Ex Parte Pridgen

Patent Trial and Appeal Board

Mar 15, 2017

14459905 (P.T.A.B. Mar. 15, 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.
14/459,905 08/14/2014 William L. Pridgen 16210-000004-US-COA 6793
28997 7590 03/17/2017
HARNESS, DICKEY, & PIERCE, P.L.C
7700 Bonhomme, Suite 400
ST. LOUIS, MO 63105
EXAMINER
PIHONAK, SARAH
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/17/2017 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):
stldocket@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM L. PRIDGEN1
Appeal 2016-007679
Application 14/459,905
Technology Center 1600
Before DONALD E. ADAMS, ROBERT A. POLLOCK, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s
Final Rejection of claims 46—69, which constitute all the claims pending in
this application. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Appellant’s invention relates “to pharmaceutical compositions
comprising a combination of a therapeutically-effective amount of the
antiviral compound famciclovir and a therapeutically-effective amount of
the COX-2 inhibitor celecoxib. The invention is also related to methods of
1 Appellant identifies the real party-in-interest as Innovative Med Concepts,
Inc. App. Br. 3.
Appeal 2016-007679
Application 14/459,905
treating functional somatic syndromes by administering a therapeutically-
effective combination of famciclovir and celecoxib.” Spec. Abstract.
Claim 49, the sole independent claim before us, recites:
49. A kit presentation for treating one or more functional somatic
syndrome conditions, comprising:
a therapeutically-effective amount of famciclovir,
a therapeutically-effective amount of celecoxib, and
printed directions for administration of famciclovir and
celecoxib to obtain a disease treatment therapeutic outcome,
wherein each of the first and second unit dosage forms is
enclosed in one or more containers,
wherein famciclovir and celecoxib are each present in a dosage
amount therapeutically effective to treat the one or more
functional somatic syndrome conditions selected from the group
consisting of fibromyalgia, chronic fatigue syndrome, and
irritable bowel syndrome, and
wherein the printed directions comprise a disease-treatment
regimen instruction sheet for treatment of the one or more
functional somatic syndrome conditions selected from the group
consisting of fibromyalgia, chronic fatigue syndrome, and
irritable bowel syndrome.
In general, dependent claims 50-53 relate to the somatic syndrome
conditions set forth in independent claim 46; claims 54—58, 60, and 62—69
relate to dosing amounts and schedules; and claims 59, 61, 64, and 67 relate
to the contents of the printed directions.
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STATEMENT OF THE REJECTION
Claims 46—69 stand rejected under 35 U.S.C. § 103(a) as obvious over
the combination of Maziasz2 and Remington.3 Appellant argues claims 46—
49 as a group.
FACTUAL FINDINGS
We have reviewed Appellant’s contentions that the Examiner erred in
rejecting claims 46—69 as unpatentable over the cited art. (App. Br. 4—14;
Reply 1—4.) We disagree with Appellant’s contentions and adopt findings of
fact and reasoning regarding the scope and content of the prior art set forth
in the Examiner’s Answer and the Final Rejection dated July 16, 2015. We
highlight and address the following for emphasis:
Findings of Fact
FF1. Maziasz “provides compositions and methods for the treatment of
herpes virus infections. In one aspect, the invention provides a
combination therapy for treating a herpes virus infection comprising the
administration to a subject of an anti-herpes virus agent in combination
with a cyclooxygenase-2 [COX-2] selective inhibitor.” Maziasz,
Abstract. Maziasz discloses that the COX-2 inhibitor and the anti-herpes
agent may be administered substantially simultaneously or sequentially.
Id. 1131.
FF2. Claim 13 of Maziasz provides that “the [COX-2] inhibitor is selected
from the group consisting of celecoxib, deracoxib, valdecoxib, rofecoxib,
lumiracoxib, etoricoxib, and parecoxib; and the anti-herpes virus agent is
2 Maziasz, WO 2004/056349 A2, published July 8, 2004.
3 Remington: The Science and Practice of Pharmacy 21st ed., pp. 1023,
1034—36, and 1823-39 (2005) (“Remington”).
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selected from the group consisting of acyclovir, famciclovir, and
valaciclovir.” See also id., 1 80 (“In still another embodiment, the
cyclooxygenase-2 selective inhibitor is selected from the group
consisting of celecoxib, rofecoxib and etoricoxib.”). Paragraph 134 of
the reference expressly discloses the combination of celoxoxib and
famciclovir.
FF3. Maziasz further discloses that “when the cyclooxygenase-2 selective
inhibitor comprises celecoxib, it is typical that the amount used is within
a range of from about 1 to about 20 mg/daykg, even more typically,
from about 1.4 to about 8.6 mg/daykg, and yet more typically, from
about 2 to about 3 mg/daykg.” Id. 1103. “[W]hen the anti-herpes virus
agent is famciclovir, it is typical that the amount used is approximately
500 to about 1500 milligrams per day for seven to ten days and even
more commonly, about 750 milligrams per day.” Id. 1127.
FF4. Remington teaches that “[t]he federal government has required that
patient product information be provided with the dispensing of certain
drugs to ensure that the patient is apprised of proper use of the
medication, its benefits and risks, and the signs of adverse reaction.”
Remington, 1829.
Analysis
The Examiner finds that Maziasz teaches a combination of celecoxib
and famciclovir in separate formulations, but does not explicitly disclose a
kit with instructions for administering these compounds for treating a
chronic disease selected from fibromyalgia, chronic fatigue syndrome, and
irritable bowel syndrome. Ans. 5. The Examiner nevertheless finds that
Maziasz discloses celecoxib “as a COX-2 inhibitor within a small, defined
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Application 14/459,905
group of COX-2 inhibitors, and famciclovir ... as an antiviral agent for
