William L. Pridgen

Patent Trials and Appeals Board

Nov 25, 2019

13761079 - (D) (P.T.A.B. Nov. 25, 2019)

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.
13/761,079 02/06/2013 William L. Pridgen 16210-000006-US 3588
28997 7590 11/25/2019
Harness Dickey (St. Louis)
7700 Bonhomme, Suite 400
ST. LOUIS, MO 63105
EXAMINER
TRAN, MY CHAU T
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
11/25/2019 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):
bkamer@hdp.com
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. PRIDGEN
____________

Appeal 2018-002182
Application 13/761,0791
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, CHRISTOPHER G. PAULRAJ, and
DAVID COTTA, Administrative Patent Judges.

COTTA, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134 involving claims to a method
to treat a subject afflicted with one or more functional somatic syndrome
conditions. The Examiner rejected the claims on appeal as obvious under 35
U.S.C. § 103(a). We affirm-in-part.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. According to Appellant, the real party in interest is
Innovative Med. Concepts, Inc. App. Br. 3.

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Application 13/761,079

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STATEMENT OF THE CASE
The Specification states that “[t]he present invention relates to
pharmaceutical compositions and methods of treating functional somatic
syndromes using combination therapies.” Spec. ¶ 2.
Claims 19–28 are on appeal. Claims 19, 22, and 23 are representative
and read as follows:
19. A method to treat a subject afflicted with one or more
functional somatic syndrome conditions, the method comprising
administering to the subject in need thereof a therapeutically-
effective combination of famciclovir and meloxicam,
wherein the amount of famciclovir is administered in a total
daily dose range from about 250 mg to about 2000 mg,
wherein the amount of meloxicam is administered in a total
daily dose range from about 7.5 mg to about 30 mg, and
wherein the one or more functional somatic syndrome
conditions is selected from the group consisting of fibromyalgia,
chronic fatigue syndrome, irritable bowel syndrome, chronic
depression, chronic clinical anxiety disorder and chronic interstitial
cystitis.

22. A method to treat a subject afflicted with irritable bowel
syndrome, the method comprising
administering to the subject in need thereof a therapeutically-
effective combination of famciclovir and meloxicam,
wherein the amount of famciclovir is administered in a total
daily dose range from about 250 mg to about 2000 mg, and
wherein the amount of meloxicam is administered in a total
daily dose range from about 7.5 mg to about 30 mg.

23. A method to treat a subject afflicted with a combination of
fibromyalgia, chronic fatigue syndrome and irritable bowel syndrome,
coexistent in the subject, the method comprising
administering to the subject a therapeutically-effective
combination of famciclovir and meloxicam,
wherein the amount of famciclovir is administered in a total
daily dose range from about 250 mg to about 2000 mg, and
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wherein the amount of meloxicam is administered in a total
daily dose range from about 7.5 mg to about 30 mg.
App. Br. 16–17.
The claims stand rejected as follows.
Claims 19–21, and 24–28 were rejected under 35 U.S.C. § 103(a) as
being obvious over the combination of Maziasz2 and Payne.3
Claims 22 and 23 were rejected under 35 U.S.C. § 112 for failure to
comply with the enablement requirement.
ENABLEMENT
In rejecting claims 22 and 23 for failure to comply with the
enablement requirement, the Examiner reviewed the factors delineated in In
re Wands USPQ 2d 1400 (CAFC 1988). In particular, the Examiner found
that the art with respect to irritable bowel syndrome (“IBS”) was
“unpredictable because there are no known structural abnormalities, specific
laboratory tests, and/or biological markers for the condition/disease.” Ans. 9
(addressing claim 22), 12 (addressing claim 23). According to the
Examiner, IBS is diagnosed solely based on symptoms and thus “it would be
difficult to determine the therapeutic effectiveness of the . . . combination of
famciclovir and meloxicam . . . and/or their specific claimed ‘dose range’
for the condition/disease of irritable bowel syndrome (IBS).” Id. The
Examiner also found that the only treatment exemplified and the only
guidance provided in the Specification was for treating patients with
fibromyalgia. Id. Accordingly, the Examiner concluded that “the quantity

