiner's finding that Novitch discloses a "tubular label extending
only from a first lower edge aligned with the closed end of the vial" is not
supported by a preponderance of the evidence. As the rejection is based on
an erroneous factual finding, the conclusion of obviousness cannot stand.
See In re Warner, 379 F.2d 1011, 1017 (CCPA 1967) (holding that "[t]he
legal conclusion of obviousness must be supported by facts. Where the legal
conclusion is not supported by facts it cannot stand."). Therefore, we do not
sustain the rejection, under 35 U.S.C. § 103(a), of claim 1 and claims 2--4
and 7-11 which depend thereon.
The Examiner relied on Novitch in combination with Parrish, Greene,
and Adler to reject dependent claim 5 and N ovitch in combination with
Parrish, Greene, and Papciak to reject dependent claim 6. The Examiner's
references to Adler and Papciak fail to cure the deficiencies in N ovitch noted
above for claim 1. Final Act. 5. For the same reasons stated above, we do
not sustain the rejection of claims 5 and 6.
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Appeal2014-006053
Application 12/871, 101
DECISION
The Examiner's decision rejecting claims 1-11 is REVERSED.
REVERSED
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