KING SAUD UNIVERSITY

Patent Trials and Appeals Board

Aug 20, 2020

15096228 - (D) (P.T.A.B. Aug. 20, 2020)

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.
15/096,228 04/11/2016 AMANI SHAFEEK AWAAD 32693.67 7923
37833 7590 08/20/2020
Richard C. Litman
Nath, Goldberg & Meyer
112 S. West Street
Alexandria, VA 22314
EXAMINER
HOFFMAN, SUSAN COE
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
08/20/2020 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):
litman@4patent.com
mbashah@nathlaw.com
uspto_nva@nathlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AMANI SHAFEEK AWAAD, GHADA MOHAMED ZAIN,
REHAM M. EL-MELIGY, AMAL AHMED SAFHI,
VIDYA DEVENATHADESIKAN SESHADRI,
SHEKHAH SAUD ALMOQREN, and NOURAH AHMED AN QURAIN1
Appeal 2020-000304
Application 15/096,228
Technology Center 1600
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and LILAN REN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of treating hypertension, which have been rejected as obvious. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellant identifies the real party in interest as KING SAUD
UNIVERSITY, RIYADH, SAUDI ARABIA. Appeal Br. 3. We use the
word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a).
Appeal 2020-000304
Application 15/096,228

2
STATEMENT OF THE CASE
The Specification states that “[c]hamomile (Matricaria chamomilla
L.) is a medicinal plant species from the Asteraceae family often referred to
as the ‘star among medicinal species.’” Spec. ¶ 18. “The present invention
relates to the treatment of hypertension, and particularly to the treatment of
hypertension using Matricaria chamomilla extracts.” Id. ¶ 1.
Claims 1 and 8–10 are on appeal. Claim 1, reproduced below, is
illustrative:
1. A method of treating hypertension, comprising
administering orally to a patient in need thereof a
therapeutically effective amount of an extract of Matricaria
chamomilla only, wherein the Matricaria chamomilla is from
the Al-Alnofood desert region of Saudi Arabia, further wherein
the therapeutically effective amount of the extract of Matricaria
chamomilla is about 100 mg/kg to about 200 mg/kg.

The claims stand rejected as follows:
Claim 1 under 35 U.S.C. § 103 as obvious based on Yagi,2 with
evidence provided by USDA3 and ITIS4 (Ans. 3) and
Claims 1 and 8–10 under 35 U.S.C. § 103 as obvious based on Jamel5
and Yagi, with evidence provided by USDA and ITIS (Ans. 5).

2 Yagi et al., US 2010/0240603 A1, published Sept. 23, 2010.
3 plants.usda.gov/core/profile?symbol=MARE6.
4 www.itis.gov/servlet/SingleRpt/SingleRpt?search_topic=
TSN&search_value=780435#null.
5 Jamel et al., US 2010/0104674 A1, published April 29, 2010.
Appeal 2020-000304
Application 15/096,228

3
OPINION
Obviousness based on Yagi, USDA, and ITIS
Claim 1 stands rejected as obvious based on Yagi, which the
Examiner cites as “teach[ing] a method of treating hypertension by
administering an extract from Matricaria recutita.” Ans. 3. The Examiner
cites USDA and ITIS as evidence that M. recutita is synonymous with
M. chamomilla. Id. The Examiner also finds that Yagi teaches administration
in dosages of 0.01 to 1000 mg/kg, preferably 0.1 to 100 mg/kg, which
overlap with the range recited in claim 1. Id. at 4.
The Examiner acknowledges that Yagi “does not specifically teach
that the chamomile plant is grown in the Al-Alnofood desert region of Saudi
Arabia.” Id. However, the Examiner concludes that
utilizing a plant grown in a particular region is considered to be
an obvious modification of the prior art. . . . Thus, the use of
M. recutita (synonymous with M. chamomilla) from the Al-
Alnofood desert region of Saudi Arabia is considered to be an
obvious modification of what was known in the art.
Id.
We agree with the Examiner that the method of claim 1 would have
been obvious based on Yagi, which discloses that “chamaemeloside
contained in Roman chamomile or German chamomile . . . inhibited the
expression of AP-1,” and “produce[d] remarkable effects on various diseases
including inflammatory diseases.” Yagi ¶ 16. Yagi states that “the
expression inhibitor . . . may contain, for example, purified chamaemeloside
or the whole or a part of Roman chamomile or German chamomile plant
body to contain chamaemeloside. An example in the former case is
Appeal 2020-000304
Application 15/096,228