2 Maziasz, US Patent Publication No. 2004/0157848 A1, published Aug. 12,
2004 (“Maziasz”).
3 Payne, A New Fibromyalgia Remedy: Antiviral Drugs, U.S. News & World
Report, published April 11, 2008 (“Payne”).
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of experimentation needed to make and or use the invention would be great.”
Id. at 10, 13. We are not persuaded.
“[T]o be enabling, the specification of a patent must teach those
skilled in the art how to make and use the full scope of the claimed invention
without ‘undue experimentation.’” In re Wright, 999 F.2d 1557, 1561 (Fed.
Cir. 1993).
The enablement requirement ensures that the public knowledge
is enriched by the patent specification to a degree at least
commensurate with the scope of the claims. The scope of the
claims must be less than or equal to the scope of the enablement.
The scope of enablement, in turn, is that which is disclosed in the
specification plus the scope of what would be known to one of
ordinary skill in the art without undue experimentation.

National Recovery Techs. Inc. v. Magnetic Separation Sys., Inc., 166 F.3d
1190, 1195–96 (Fed Cir. 1999).
The Examiner bears the burden of explaining why the scope of
protection claimed is not adequately enabled by the description of the
invention provided in the specification including, “providing sufficient
reasons for doubting any assertions in the specification as to the scope of
enablement.” In re Wright, 999 F.2d 1557, 1561–62 (Fed. Cir. 1993).
Appellant has persuaded us that the Examiner has not carried this burden.
The Specification discloses a method of treating functional somatic
syndrome conditions including irritable bowel syndrome by “administering
to the subject a therapeutically-effective combination of famciclovir and
meloxicam.” Spec. ¶ 32. Famciclovir is an antiviral compound. Id. ¶ 13.
The Specification also discloses dosage ranges for the antiviral compound
(Spec ¶¶ 104–106) and for meloxicam. Id. ¶ 122; see also, id. ¶¶ 115–117.
The Examiner asserts that “there are no known structural abnormalities,
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specific laboratory tests, and/or biological markers for [IBS].” Ans. 9, 14.
Appellant disputes this (App. Br. 7), but we need not determine whether the
Examiner is correct because the Examiner’s assertion does not provide
“sufficient reasons for doubting” the assertion in the Specification that
irritable bowel syndrome can be treated by administering a combination of
famciclovir and meloxicam. In re Wright, 999 F.2d at 1561–62. Appellant
claims a method of treatment, not a method of diagnosis. As Appellant
points out, “[a] patient seeking treatment does not particularly care about
biomarker levels and merely wants the symptoms to resolve.” App. Br. 7.
Because the Examiner’s assertion does not provide a sufficient evidentiary
basis on which to doubt that the symptoms of IBS can be treated by
administering a combination of famciclovir and meloxicam as claimed, we
reverse the Examiner’s rejection of claims 22 and 23 for failure to comply
with the enablement requirement.
OBVIOUSNESS
Appellant argues claims 19–21 and 24–28 together. We designate
claim 19 as representative.
Maziasz discloses “a method and a composition for the treatment of a
herpes virus infection as well as associated diseases and related disorders”
by “administering to the subject a cyclooxygenase-2 selective inhibitor . . .
and an anti-herpes virus agent.” Maziasz ¶ 10. More specifically, Maziasz
discloses that the combination of a cyclooxygenase-2 selective inhibitor and
an anti-herpes virus agent may be used to treat the herpes virus known as
cytomegalovirus (“CMV”). Id. ¶¶ 3, 453. In Table C3, Maziasz discloses
120 “suitable combinations” of cyclooxygenase-2 inhibitors and anti-herpes
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virus agents including the claimed combination of meloxicam and
famciclovir. Id. ¶ 448.
Payne provides a review of the book The New Fibromyalgia Remedy:
Stop Pain Now with an Anti-Viral Drug Regimen, by Daniel C. Dantini. It
discloses that Dantini “believes that fibromyalgia is caused by the Epstein-
Barr virus, cytomegalovirus, herpesvirus 6, or parvirus.” Payne. Payne
quotes Dantini as teaching that fibromyalgia can be treated by
“[c]ontrol[ing] the viruses using the antiviral drugs famciclovir (brand name
Famvir) or valacyclovir (Valtrex).” Id.
In finding claim 19 obvious, the Examiner concluded that it would
have been obvious to treat fibromyalgia by treating cytomegalovirus, one of
the viral illnesses that Payne teaches is “linked to the condition of
fibromyalgia,” using the combination of meloxicam and famciclovir as
taught by Maziasz. Ans. 6. The Examiner finds that an ordinary artisan’s
reasonable expectation that such treatment would be successful would have
been furthered by Maziasz’s teaching that the patients to be treated may
have an autoimmune disease. Id. (citing Maziasz ¶¶ 457–458 (which
disclose “the subject may have a depressed immune response, such as . . . a
subject with an autoimmune disease” and that a further aspect of Maziasz’s
invention involves “treat[ing] herpes related disorders” including
“myalgia.”) .
With respect to the claimed dosages, the Examiner found that Maziasz
disclosed a famciclovir dosage range falling within that recited in claim 19
and a cyclooxygenase 2-selective inhibitor dosage range that “substantially
overlap[s] the . . . claimed range.” Ans. 4–5.
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We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 3–7; Final Act.4 2–7) and agree that
claims 19–21 and 24–28 would have been obvious over the combination of
Maziasz and Payne. We address Appellant’s arguments below.
Appellant argues that “[t]he Examiner bears the burden of showing
that the Claim 19 combination [of famciclovir and meloxicam] is no
different than any other combination in Maziasz.” App. Br. 10. Appellant
contends that the Examiner’s rejection cannot stand on the premise that it
would have been obvious to select one from among the many combinations
disclosed in Maziasz to treat fibromyalgia when there is no teaching that any
of those combinations can be used to treat fibromyalgia. Id. We are not
persuaded.
Maziasz discloses a number of combinations of compounds that are
useful for treating cytomegalovirus. Maziasz ¶¶ 448, 453. It would have
been obvious to select any one of the combinations of compounds disclosed
for the purpose of treating cytomegalovirus. Sinclair & Carroll Co. v.
Interchemical Corp. 325 U.S. 327, 335 (1945) (“Reading a list and selecting
a known compound to meet known requirements is no more ingenious than
selecting the last piece to put into the last opening in a jig-saw puzzle.”).
There was no need for the Examiner to find a teaching in Maziasz that its
combinations of compounds can be used to treat fibromyalgia because Payne
discloses that fibromyalgia is caused by cytomegalovirus and may be treated
by controlling the virus with antiviral drugs. See generally Payne. Given
Payne’s teaching linking fibromyalgia to cytomegalovirus, we agree with the
Examiner that it would have been obvious to select one of the combinations

