Ex Parte Atkinson

Patent Trial and Appeal Board

Feb 6, 2013

11570887 (P.T.A.B. Feb. 6, 2013)

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.
11/570,887 12/19/2006 Hartley Campbell Atkinson 1650 6269
58478 7590 02/06/2013
BIO INTELLECTUAL PROPERTY SERVICES (BIO IPS) LLC
8509 KERNON CT.
LORTON, VA 22079
EXAMINER
STONE, CHRISTOPHER R
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
02/06/2013 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 HARTLEY CAMPBELL ATKINSON
__________

Appeal 2011-007806
Application 11/570,887
Technology Center 1600
__________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
pharmaceutical composition. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses that an over-the-counter, “full therapeutic
dose of paracetamol (acetaminophen) is 1000 mg, [and] a full therapeutic
dose of ibuprofen is 400 mg to relieve pain. The total daily amount is also
limited to 4000 mg of paracetamol and 1200 mg of ibuprofen, per day in
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divided doses.” (Spec. 1:11-14.) Thus, the maximum daily amount of
paracetamol is the full therapeutic dose (1000 mg) four times per day, and
the maximum daily amount of ibuprofen is the full therapeutic dose (400
mg) three times per day (id. at 5:13-19). The Specification discloses a
composition that includes ibuprofen and paracetamol (id. at 3:3-5), and is
preferably “administered as two unit doses four times a day” (id. at 3:14).
Claims 27-32, 42-49 and 54-56 are on appeal. Claim 27 is
representative and reads as follows:
27. A combination pharmaceutical composition for the treatment of
pain including about 125 mg to about 150 mg ibuprofen and about 475 mg
to about 500 mg paracetamol.

Issue
The Examiner has rejected claims 27-29, 31, 32, 42-46, 49, and 54-56
under 35 U.S.C. § 103(a) as obvious in view of Tencza.
1
The Examiner has
also rejected claims 30, 47, and 48 as obvious in view of Tencza and Sims.
2

We will consider these rejections together since Appellant has waived any
argument based on Sims (Appeal Br. 18).
The Examiner finds that Tencza discloses “a pharmaceutical
composition comprising from 50mg to 400 mg of ibuprofen and from 150 to
500mg paracetamol administered … in the form of two tablets” (Answer 4).
The Examiner concludes that it would have been obvious to one of ordinary
skill in the art to prepare Tencza‟s composition “with 500mg of paracetamol
and 150mg of ibuprofen …, since the values fall within the ranges taught by

1
Tencza, CA 1,336,687, Aug. 23, 1989
2
Sims et al., US 5,260,337, Nov. 9, 1993
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Tencza et al to be effective in the preparation of a pharmaceutical
composition for pain relief” (id.).
Appellant contends that, although the amounts of ibuprofen and
paracetamol recited in claim 27 fall “within the broad ranges of the
disclosure of Tencza, there is nothing which would direct one of ordinary
skill in this art to the selection of such a very specific and limited range of
the many possible ratios of ingredients” disclosed by Tencza (Appeal Br.
13). Appellant also argues that he has provided evidence of unexpected
results that outweighs the evidence supporting the prima facie case of
obviousness (id. at 16-18).
The issues presented are: Does the evidence of record support the
Examiner‟s conclusion that Tencza would have made obvious a
pharmaceutical composition that includes 125-150 mg of ibuprofen and
475-500 mg of paracetamol? If so, has Appellant provided evidence of
unexpected results that outweighs the evidence supporting the prima facie
case of obviousness?
Findings of Fact
1. Tencza discloses “analgesic tablets that contain a combination of
ibuprofen, acetaminophen (APAP) and caffeine” (Tencza 3).
2. Tencza discloses that “[g]enerally … each tablet will contain from
about 50 mg. to about 400 mg. of ibuprofen. In the preferred case, the
effective analgesic dose will be delivered with two tablets each of which will
contain about 50 mg. to about 400 mg. of ibuprofen.” (Id. at 8.)
3. Tencza discloses that “generally each tablet will contain from
about 150 mg. to about 500 mg. of APAP…. In the preferred cases, two
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tablets are used to deliver[ ] an effective dose, each tablet will contain from
about 150 mg. to about 500 mg. of APAP” (id. at 9).
4. Tencza discloses that the tablets “may be used in the treatment of
those conditions for which over-the-counter analgesics are generally
recommended. These include the treatment of pain from neural and
muscular sources.” (Id. at 11.)
5. The Specification discloses that “[i]buprofen is taken without
prescription in doses of 200-400 mg every 6 hours up to 1200 mg/day for
analgesia” (Spec. 1:34-35).
6. Appellant has provided an affidavit of Hartley Campbell Atkinson
(filed February 10, 2010, Appeal Br. 43).
7. Dr. Atkinson declares:
I have always seen Maxigesic[
3
] as a counterintuitive product
… because the tablet is designed to be taken in duplicate, four
times each day, so that a patient gets 300 mg ibuprofen plus
1,000 mg paracetamol at each dose.… [O]ne would not
normally take 300 mg ibuprofen (ie 2 x 150 mg) each time
because that sort of dose is considered sub optimal. The norm
for ibuprofen is to take 400 mg at each dose.
(Atkinson Affidavit, ¶ 2).
8. Dr. Atkinson declares that
[a]nother reason that Maxigesic is counterintuitive is that for
optimal analgesic relief one would normally only take
ibuprofen three times each day (ie 3 x 400 mg). With
paracetamol … the normal dosage regimen for optimal relief is

