Ex Parte Mitchell et al

Patent Trial and Appeal Board

Sep 29, 2016

13705215 (P.T.A.B. Sep. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
131705,215 12/05/2012
27752 7590 10/03/2016
THE PROCTER & GAMBLE COMPANY
Global IP Services
Central Building, C9
One Procter and Gamble Plaza
CINCINNATI, OH 45202
FIRST NAMED INVENTOR
Will Howard Mitchell
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.
9347C 3430
EXAMINER
MATOS NEGRON, TAINADELMAR
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
10/03/2016 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):
centraldocket.im @pg.com
pair_pg@firsttofile.com
mayer.jk@pg.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILL HOW ARD MITCHELL,
LINDA CAROL JONES, JOHN STEPHEN EADICICCO, and
BETH WAGGONER RUSSELL 1
Appeal2015-006108
Application 13/705,215
Technology Center 1600
Before JOHN G. NEW, JOHN E. SCHNEIDER, and RYAN H. FLAX,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is The Procter & Gamble
Company. App. Br. 1.
Appeal2015-006108
Application 13/705,215
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1, 2, 4--10, and 21 as unpatentable
under 35 U.S.C. §103(a) as being obvious over the combination of Chen (US
2002/0045184 Al, April 18, 2002) ("Chen"), Newman (WO 03/016175 Al,
February 27, 2003) ("Newman"), and Center for Drug Evaluation and
Research, Food and Drug Administration, Minutes of the Joint Meeting of
the Nonprescription Drugs Advisory Committee with the Gastrointestinal
Drugs Advisory Committee, June 21, 2002 (the "Committee Minutes").
We have jurisdiction under 35 U.S.C. § 6(b)
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to kits useful for facilitating
compliance \'l1ith a treatment regimen. Spec. 1: 10-13. In one embodiment,
the kits are useful for compliance with a defined method of treatment which
utilizes a composition comprising a gastric acid secretion inhibitor. Id. In
an alternative or additional embodiment, the kits comprise an outer container
and at least two inner containers, wherein each of the inner containers
comprise, independently, a plurality of unit doses of a composition
comprising a therapeutically effective amount of a gastric acid secretion
inhibitor. Spec. Abstract and 4--5.
REPRESENTATIVE CLAIM
Appellants argue the claims together. App. Br. 3. Claim 1 is
representative of the claims on appeal, and recites:
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Application 13/705,215
1. A method of facilitating compliance with an over-the-counter
heartburn treatment regimen comprising:
a. providing an outer container enclosing 2 inner containers
wherein each inner container contains a blister pack and the
blister pack contains 14 unit doses of a composition
comprising a therapeutically effective amount of omeprazole
or an omeprazole salt and wherein the outer container and
each inner container further comprise a surface and wherein
instructions for compliance with the heartburn treatment
regimen are printed on the surface;
b. administering a treatment wherein one unit dose of the
composition every day for 14 days; and
c. repeating the treatment after a period of about 75 days to
about 135 days.
App. Br. 8.
ISSUES AND ANALYSIS
We agree with, and adopt, the Examiner's findings and conclusion
that the appealed claim is prima facie obvious over the cited prior art
references. We address the arguments raised by Appellants below.
Issue
Appellants argue the Examiner erred in finding the claims obvious
over the combined cited prior art. App. Br. 5.
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Appeal2015-006108
Application 13/705,215
Analysis
Appellants argue Chen neither teaches nor suggests an outer container
enclosing two or three inner containers in which each inner container
contains a blister pack. App. Br. 5. Appellants assert that, at most, Chen
discloses a single container that can enclose a plurality of blister packages.
Id.
Appellants also assert that the teachings of Newman fail to cure the
alleged deficiencies of Chen. App. Br. 5. According to Appellants,
Newman discloses a single use package for holding a contact lens. Id.
(citing Newman, Abstr.). Appellants assert that Newman teaches envelopes
holding retort packaging saves space in comparison to prior packaging
methods, including blister packs. Id. (citing Newman 18).
Furthermore, Appellants contend, Newman teaches the undesirability
of using blister packs, teaching that conventional blister packages include
aluminum foil, which is tightly stretched over the blister cavities to seal the
blister pack. Id. at 5-6 (citing Newman 19). Appellants assert that Newman
teaches that, due to the foil' s tightness, it can be "more easily punctured"
when compared to retort packaging, which is flexible and can deflect
potential punctures. Id. at 6. Appellants also argue that Newman teaches
that retort packaging also provides significant space saving as it "is
significantly smaller and slimmer" than blister cards. Id. (citing Newman
20).
Finally Appellants argue the Examiner's proposed modification of