4 Office Action mailed February 10, 2017 (“Final Act.”).
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of compounds disclosed in Maziasz as useful for treating cytomegalovirus to
treat fibromyalgia.
Appellant argues that the ordinary artisan would have expected
different combinations of compounds disclosed in Maziasz’s Table C3 to
behave differently with respect to CMV. App. Br. 10. Appellant relies on
the following passage from Maziasz:
Typically when the subject is a human, the composition is
employed to treat or prevent herpes simplex virus type 1 (HSV-
1), herpes simplex virus type 2 (HSV-2), cytomegalovirus
(CMV), and varicella zoster virus (VZV) infections. Even more
typically when the subject is a human, the composition is
utilized to treat or prevent either a HSV-1 or a HSV-2 infection.
Maziasz ¶ 453. Based on this passage, Appellant argues that “the particular
focus on HSV-1/2,” which Payne does not teach as being relevant to
fibromyalgia, “suggests that some of the combo-treatments work better
against HSV-1/2 than against CMV.” App. Br. 10. Appellant thus argues
that “one of ordinary skill would not expect, based on the combined
teachings of Maziasz and Payne, that all drug combinations listed in Maziasz
would be effective for treating functional somatic syndrome disorders.” Id.
at 10–11. We are not persuaded because we do not interpret the disclosure
in Maziasz that its compositions are “more typically” used to treat HSV-1
and HSV-2 as teaching or suggesting that any of its compositions are not
useful for treating CMV. Moreover, even if some of Mazaisz’s
compositions were better at treating CMV than others—a proposition not
supported by persuasive evidence—that does not render the choice of any
one of the compositions non-obvious. In re Mouttet, 686 F.3d 1322, 1334
(Fed. Cir. 2012) (“[J]ust because better alternatives exist in the prior art does
not mean that an inferior combination is inapt for obviousness purposes.”).
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Appellant argues that the use of meloxicam to “block[] viral
replication by simultaneous inhibition of COX-1 and COX-2” is critical to
the claimed method. App. Br. 11. Appellant then argues that Maziasz does
not provide any motivation to select balanced COX-enzyme dual-inhibition
as would be provided by a combination treatment including meloxicam. Id.
We are not persuaded because Maziasz expressly discloses the combination
of meloxicam and famciclovir. Maziasz ¶ 448.
Appellant argues that Dantini’s book, which Payne reviews,
“explicitly prescribes cessation of pain medicines,” which would include
meloxicam, for treating fibromyalgia patients. App. Br. 13. Appellant
argues that this strongly teaches away from the claimed method. Id. We are
not persuaded.
As an initial matter, Appellant does not provide any citation to any
specific passage in Dantini’s book,5 leaving us to speculate about which
passage(s) Appellant contends teach away from the claimed method.
Regardless, we are not persuaded that Dantini teaches away from the
claimed method.
Dantini discloses that many fibromyalgia patients are “taking other
medications – antidepressants, pain medicines, or other prescriptions – for
their fibromyalgia symptoms when we begin the antiviral protocol” and
further teaches “withdraw[ing] those medications slowly during the course
of treatment.” Dantini 89 (emphasis added). Dantini thus expressly
contemplates that treatment with a pain medication may continue during

