Ex Parte Crede

Patent Trials and Appeals Board

Jun 18, 2019

14240759 - (D) (P.T.A.B. Jun. 18, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/240,759 02/25/2014 Philipp Crede
23550 7590 06/20/2019
HOFFMAN WARNICK LLC
540 Broadway
4th Floor
ALBANY, NY 12207
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.
CN0-0001-US 8881
EXAMINER
FAY,ZOHREHA
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
06/20/2019 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):
PTOCommunications@hoffmanwarnick.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIPP CREDE 1
Appeal2018-004942
Application 14/240, 7 59
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and JAMIE T. WISZ,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant identifies Crede Oils (Pty) Ltd. as the real party-in-interest.
App. Br. 1.
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Application 14/240,759
SUMMARY
Appellant files this appeal under 35 U.S.C. § I34(a) from the
Examiner's Final Rejection of claims 1, 3, 4, 6-11, and 22-24 as
unpatentable under 35 U.S.C. § I03(a) as being obvious over the
combination of Crede (US 6,531,164 B 1, March 11, 2003) ("Crede"), I.
Tekeoglu et al., Effects of Thymoquinone (Volatile Oil of Black Cumin) on
Rheumatoid Arthritis in Rat Models, 20 PHYTOTHER. RES. 869-71 (2006)
("Tekeoglu"), Pacioretty et al., (US 2010/0028468 Al, February 4, 2010)
("Pacioretty"), and Bruzzese (US 2010/0160435 Al, June 24, 2010)
("Bruzzese").
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellant's claimed invention is directed to the treatment of
inflammatory diseases and disorders and, more particularly, to the treatment
of symptoms of inflammatory diseases and disorders using thymoquinone
("TQ") alone or in combination with other compounds, including
eicosapentaenoic acid ("EPA"). Abstr.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A method of treating at least one symptom of an
inflammatory disease or disorder in an individual in need of such
treatment, the method comprising:
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administering to the individual an amount of
thymoquinone between about 1 mg/day and about 800 mg/day;
and
administering to the individual a quantity of
eicosapentaenoic acid,
wherein the inflammatory disease or disorder is selected
from a group consisting of: psoriasis, psoriatic arthritis, multiple
sclerosis, and osteoarthritis.
App. Br. 6.
ISSUES AND ANALYSES
We adopt the Examiner's findings, reasoning, and conclusion that the
claims are primafacie obvious over the cited prior art. We address the
arguments raised by Appellant below.
Issue 1
Appellant argues that the Examiner erred in finding that Pacioretty
teaches or suggests: "the use of thymoquinone as an inflammatory [sic]
agent for the treatment of inflammation and infection," and that: "[ t ]he
amount of thymoquinone is taught in table 1, Para [0020], [0022] and
[0060], which is taught to be 1-27-57% [sic] and 5mg/kg." App. Br. 2
( alterations in original) ( quoting Final Act. 3 ).
Analysis
The Examiner finds that Crede teaches the use of a pharmaceutical
preparation of black cumin (Nigella sativa) oil in combination with omega 3
fatty acids for the treatment of psoriasis. Final Act. 3 ( citing Crede Abstr.,
Examples). The Examiner finds that Tekeoglu teaches that thymoquinone is
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a main ingredient of the seeds of Nigella sativa and that, therefore, it follows
that the extracts taught by Crede contain thymoquinone. Id. The Examiner
finds that Crede differs from the claimed invention in the amounts of
administered thymoquinone and in the presence of eicosapentaenoic acid.
Id.
The Examiner finds, however, that Pacioretty teaches the use of
thymoquinone as an inflammatory agent for the treatment of inflammation
and infection in amounts that are within the range recited in the claims.
Final Act. 3 ( citing Pacioretty ,r,r 3, 20, 22, 60, Table 1 ).
The Examiner finds that Bruzzese teaches the use of eicosapentaenoic
acid for the treatment of different disorders, including psoriasis. Final Act. 3
( citing Bruzzese Abstr., claim 30). The Examiner finds that the amount of
EPA used is taught in Example 4. Id.
The Examiner concludes that it would have been obvious to a person
of ordinary skill in the art to combine eicosapentaenoic acid, as taught by
Bruzzese, with the thymoquinone composition of Crede and Pacioretty,
because the references teach compositions used for the same purpose, i.e.,
the treatment of inflammatory diseases or disorder, including psoriasis.