Chen would render it unsatisfactory for its intended purpose. App. Br. 6.
According to Appellants, Chen aims to provide a single packaging system
that provides convenient, easy distribution and administration of the
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Application 13/705,215
combination therapies. App. Br. 6 (citing Chen if 5). Appellants contend the
claimed packaging would frustrate the purpose of Chen because, instead of a
convenient, single packaging system, the presently claimed invention
requires a user to sequentially open an outer package, then open an inner
package, and then open a blister pack before the medication can be
consumed. Id. Appellants therefore argue that there would have been no
suggestion or motivation to make the proposed modification. Id.
The Examiner responds that Chen teaches a packaging system
including "a blister pack rack having a plurality of shelves (i.e., containers)
suitable for holding, storing, shipping and dispensing a plurality of blister
cards." Ans. 12 (citing Chen Fig. 53; if60). The Examiner therefore finds
Chen "suggests a system for holding 2 or 3 blister cards separately from one
another (i.e., in the separate shelves/compartments)," in which "the separate
compartments are included in an outer container (i.e., the outer edges of the
box)." Id.
The Examiner relies upon the teachings of Newman solely to
demonstrate the fact that a plurality of boxes containing blister cards within
an outer container is not a novel invention. Ans. 14. The Examiner finds
Newman teaches a carton containing a large number of envelopes holding
packing strips. Id. (citing Newman 14; Fig. 10). The Examiner finds that
the packing strips of Newman may be slimmer than a traditional blister card
is irrelevant because Chen is explicitly relied upon for teaching blister cards
containing omeprazole. Id. at 14--15.
With respect to Appellants' argument that combining the teachings of
Chen and Newman would render the invention of Chen unsuitable for its
intended purpose, the Examiner finds that Chen's teaching of a system to
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Application 13/705,215
increase convenience and compliance refers to administration of the
combination of the drugs provided in the blister packs and the fact that the
packaging allows for easy distribution of both drugs at once. Ans. 15. The
Examiner concludes that the combination of Chen and the Committee
Minutes would have, to a person of ordinary skill, rendered obvious
treatment of heartburn with omeprazole with a 14 day course to be repeated
two to three times a year. Id.
We are not persuaded by Appellants' arguments. Chen teaches: "the
invention also provides a blister pack rack 17 having a plurality of shelves
18, suitable for holding, storing, shipping, or dispensing a plurality[] of
blister cards or drug packaging systems of the invention." Chen i-f 60; see
also Fig. 53. We agree with the Examiner that the segregation of the blister
packs into separate compartments within an outer box is suggestive of
containing the blister packs of omeprazole tablets in separate internal boxes.
Furthermore, we agree with the Examiner that Newman teaches
packaging multiple multi-unit blister cards in inner containers, with
multiples of such boxes in tum packaged in an outer box. See Ans. 13.
Figure 10 ofNewman depicts:
[a] carton 40 containing a large number oflike envelopes 41 [i.e.,
inner containers] holding retort package strips 42 according to a
preferred embodiment. It can be seen from this arrangement that
a larger number of lenses may be stored per unit space compared
to prior art packaging. Up to and depending upon the tightness
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Appeal2015-006108
Application 13/705,215
of the packaging more than 10 lenses may be stored in a space
which would previously have been taken by two lens packages.
Newman 18. We agree with the Examiner that the combination of Chen and
Newman thus teaches "an outer container enclosing 2 inner containers
wherein each inner container contains a blister pack," as recited in claim 1.
However, we are not persuaded that the combination of Chen and
Newman would render the invention of Chen unsuitable for its intended
purpose, as contended by Appellants. Chen teaches that the blister packs
may be segregated into different "racks" or dividers affixed to the internal
surface of the outer container. The substitution of an individual container
holding a blister in place of a segregating, fixed divider would still serve the
purpose of Chen of segregating the blister packs from each other for
individual use. See Chen i-f 60.
Consequently, we agree with the Examiner's conclusion that claims 1,
2, 4--10, and 21 are obvious over the combined cited prior art is supported by
the preponderance of the evidence presented and, therefore, we affirm the
rejection of the claims.
DECISION
The Examiner's rejection of claims 1, 2, 4--10, and 21 as unpatentable
under 35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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