5 References to Dantini are to the reference provided with the Information
Disclosure Statement, filed on January 6, 2015. The copy provided was not
a complete copy. We did not consider any portions of Dantini that were not
of record.
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antiviral treatment. See also, id. (“I don’t advise individuals to go cold
turkey with any medication, but suggest they withdraw from it gradually”).
In addition, Dantini expressly teaches that “NSAIDs are fine for minor
temporary relief but the pain in fibromyalgia returns.” Dantini 69. Finally,
Appellant’s argument assumes that the only effect of meloxicam is to treat
pain. However, Mazaisz suggests that COX-2 inhibitors, like meloxicam,
are not just pain medications, but can have antiviral effects. See Mazaisz ¶ 7
(“Treatment of the cytomegalovirus infected fibroblasts with a
cyclooxygenase-2 selective inhibitor, however, reduced the yield of virus in
the cells by a factor of about 100.”)
Appellant argues that claim 19 recites a meloxicam dosage in
milligrams per day while the Examiner’s Answer “cites a disclosure of
cyclooxygenase-2-selective inhibitor dosage presented in terms of
milligrams per kilogram body weight per day.” Reply. Br. 2. Appellant
further argues that even if the cited doses are translated to a daily dose in
milligrams by using an average U.S. body mass of 70 kg2, the resulting
ranges are “so absurdly broad as to be of no use at all to a skilled person for
purposes of dosing meloxicam.” Id. at 3 (calculating ranges of “70 mg to
1400 mg per day,” “700 μg to 7 kg per day,” and “between about 7 mg and
about 3.5 kg per day”). We are not persuaded.
While the Examiner’s Answer quotes dosages that are provided in
mg/kg, the Examiner cites to paragraph 412 of Maziasz. Ans. 15. Paragraph
412 of Mazaisz states:
The amount of active ingredient that can be combined with the
carrier materials to produce a single dosage of the
cyclooxygenase-2 selective inhibitor will vary depending upon
the patient and the particular mode of administration. In
general, the pharmaceutical compositions may contain a
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cyclooxygenase-2 selective inhibitor in the range of about 0.1
to 2000 mg, more typically, in the range of about 0.5 to 500
mg and still more typically, between about 1 and 200 mg. A
daily dose of about 0.01 to 100 mg/kg body weight, or more
typically, between about 0.1 and about 50 mg/kg body weight
and even more typically, from about 1 to 20 mg/kg body
weight, may be appropriate. The daily dose is generally
administered in one to about four doses per day.
Maziasz ¶ 412 (emphasis added). As is readily apparent, the cited paragraph
provides doses in both mg and in mg/kg. The doses provided in mgs overlap
with those recited in claim 19. As Appellant has not provided evidence
demonstrating that the claimed range is critical, we agree with the Examiner
that the claimed range would have been obvious based on the disclosure of
Maziasz. See In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir.
1990).
Accordingly, we affirm the Examiner’s rejection of claims 19.
Because they were not argued separately, we also affirm the Examiner’s
rejection of claims 20, 21, and 24–28.
SUMMARY
In summary:

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
22, 23 Enablement 22, 23
19–21, 24–28 103(a) Maziasz, Payne

19–21, 24–
28

Overall
Outcome
19–21, 24–
28
22, 23

AFFIRMED-IN-PART