Ex Parte Rice

Board of Patent Appeals and Interferences

Sep 14, 2010

11367500 (B.P.A.I. Sep. 14, 2010)

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.
11/367,500 03/02/2006 Bronwyn C. Rice RIE 60Z 7040
7590 09/14/2010
Ingrid McTaggart
3021 S. E. 56th Avenue
Portland, OR 97206-2003
EXAMINER
CLAYTOR, DEIRDRE RENEE
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
09/14/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BRONWYN C. RICE
__________

Appeal 2010-004944
Application 11/367,500
Technology Center 1600
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to chewable
pain relief compositions. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We vacate and enter a new
grounds of rejection.

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 C.F.R. § 1.304, or for filing a request
for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from
the “MAIL DATE” (paper delivery mode) or the
“NOTIFICATION DATE” (electronic delivery mode) shown on
the PTOL-90A cover letter attached to this decision.
Appeal 2010-004944
Application 11/367,500

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Statement of the Case
The Claims
Claims 1-14 are on appeal. Claim 1 is representative of the
argued claims. Claim 1 reads as follows:
1. A chewable pain relief composition,
comprising:
acetaminophen, present in a therapeutically-
effective amount;
ibuprofen, present in a therapeutically-
effective amount; and
a chewable binding agent, present in an
amount effective to facilitate breakdown of said
composition during chewing thereof.

The issue
The Examiner rejected claims 1-14 under 35 U.S.C. § 103(a) as
obvious over Geyer2 (Ans. 4-5). The Examiner also rejected claims 1-14
under 35 U.S.C. § 103(a) as obvious over Mehta3 (Ans. 5-7).
We vacate the Examiner’s rejections and enter the following new
grounds of rejection.

New Grounds of Rejection
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new grounds of rejection.
Claims 1-14 are rejected under 35 U.S.C. § 103(a) as obvious over
Menhinick4, Pickering5, Geyer, and Mehta.

2 Geyer et al., US 5,380,535, issued Jan. 10, 1995.
3 Mehta, US 4,800,087, issued Jan. 24, 1989.
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Findings of Fact
1. Menhinick teaches that the “purpose of this double-blind,
prospective pain study was to compare ibuprofen, used commonly to control
postoperative endodontic pain, against a combination of ibuprofen and
acetaminophen or a placebo” (Menhinick 532, col. 2). Menhinick teaches
that it “is hypothesized that the drug combination will be more effective at
controlling postoperative pain than the placebo or ibuprofen alone”
(Menhinick 532, col. 2).
2. Menhinick teaches that a “pharmacist . . . prepared the
following drug groups: 600 mg ibuprofen . . . 600 mg of ibuprofen plus 1000
mg of acetaminophen . . . or the lactose placebo” (Menhinick 533, col. 1-2).
3. Menhinick teaches that “Breivik et al. (1999) using a third
molar extraction model, provides the only other well-controlled dental study
evaluating this combination of drugs. The combination of acetaminophen
and an NSAID provided superior and prolonged analgesia with fewer side
effects when compared with the combination of acetaminophen and
codeine” (Menhinick 537, col. 1).