selection within a small, defined group of antiviral agents,” and, thus, “it
would have been prima facie obvious to have selected the combination of
celecoxib and famciclovir in view of Maziasz.” Id. at 16. The Examiner
further finds that, in view of Remington, “it would have been prima facie
obvious to have dispensed the dosage forms of famciclovir and celecoxib in
containers with written instructions for use and administration,” as required
by claim 46. Id. at 15. Accordingly, the Examiner finds that
the only difference between the instant claims and the
combination comprising famciclovir and celecoxib as taught by
the combined teachings of Maziasz and Remington is with
regards to the specific instructions for intended use of the product
as recited in instant claim 49. However, when a product is taught
by the prior art the incorporation of instructions, such as printed
matter, which is not functionally related to the product itself will
not distinguish the product from the prior art.
Id. at 7—8 (citing In reNgai, 367 F.3d 1336, 1339 (Fed. Cir. 2004).
Appellant contends that the Examiner errs in failing to treat the
preamble limitation “treating one or more functional somatic syndrome
conditions” as a positive limitation, as opposed to a statement of intended
use. App. Br. 4—8. To the extent the preamble may be read as other than a
statement of intended use, we agree with the Examiner that the prior art
“meets the structural limitations of the kit recited in claim 49, and therefore .
. . would have been expected to provide the same properties and perform the
same function as the claimed kit.” Ans. 15. “[SJince the prior art teaches a
product having the same structural limitations as the instantly claimed kit,
claimed properties or functions are presumed to be inherent.” Ans. 15; see
In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990) (“The discovery of a new
property or use of a previously known composition, even when that property
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Application 14/459,905
and use are unobvious from prior art, cannot impart patentability to claims to
the known composition.”); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990).
Appellant also argues that the Examiner impermissibly singles out
celecoxib and famciclovir from a “laundry list” of possible COX-2
inhibitors/anti-viral combinations disclosed in Maziasz. See Reply 2-4.
We do not find Appellant’s argument persuasive. First, Maziasz claim 13
sets forth a small genus of seven possible COX-2 inhibitors (including
celecoxib) and a smaller genus of three possible anti-viral agents (including
famciclovir). See FF2. Moreover, Maziasz expressly discloses the claimed
combination. See id.
Second, despite Appellant’s argument that the combination of
celecoxib and famciclovir provides unexpected results (discussed below), we
find no evidence of record suggesting that the combinations set forth in
Maziasz do not all have equivalent properties. See Merck & Co. Inc. v.
Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (where the
prior art patent disclosed a genus of 1200 effective combinations of
compounds, including claimed combination, “[d]isclos[ure of] a multitude of
effective combinations does not render any particular formulation less
obvious”).
With respect to Appellant’s evidence of unexpected results, we agree
with the Examiner that “Applicant has not shown how the specific
combination of celecoxib and famciclovir possesses advantageous features
that are not present for other combinations of COX-2 inhibitors and antiviral
agents taught by Maziasz.” Ans. 18. Appellant first contends that the
claimed combination “achieved a significant decrease in pain with patients
on treatment vs. placebo at 16 weeks.” App. Br. 12—13 (Relying on the
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Declaration under 37 C.F.R. § 1.132 of William L. Pridgen, M.D., dated
June 13, 2014 (“Pridgen Declaration”). This comparison, however, fails to
compare the claimed combination of celecoxib and famciclovir with any
other combination of COX-2 inhibitors and antiviral agents taught by
Maziasz.
Appellant also argues that whereas “the CELEBREX product insert
shows that celecoxib users incurred 47% increase in diarrhea and 46%
increase in abdominal pain relative to the incidence of these disorders among
the placebo group,” in another study (PRID-201 Phase 2a clinical trial), the
rate of gastrointestinal events in patients taking the combination of celecoxib
and famciclovir was 29% as compared to 42.5% for those assigned to
placebo, and the rate of discontinuation due to adverse events in the latter
two groups was 5.8% vs 16.2%. Id. at 13 ; see Pridgen Declaration || 8—10.
As an initial matter, it is unclear whether the historical data from the
CELEBREX product insert is properly compared to the PRID-201 data
insofar as Appellant does not establish that the patient populations, dose,
dosing schedule, and ascertainment criteria in the two studies are
comparable, or that rates of diarrhea and abdominal pain in the historical
data are equivalent to the “gastrointestinal events” in the PRID-201 trial.
More to the point, Appellant’s data, at best, compares the side effect profile
of (1) placebo, (2) celecoxib, and (3) the combination of celecoxib and
famciclovir. As above, Appellant fails to compare the claimed combination
of celecoxib and famciclovir with any other combination of COX-2
inhibitors and antiviral agents taught by Maziasz.
We, therefore, accord little weight to Appellant’s evidence of
unexpected results.
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CONCLUSION
For the reasons set forth above, as set forth in the Examiner’s Answer
and Final Rejection, and in view of the evidence of record, we agree with the
Examiner that claims 46—69 are unpatentable in view of the cited art.
SUMMARY
We affirm the rejection of claims 46—69 under § 35 U.S.C. 103(a) as
obvious in light of Maziasz and Remington.
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)(l)(iv).
AFFIRMED
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