3
“Maxigesic is a tablet containing 150 mg ibuprofen and 500 mg
paracetamol to be taken two tablets at each dose, four times each day.”
Affidavit of John Douglas Wilson (filed February 10, 2010, Appeal Br. 30),
at ¶ 23.
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to take it four times each day (ie 4 x 1,000 mg)…. The different
dosage regimens means that they would not be seen as logical
candidates for a combination medicine.
(Id. at ¶ 3.)
9. Appellant has provided an affidavit of John Douglas Wilson (filed
February 10, 2010, Appeal Br. 30).
10. Dr. Wilson declares that “[i]buprofen exhibits a shallow dose
response curve for pain relief showing a plateau at around 400mg. Doses of
400mg demonstrate superior efficacy above the lower doses of 200mg in
single dose studies.” (Id. at ¶ 13.)
11. Dr. Wilson declares that a “clinical trial was conducted … on a
fixed dose pain-relieving medicine called Maxigesic. Maxigesic is a tablet
containing 150 mg ibuprofen and 500 mg paracetamol to be taken two
tablets at each dose, four times each day.” (Id. at ¶ 23.)
12. Dr. Wilson declares that the results of the clinical trial “showed
that Maxigesic was vastly superior at all time points to either paracetamol
1000mg four times a day or ibuprofen 300mg four times a day” (id. at ¶ 27).
13. Dr. Wilson declares that “[t]he trial results were more than
surprising, rather they were exceptional, an unexpected degree of relief for
Maxigesic over its individual components. It must be remembered that the
individual drugs were given at their overall maximum recommended daily
doses … for the 24 hours.” (Id. at ¶ 28.)
14. Dr. Wilson declares that, in his view, “the trial results are clear
evidence of synergy between paracetamol and ibuprofen” (id. at ¶ 29).
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Analysis
Claim 27 is directed to a pharmaceutical composition for treating pain
that includes about 125-150 mg ibuprofen and about 475-500 mg
paracetamol (acetaminophen; Spec. 1:12).
Tencza discloses analgesic tablets that contain a combination of
ibuprofen, acetaminophen (paracetamol), and caffeine. Tencza discloses
that two tablets are used to deliver an effective dose, and that each tablet will
contain about 50-400 mg of ibuprofen and about 150-500 mg of
paracetamol. In view of the disclosure in Tencza, it would have been
obvious to one of ordinary skill in the art to formulate a pharmaceutical
composition comprising 125-150 mg of ibuprofen and 475-500 mg of
paracetamol because those amounts are within the ranges taught by Tencza
to provide effective doses for both ibuprofen and paracetamol. “[W]here
there is a range disclosed in the prior art, and the claimed invention falls
within that range, there is a presumption of obviousness.” Iron Grip Barbell
Co. Inc. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004).
Appellant argues that, although the claimed amounts fall “within the
broad ranges of the disclosure of Tencza, there is nothing which would
direct one of ordinary skill in this art to the selection of such a very specific
and limited range” (Appeal Br. 13). Appellant also argues that the three
Examples disclosed in Tencza have amounts of ibuprofen and paracetamol
that are not within the claimed ranges (id.).
This argument is not persuasive. “A prima facie case of obviousness
typically exists when the ranges of a claimed composition overlap the ranges
disclosed in the prior art.… Selecting a narrow range from within a
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somewhat broader range disclosed in a prior art reference is no less obvious
than identifying a range that simply overlaps a disclosed range.” In re
Peterson, 315 F.3d 1325, 1329-30 (Fed. Cir. 2003). Tencza discloses that its
formulation can include 50-400 mg of ibuprofen and 150-500 mg of
paracetamol, and therefore would have made obvious the selection of any
combination of amounts of ibuprofen and paracetamol within those ranges.
In addition, “in a section 103 inquiry, „the fact that a specific
[embodiment] is taught to be preferred is not controlling, since all
disclosures of the prior art, including unpreferred embodiments, must be
considered.‟” Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804,
807 (Fed. Cir. 1989). Thus, the lack of a working example in Tencza using
amounts of ibuprofen and paracetamol within the claimed range would not
have led a skilled worker to expect that other dosages within its disclosed
ranges would not be suitable.
Appellant argues that a skilled artisan would not have had a
reasonable expectation of success in formulating Tencza‟s composition with
the amount of ibuprofen recited in claim 27 because he “would have seen the
ibuprofen doses (150 mg x 2 = 300mg) as less than efficacious because the