Final Act. 3--4 (citing In re Kerkhoven, 626 F.2d 846, 850 (C.C.P.A. 1980)
(holding that: "It is prima facie obvious to combine two compositions each
of which is taught by the prior art to be useful for same purpose, in order to
form a third composition which is to be used for the very same purpose")).
Appellant points to the passages of Pacioretty relied upon by the
Examiner and argues that these passages teach administration of quantities
of thymoquinone up to 50 times less than that alleged by the Examiner.
App. Br. 2 (citing Pacioretty ,r,r 20, 22, 60). According to Appellant, these
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paragraphs teach that the thymoquinone content of Pacioretty' s supplement
is distinguishably lower than what the Examiner alleges. Id. at 3. Appellant
asserts that a dose of 1 to 5 mg/kg of a thymoquinone formulation that
contains 2% to 6% thymoquinone constitutes an absolute amount of
thymoquinone of between 0.02 mg/kg thymoquinone (1 mg/kg dose of a
formulation containing 2% thymoquinone) and 0.3 mg/kg thymoquinone (5
mg/kg dose of a formulation containing 6% thymoquinone ). Id. Assuming
a body mass of 50 kg, Appellant argues, this results in a dosage of between
1.0 mg/day and 15 mg/day. Id. Appellant points out that this is below the
doses in, e.g., claims 3 and 4.
Appellant contends that much of the disagreement between the
Examiner and Appellant appears to stem from a misapplication or
miscalculation of the relevant concentrations disclosed in the cited prior art.
App. Br. 3. Appellant argues, by way of example, that the Examiner finds
that: "Pacioretty in Para[0020] teaches that the extract of sativa has 2.0-6%
thymoquinone. Such amounts equals [sic] to 20-60 mg/ml, which is within
the scope of the claims amounts [sic]." App. Br. 3 (alterations in original)
( quoting Final Act. 3). Appellant contends that the claims do not recite a
concentration of thymoquinone ( whether as a percentage or as mg/ml), but
rather recite a dosage expressed in absolute terms, i.e., mg/day. Id.
Appellant argues further that the Examiner's finding that any body
mass may be considered in order to reach the claimed thymoquinone doses
is impractical. App. Br. 3. For example, argues Appellant, by using
Pacioretty's concentrations, reaching the upper limit of the dosage range
recited in claim 1, would require an individual possessing a body mass of
2,667 kg. Id. Even the upper limit of the dosage range recited in claim 3,
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Appellant asserts, would still require an individual body mass of 400 kg (880
pounds).
Appellant contends that there is nothing in Pacioretty that teaches or
suggests that the compositions described therein were contemplated for
administration to individuals of such unrealistic body masses. App. Br. 3.
Rather, argues Appellant, Pacioretty intended the compositions to be
administered to individuals having typical body masses, and that therefore
the compositions contain a much lower total dose of thymoquinone than that
claimed by Appellant. Id.
The Examiner responds that Pacioretty teaches an extract of N. sativa
that is effective in treating inflammation and which contains 2-6% (w/w)
thymoquinone. Ans. 6. The Examiner calculates that 2---6% (w/w)
thymoquinone equals 2---6 g/100 ml, which equals 20-60 mg/1, or 20---60
mg/1.1 ml of oil (where the density of the oil equals 0.9 g/ml), or 18-55
mg/ml of oil. 2 Id. Therefore, reasons the Examiner, to obtain 50 mg
thymoquinone daily, an individual would need to consume between 0.9 ml
(6.0% w/w) and 2.7 ml (2.0% w/w) of thymoquinone in a dietary
supplement per day. Similarly, to obtain a daily dosage of 250 mg
thymoquinone, an individual would need to consume between 4.5 ml (6.0%
w/w) and 13.5 ml (2.0% w/w) per day. Id. The Examiner finds that such
amounts are within the scope of the amounts of thymoquinone recited in the
claims.
We agree with the Examiner's calculations, and are consequently not
persuaded by Appellant's arguments. Pacioretty teaches: "A novel,
2 1.0 milliliters of water has a mass of 1.0 grams.
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supercritical CO2 extract of N. sativa has is [sic] described that contains 2.0
to 6.0% (w/w) thymoquinone, an amount between that of the fixed and
essential oils, and exhibits anti-inflammatory activity in excess of its
thymoquinone content alone." Pacioretty ,r 20.