4 Menhinick et al., The efficacy of pain control following
nonsurgical root canal treatment using ibuprofen or a combination
of ibuprofen and acetaminophen in a randomized, double-blind,
placebo-controlled study, 37 INT’L ENDODONTIC J. 531-541 (2004).
5 Pickering et al., Double-blind, placebo-controlled analgesic study
of ibuprofen or rofecoxib in combination with paracetamol for
tonsillectomy in children, 88(1) BRITISH J. ANAESTHESIA 72-7
(2002).
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4. Menhinick teaches that the “outcome of this study suggests that
the combination of ibuprofen and acetaminophen was more effective at
reducing postoperative pain than ibuprofen alone” (Menhinick 539, col. 2).
5. Paracetamol is a synonym for acetaminophen.
6. Pickering teaches that the “aim of our randomized, double-
blinded, placebo-controlled pragmatic clinical study was to examine whether
combining a NSAID (ibuprofen 5 mg kg-1) or COX-2 antagonist (rofecoxib
0.625 mg kg-1) with paracetamol (20 mg kg-1) before paediatric
tonsillectomy would confer analgesic benefits without increasing
intraoperative blood loss” (Pickering 73, col. 1).
7. Pickering teaches that “children were premedicated 1 h before
surgery with paracetamol syrup 20 mg kg-1 and either placebo, ibuprofen 5
mg kg-1 or rofecoxib 0.625 mg kg-1” (Pickering 73, col. 2).
8. Pickering teaches that a “standardized postoperative analgesic
regimen was prescribed of regular paracetamol (15 mg kg-1, 4 hourly) with
oral ibuprofen (5 mg kg-1) or oral codeine (1 mg kg-1) to be administered at
the child’s request by the ward nursing staff” (Pickering 73, col. 2).
9. Pickering teaches that “[i]buprofen in combination with
paracetamol as premedication reduced the need for early supplementary
analgesia by almost 50% after tonsillectomy. The clinical importance of this
finding is indicated by the higher pain scores at the time of supplementary
analgesia in the children requiring early rescue” (Pickering 74, col. 2).
10. Pickering teaches that “[w]e have shown analgesic benefit
without increased risk of complications by combining ibuprofen with
paracetamol for premedication” (Pickering 76, col. 1).
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11. Geyer teaches “for certain classes of ill persons . . . swallowing
of a tablet or capsule containing these unpalatable compounds is difficult or
impossible; this is particularly so in the elderly or in young children” (Geyer,
col. 1, ll. 61-65).
12. Geyer teaches that “[f]ormulations for oral delivery of various
pharmaceutically-active compounds, particularly unpalatable ones such as
aspirin, ibuprofen, cimetidine, acetaminophen, erythromycin, or the like, are,
well known in the art” (Geyer, col. 1, ll. 23-27).
13. Geyer teaches that the “chewable composition preferably
contains a rapid dispersal agent that is a cellulose derivative, more
preferably the dispersal agent is croscarmellose sodium. The chewable
composition is formulated to disperse and disintegrate rapidly in the mouth
while masking the taste of the drug throughout the mastication process”
(Geyer, col. 2, ll. 39-45).
14. Geyer teaches that a “lubricant, such as magnesium stearate,
talc, calcium stearate, stearic acid . . . is preferably admixed with the drug
composition to enhance processability of the powder in the tableting
process” (Geyer, col. 7, ll. 22-26).
15. Geyer teaches that the composition may include coloring agents
(see Geyer, col. 5, l. 68).
16. Geyer teaches that “optional additives which may be included
in the final product are . . . sweeteners . . . such as sorbitol or dextrose, or
synthetic sweeteners such as aspartame” (Geyer, col. 6, ll. 29-33).
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17. Geyer teaches that the “amount of the rapid dispersal agent
present in the composition can range . . . from about 2 to about 20 percent”
(Geyer, col. 6, ll. 44-46).
18. Mehta teaches a “coated acetaminophen core that masks the
bitter and unpleasant taste of acetaminophen is provided. A method of
producing chewable tablets incorporating the coated acetaminophen is also
described. The coating composition and the method of producing chewable
tablets may be modified to provide taste-masking properties to a large
number of unpleasant tasting drugs” (Mehta, col. 1, ll. 10-17).
19. Mehta teaches that the “taste-masking microcapsules are
especially useful for bitter or unpleasant tasting drugs . . . for example,
acetaminophenibuprofen” (Mehta, col. 7, ll. 40-45).
20. Mehta claims a composition “wherein said pharmaceutically
active agent is selected from the group consisting of . . . acetaminophen,
ibuprofen” (Mehta, col. 12, ll. 36-39; claim 11).
21. Mehta teaches “a spray binder solution or suspension
comprised of, for example, polyvinyl pyrrolidone, starch,
hydroxypropylmethyl cellulose or microcrystalline cellulose (Avicel, from
FMC) among other excipients” (Mehta, col. 8, ll. 19-22).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
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The Supreme Court has emphasized that “the [obviousness] analysis need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” KSR Int'l v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
Claims 1 and 10
Menhinick teaches that “the combination of ibuprofen and
acetaminophen was more effective at reducing postoperative pain than
ibuprofen alone” (Menhinick 539, col. 2; FF 4). Menhinick also notes that
other prior art showed that the “combination of acetaminophen and an
NSAID provided superior and prolonged analgesia with fewer side effects
when compared with the combination of acetaminophen and codeine”
(Menhinick 537, col. 1; FF 3).
Pickering also teaches “analgesic benefit without increased risk of
complications by combining ibuprofen with paracetamol [i.e.,
acetaminophen] for premedication” (Pickering 76, col. 1; FF 5, 10).
While Menhinick and Pickering both teach that the combination of
ibuprofen and acetaminophen provides superior pain relief over the use of
either drug alone, neither Menhinick nor Pickering teach incorporation of
these drugs into chewable compositions.
Geyer teaches “[f]ormulations for oral delivery of various
pharmaceutically-active compounds, particularly unpalatable ones such as
aspirin, ibuprofen, cimetidine, acetaminophen, erythromycin, or the like, are,
well known in the art” (Geyer, col. 1, ll. 23-27; FF 12). Mehta teaches that a
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“coated acetaminophen core that masks the bitter and unpleasant taste of
acetaminophen is provided. A method of producing chewable tablets
incorporating the coated acetaminophen is also described. The coating
composition and the method of producing chewable tablets may be modified
to provide taste-masking properties to a large number of unpleasant tasting
drugs” (Mehta, col. 1, ll. 10-17; FF 18).
We find that it would have been obvious to one of ordinary skill in the
art at the time the invention was made to modify the
ibuprofen/acetaminophen combination tablets taught by Pickering and
Menhinick as superior to the drugs alone (FF 1-4, 6-10) to form chewable
compositions as taught by Geyer and Mehta since Geyer and Mehta teach
that unpalatable drugs such as acetaminophen and ibuprofen may be
formulated in a chewable composition “to disperse and disintegrate rapidly
in the mouth while masking the taste of the drug throughout the mastication
process” (Geyer, col. 2, ll. 39-45; FF 13).
We conclude that there are multiple reasons to modify the
ibuprofen/acetaminophen combination tablets taught by Pickering and
Menhinick to be chewable, including masking bitter tastes (FF 13, 19) as
well as permitting patients with difficulty swallowing tablets such as
children or elderly (see Geyer, col. 1, ll. 61-65; FF 11) to obtain the
improved pain relief provided by the combination of ibuprofen and
acetaminophen (FF 1-4, 6-10). Such a combination is merely a “predictable
use of prior art elements according to their established functions.” KSR, 550
U.S. at 417.

