Ex Parte Pridgen

Patent Trials and Appeals Board

Jun 17, 2019

14543403 - (D) (P.T.A.B. Jun. 17, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/543,403 11/17/2014 William L. Pridgen
28997 7590 06/19/2019
Harness Dickey (St. Louis)
7700 Bonhomme, Suite 400
ST. LOUIS, MO 63105
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.
16210-000011-US-DVA 6631
EXAMINER
STRONG, TORI
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
06/19/2019 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
bkamer@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WILLIAM L. PRIDGEN
Appeal2018-004271
Application 14/543,403 1
Technology Center 1600
Before RYAN H. FLAX, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating a subject susceptible to or afflicted with at least one functional
somatic syndrome condition, such as fibromyalgia, which have been rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b ).
We reverse.
STATEMENT OF THE CASE
Fibromyalgia is a systemic disorder that often presents with irritable
bowel syndrome and chronic fatigue syndrome. (Spec. ,r 3.) According to
Appellants' Specification "[t]he focus of drug therapy for [fibromyalgia] is
1 Appellant is Innovative Med Concepts, Inc., which identifies itself as the
real party in interest. (Appeal Br. 3.)
Appeal2018-004271
Application 14/543,403
primarily symptomatic." (Id. ,r 6.) Treatments include anti-epileptic
medicines such as pregabalin and gabapentin, the serotonin and
norepinephrine reuptake inhibitors duloxetine hydrochloride and
milnacipran hydrochloride, and tricyclic antidepressants, selective serotonin
reuptake inhibitors, nonsteroidal anti-inflammatory analgesics and muscle
relaxers. (Id. ff 6-7.) However, according to Appellants' Specification,
"there is a need for new, more effective treatments." (Id. ,r 8.)
Claims 11-13 and 17-19 are on appeal. Claim 11 is representative
and reads as follows:
11. A method to treat a subject susceptible to or afflicted with
one or more functional somatic syndrome conditions
comprising: fibromyalgia, chronic fatigue syndrome, irritable
bowel syndrome, chronic pain, chronic headache, chronic neck
pain, chronic back pain, chronic depression, chronic clinical
anxiety disorder, post-traumatic stress disorder (PTSD), brain
fog, cognitive dysfunction and chronic interstitial cystitis, the
method comprising administering to the subject a
therapeutically effective combination of aciclovir and
celecoxib, wherein the amount of aciclovir is administered in a
total daily dose range from about 400 mg to about 1600 mg,
and wherein the amount of celecoxib is administered in a total
daily dose range from about 200 mg to about 800 mg, and
wherein the combination administered produces no substantial
adverse event.
(Appeal Br. 11.)
2
Appeal2018-004271
Application 14/543,403
The following ground of rejection by the Examiner is before us on
review:
Claims 11-13 and 17-19 under 35 U.S.C. § 103 as unpatentable over
Horrobin, 2 Wolfe, 3 and Celebrex. 4
DISCUSSION
The Examiner finds that Horrobin teaches aciclovir ( also known as
acyclovir) for treating fibromyalgia and Wolfe teaches celecoxib, a COX-2-
specific inhibitor (which has been in public use since before 1999 as
Celebrex) for treating fibromyalgia. (Final Action 3--4.) The Examiner
finds that Horrobin teaches a daily dosage range of aciclovir of 600 mg to
2000 mg. (Id. at 5.) The Examiner notes that Wolfe does not provide an
explicit dosage for celecoxib, but that the standard dose for Celebrex as
prescribed over 16 years is 200 mg. (Id.) The Examiner concludes that it
would have been obvious to one of ordinary skill in the art to combine the
use of aciclovir and celecoxib in the treatment of fibromyalgia with a
reasonable expectation of success. (Id. at 4, 6; Ans. 5.) The Examiner notes
that COX-2 inhibitors or NSAIDS "are often used in combination with other
therapies of different mechanisms of action, particularly when the disease
presents pain associated with the pathology." (Ans. 5.) The Examiner also
states "that disease pathologies can present various symptoms and it is
2 Horrobin, EP 0615750 A2, published Sept. 21, 1994.
3 Wolfe et al., Longer use of COX-2-specific inhibitors compared to
nonspecific nonsteroidal antiinjlammatory drugs: a longitudinal study of
3639 patients in community practice, 31 J Rheumatol 355-58 (2004).
4 "About Celebrex"
' http://web.archive.org/web/*/http://www.celebrex.com/about-
celebrex#quicktabs-about_celebrex=O; (last visited June 27, 2016.)
3
Appeal2018-004271
Application 14/543,403
common to provide combination therapy that address different symptoms of
the same disease." (Id.) The Examiner contends that "[a] skilled artisan
would readily glea[n] from the disclosures [ofHorrobin and Wolfe] to utilize
the benefit of both compositions to treat fibromyalgia." (Final Action 6.)
The Examiner further explains that In re Kerkhoven, which holds that it is
prima facie obvious to combine two known compounds that are taught to be
directed towards the same purpose to form a third composition for the same
purpose, further supports the conclusion that the claims are prima facie
obvious. (Id. at 4.)
We disagree with the Examiner's factual findings and conclusion of
obviousness. In particular, Wolfe does not disclose treating patients that
have fibromyalgia with celecoxib, either expressly or inherently. Wolfe
concerns a study that followed a total of 3639 patients comparing COX-2-
specific inhibitor therapy with conventional nonspecific nonsteroidal anti-
inflammatory drugs (NS NSAID). (Wolfe Abs.) In the longitudinal study,
there was an analysis of the measure of time to discontinuation of NS AID
use versus celecoxib use in patients with rheumatoid disorders. (Id. at 356-
57.) Wolfe indicates that patients in the study either were diagnosed with
rheumatoid arthritis (RA), osteoarthritis (OA) of the hip or knee, or
fibromyalgia (Wolfe 356).
As Appellant notes (Appeal Br. 8), Wolfe does not expressly disclose
patients with RA, that also had fibromyalgia, were treated with celecoxib. It
does not identify expressly that fibromyalgia patients were treated with
celecoxib or a subgroup of RA patients that also had fibromyalgia were
treated with celecoxib, or that a subgroup of OA patients with fibromyalgia
were treated with celecoxib. Rather, Wolfe simply indicates that there were
4
Appeal2018-004271
Application 14/543,403
1319 patients out of 3639 total patients of the study that were administered
celecoxib and 76.8% of them had RA. (Wolfe 356, Table 1.) However, that
does not establish that the 23 .6% of patients that did not have RA, but were
treated with celecoxib, had fibromyalgia, or that even a portion of those
23.6% had fibromyalgia. Wolfe indicates that patients in the study either
were diagnosed with RA, OA of the hip or knee, or fibromyalgia. It is
possible that the remaining 23.6% patients had OA and not fibromyalgia.
Thus, not only does Wolfe not expressly teach fibromyalgia patients were
given celecoxib, Wolfe also cannot be said to inherently teach fibromyalgia
patients were administered celecoxib because inherency may not be
established by probabilities or possibilities. Bettcher Indus., Inc. v. Bunzl
USA, Inc., 661 F.3d 629, 639 (Fed. Cir. 2011).
Consequently, the Examiner's premise underlying the obviousness of
combining two drugs known to be used to treat the same disease (Final
Action 5; Ans. 5) is not supported. Therefore, we do not sustain the
Examiner's rejection of claims 11-13 and 17-19 as being obvious.
SUMMARY
We reverse the rejection of claims 11-13 and 17-19 under 35 U.S.C.
§ 103 as being as unpatentable over Horrobin, Wolfe, and Celebrex.
REVERSED
5