Even at the upper end of the range recited in claim 1 (800 mg), a
person would need to consume a mere 14.5 mls of a 6% thymoquinone
extract, approximately one tablespoonful, 3 to consume the required amount.
Such an amount is, Appellant's reasoning to the contrary notwithstanding,
hardly an impractical amount, even when included as part of a dietary
supplement. See Pacioretty ,r,r 22, 60.
Appellant's reasoning founders principally in attempting to determine
a dosage in terms of dosage as a function of mg/kg body mass per day. No
such dosage is recited in the claims; rather, the dosage recited is in absolute
terms of grams per day, regardless of body mass. We are consequently not
persuaded by Appellant's arguments with respect to this issue.
Issue 2
Appellant argues that the Examiner erred in failing to provide a reason
why a person of ordinary skill would have been motivated to combine the
references. App. Br. 4.
Analysis
Appellant argues that the Examiner has pointed to no motivation why
a person of ordinary skill would have combined the references, and
3 1 tablespoon of measure equals 14.8 mls.
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Appellant asserts that there is none. App. Br. 4. According to Appellant,
Pacioretty describes dietary supplements, including 2---6% thymoquinone
extracts, for treating "lower urinary tract disorders or to support normal
urinary tract function in animals." Id. ( quoting Pacioretty Abstr.). Appellant
contends that, even if one were to accept, arguendo, that Crede and Bruzzese
teach compounds or compositions used for the same purpose, Pacioretty's
compositions are clearly used for an entirely different purpose, and one for
which a person of skill in the art would not find a counterpart in Crede or
Bruzzese. Id.
Appellant argues that the Examiner has stated that the anti-
inflammatory properties of Pacioretty' s compositions are enough to motivate
its combination with the other references. App. Br. 4. However, Appellant
contends, this is at odds with the rejection itself. Appellant asserts that there
is no mention in Pacioretty of the treatment of psoriasis or any of the other
disorders described by Crede and Bruzzese, and Appellant contends that the
Examiner, therefore, cannot find that the compositions are being used for the
same purpose. Id. Appellant therefore contends that there is no motivation
to combine the teachings of the references to be found in either the
references themselves or the knowledge of one of ordinary skill in the art.
Id.
We are not persuaded. Appellant's independent claim 1 recites, in
relevant part: "A method of treating at least one symptom of an
inflammatory disease or disorder ... wherein the inflammatory disease or
disorder is selected from a group consisting of: psoriasis, psoriatic arthritis,
multiple sclerosis, and osteoarthritis." Pacioretty teaches that: "A novel,
supercritical CO2 extract of N. sativa has is described that contains 2.0 to
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6.0% (w/w) thymoquinone, an amount between that of the fixed and
essential oils, and exhibits anti-inflammatory activity in excess of its
thymoquinone content alone." Pacioretty ,r 20 ( emphasis added). Similarly,
Tekeoglu expressly teaches that it is well known in the art that extracts of N.
sativa containing thymoquinone possess anti-inflammatory properties.
Tekeoglu Abstr. ("Many studies have been carried out in recent years on the
pharmacological effects of [NJ igella sativa seeds that have uncovered their
antiinflammatory and immunological effects"). Bruzzese teaches that
eicosapentaenoic acid is known in the art for its efficacy in teaching
inflammatory conditions, including, e.g.,: "autoimmune diseases, tumour
diseases, arthritis, connective tissue diseases, Crohn disease, psoriasis, and
several other illnesses shown in the literature, all that in analogy with the use
of similar compositions." Bruzzese ,r 57; see also ,r 10 (citing, e.g., R.A.
Lewis et al., The Biologically Active Leukotrienes. Biosynthesis,
Metabolism, Receptors, Functions, and Pharmacology, 73(4) J. CLIN.
INVEST. 889--97 (1984) ("Lewis") (effectiveness of EPA in treating
rheumatoid arthritis, connective tissue disease and inflammation)). We
agree with the Examiner that a person of ordinary skill, understanding that
the thymoquinone compositions of Pacioretty exhibit anti-inflammatory
activity, would have had reason and been motivated, and with a reasonable
expectation of success, to combine the thymoquinone compositions with
those of Bruzzese, which also exhibit such activity, in the treatment of
inflammatory diseases or disorders, including psoriasis. We consequently
affirm the Examiner's rejection of claims.
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DECISION
The Examiner's rejection of claims 1, 3, 4, 6-11, and 22-24 under 35
U.S.C. § 103(a) is affirmed.
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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