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Claims 2-9, 11-14
With regard to claims 2 and 11, Geyer teaches that the “chewable
composition preferably contains a rapid dispersal agent that is a cellulose
derivative, more preferably the dispersal agent is croscarmellose sodium.
The chewable composition is formulated to disperse and disintegrate rapidly
in the mouth while masking the taste of the drug throughout the mastication
process” (Geyer, col. 2, ll. 39-45; FF 13).
With regard to claim 3, Geyer teaches that a “lubricant, such as
magnesium stearate, talc, calcium stearate, stearic acid . . . is preferably
admixed with the drug composition to enhance processability of the powder
in the tableting process” (Geyer, col. 7, ll. 22-26; FF 14).
With regard to claim 4, Geyer teaches that the composition may
include coloring agents (see Geyer, col. 5, l. 68; FF 15).
With regard to claims 5 and 6, Geyer teaches that “optional additives
which may be included in the final product are . . . sweeteners . . . such as
sorbitol or dextrose, or synthetic sweeteners such as aspartame” (Geyer, col.
6, ll. 29-33; FF 16).
With regard to claims 7 and 12, Geyer teaches that the “amount of the
rapid dispersal agent present in the composition can range . . . from about 2
to about 20 percent” (Geyer, col. 6, ll. 44-46; FF 17).
With regard to claims 8, 9, 13, and 14, Menhinick teaches tablets with
more than 75 mg of ibuprofen and more than 150 mg of acetaminophen,
specifically Menhinick teaches that a “pharmacist . . . prepared the following
drug groups: 600 mg ibuprofen . . . 600 mg of ibuprofen plus 1000 mg of
acetaminophen . . . or the lactose placebo” (Menhinick 533, col. 1-2; FF 2).
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SUMMARY
In summary, we vacate the rejection of claims 1-14 under 35 U.S.C. §
103(a) as obvious over Geyer. We vacate the rejection of claims 1-14 under
35 U.S.C. § 103(a) as obvious over Mehta.
This decision also contains new grounds of rejection pursuant to 37
C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 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.”
Claims 1-14 are subject to the new grounds of rejection as discussed
above.
37 C.F.R. § 41.50(b) also provides that the Appellants, 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
proceeding 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. . . .

Appeal 2010-004944
Application 11/367,500

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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)(2006).

VACATED, § 41.50(b)

alw

INGRID MCTAGGART
3021 S. E. 56TH AVENUE
PORTLAND, OR 97206-2003