medical industry has long held the view that for optimal relief 400 mg
ibuprofen should be taken at each dose” (Appeal Br. 14). Similarly,
Appellant argues that the industry taught away from the claimed amount of
ibuprofen because “if one reduced the ibuprofen content to say 300 mg per
dose (4 times each day – ie to be in step with 4 times per day paracetamol
dosing without, at the same time, exceeding the 1,200 mg daily maximum
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for ibuprofen) then one would be administering a less than effective amount
of ibuprofen at each dosing event” (id. at 15).
This argument is not persuasive. As recognized by the Examiner, a
skilled worker would recognize that the optimal amount of ibuprofen in a
dosage form will vary depending on a number of variables disclosed by
Tencza:
the number of tablets that are to be employed to deliver an
effect analgesic dosage (Tencza et al, p. 8, lines 15-18), the
particular condition to be treated (Tencza et al, p. 11, lines 6-
10), the particular patient population, e.g. children of a
particular average weight or adults of a particular average
weight, or a particular dosage regimen, e.g. a single dose for the
treatment of acute pain or a multitude of dosages for treatment
of more chronic pain.
(Answer 7.)
Consistent with this reasoning, Tencza states that an “effective
analgesic dose will be delivered with two tablets each of which will contain
about 50 mg. to about 400 mg. of ibuprofen” (FF 2, emphasis added),
supporting the Examiner‟s conclusion that the amount of ibuprofen in an
effective dose varies. We also note that Appellant‟s Specification states in
the “Background to the Invention” that “[i]buprofen is taken without
prescription in doses of 200-400 mg every 6 hours” (Spec. 1, 34-35),
providing further evidence that ibuprofen was recognized as effective at
different doses in different patients.
Appellant also argues that he has provided evidence of unexpected
results that overcomes the prima facie case of obviousness (Appeal Br. 16-
17). Appellant argues that the Wilson Declaration provides evidence that
“the amount of pain relief provided by 300 mg ibuprofen plus 1,000 mg
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paracetamol taken in combination every 6 hours … showed significantly
lower pain scores for the combination than for either one of the individual
active ingredients when taken at their recognised optimal dosages” (id. at
16). Appellant argues that the Wilson Declaration shows that the results
were synergistic (id.) and “establish[es] the unexpected nature of the
presently claimed invention” (id. at 17).
This argument is also unpersuasive. The burden of demonstrating
unexpected results rests on the party asserting them. In re Klosak, 455 F.2d
1077, 1080 (CCPA 1972). That burden has not been carried here because
Appellant has not provided comparative data to show that the claimed
dosage range provides unexpectedly superior results when compared to the
closest prior art. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991) (“[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.”).
Dr. Wilson discusses a clinical trial to assess the efficacy in pain
treatment of a combination of 1000 mg paracetamol and 300 mg ibuprofen,
as compared to either 1000 mg paracetamol alone or 300 mg ibuprofen
alone. However, Tencza discloses tablets containing 325 mg of paracetamol
and 100 mg of ibuprofen (Tencza 15). Thus, when compared to the two-
tablet-per-dose regimen of the Wilson Declaration, the closest prior art
dosage is a combination of 650 mg paracetamol and 200 mg ibuprofen (i.e.,
two of the tablets in Tencza‟s Example 1). Appellant has not provided
evidence that the combination recited in claim 27 provide unexpectedly
superior results when compared to the closest prior art.
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Conclusion of Law
The evidence of record supports the Examiner's conclusion that the
composition of claim 27 would have been obvious in view of Tencza.
Appellant has not provided evidence of unexpected results that outweighs
the evidence supporting the prima facie case of obviousness.
Thus, we affirm the rejection of claim 27 as being obvious in view of
Tencza. Claims 28, 29, 31, 32, 42-46, 49, and 54-56 have not been argued
separately and therefore fall with claim 27. 37 C.F.R. § 41.37(c)(1)(vii).
We also affirm the rejection of claims 30, 47, and 48 as being obvious in
view of Tencza and Sims since Appellant has waived any arguments based
on Sims.
SUMMARY
We affirm the rejection of claims 27-32, 42-49, and 54-56 under 35
U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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