4
chamaemeloside obtained by purification of an extract of Roman chamomile
or German chamomile.” Id. ¶ 25.
Yagi discloses that its expression inhibitor can be “formed into, for
example, tablets or capsules, the content can be, for example, 0.1 to 90 wt %
per tablet or capsule.” Id. ¶ 29. Yagi states that the “dose of chamaemeloside
is not limited but is preferably 0.01 to 1000 mg/kg and more preferably 0.1
to 100 mg/kg per day per adult.” Id. Yagi states that its “[p]harmaceuticals
. . . [are] for prevention or treatment of diseases in which a nuclear
transcription factor AP-1 is involved. . . . The aforementioned diseases
include at least one disease selected from the group consisting of, for
example, cancer, . . . hypertension, diabetes,” etc. Id. ¶ 39.
USDA states that the scientific name of German chamomile is
Matricaria recutita L., and synonyms include “Matricaria chamomilla L.
1755 & 1763, non 1753” and “Matricaria chamomilla L. var. coronata.”
USDA, first and third pages. Similarly, ITIS states that the common name of
Matricaria chamomilla L. is German chamomile, and synonyms include
Matricaria recutita L., “Matricaria chamomilla L. 1755 & 1763 non 1753,”
and Matricaria chamomilla var. coronata. ITIS, first page (entries for
“Synonym(s)” and “Species”).
Thus, Yagi suggests a method of treating hypertension using an
extract of German chamomile, one synonym for which is Matricaria
chamomilla, orally administered as a tablet or capsule, at a dosage of 0.01 to
1000 mg/kg.
Appeal 2020-000304
Application 15/096,228

5
Yagi does not specifically suggest obtaining the Matricaria
chamomilla from the Al-Alnofood desert region of Saudi Arabia, and
Appellant argues that
[t]he claimed species of chamomile is grown in the Al-
Alnofood desert region of Saudi Arabia and possesses different
chemical constituents and oil content. As is conventionally
known by one of ordinary skill in the art, the different chemical
constituents and oil content are due to the distinct ecological
factors. It is known in the prior art that Chamomile contains
flavonoids, volatile oils, terpenes, coumarins and tannins[ ]and
that these constituent components are responsible for the
lowering of the blood pressure. The link between the efficacy of
the constituent components and the ecological factors of the
growing region has been established by the prior art and
deserve patentable consideration, rather than being dismissed.
Appeal Br. 9.
In support, Appellant cites Liu.6 Id. However, Liu is directed to a
different plant (Sinopodophyllum hexandrum), grown in a different
geographic region (China) and having a different pharmacological effect
(anti-cancer). Appellant has pointed to no evidence showing that Matricaria
chamomilla from the Al-Alnofood desert region of Saudi Arabia differs in
any way from Matricaria chamomilla grown elsewhere; specifically, in a
way that would affect its efficacy in treating hypertension.
Appellant’s argument that “chamomile . . . grown in the Al-Alnofood
desert region of Saudi Arabia . . . possesses different chemical constituents
and oil content,” Appeal Br. 9, is thus unsupported by evidence. “Attorneys’

6 Liu et al., “Influence of Ecological Factors on the Production of Active
Substances in the Anti-Cancer Plant Sinopodophyllum hexandrum (Royle)
T.S. Ying,” PLoS One 10(4):e0122981 (2015) (abstract only).
Appeal 2020-000304
Application 15/096,228

6
argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d
1574, 1581 (Fed. Cir. 1989). We are not persuaded by Appellant’s
unsupported argument. We therefore affirm the rejection of claim 1 under 35
U.S.C. § 103 based on Yagi.
Obviousness based on Jamel, Yagi, USDA, and ITIS
Claims 1 and 8–10 stand rejected as obvious based on Jamel, Yagi,
USDA, and ITIS. The Examiner finds that “Jamel teaches a method for
treating hypertension by administering an essential oil extracted from
Matricaria recutita,” which USDA and ITIS teach is synonymous with
Matricaria chamomilla. Ans. 5. The Examiner finds that Jamel teaches oral
administration, but does not teach the dosage recited in Appellant’s claims.
Id. However, the Examiner finds that Yagi teaches a dosage of M. recutita
extract of 0.01–1000 mg/kg, preferably 0.1–100 mg/kg. Id. The Examiner
concludes that “[a]n artisan of ordinary skill would be motivated to utilize
dosages within the ranges taught by Yagi in order to determine the optimal
dosage of M. recutita to orally administer to a patient for the treatment of
hypertension as suggested by the Jamel.” Id. at 5–6.
We agree with the Examiner that the method of claim 1 would have
been obvious based on the cited references. Yagi, USDA, and ITIS are
discussed above. Jamel discloses “a composition comprising the essential oil
of Chamomilla, preferably the essential oil of Matricaria recutita L.
(Matricariae aetheroleum) and/or of the essential oil of Anthemis nobilis L.
(Matricariae romanae aetheroleum) for the treatment of hypertension.” Jamel
¶ 16. Jamel discloses oral administration. Id. ¶ 34.
Appeal 2020-000304
Application 15/096,228

7
Jamel states that “[t]he exact dosage and frequency of administration,
depend on several factors.” Id. ¶ 35. However, Yagi teaches administering
“chamaemeloside obtained by purification of an extract of Roman
chamomile or German chamomile.” Yagi ¶ 25. Yagi teaches orally
administered doses of 0.01–1000 mg/kg, preferably 0.1 –100 mg/kg, for
treating hypertension, among other disorders. Id. ¶¶ 29, 39. Thus, it would
have been obvious to use a dosage in the range suggested by Yagi in Jamel’s
method of treating hypertension. As discussed above, USDA and ITIS both
provide evidence that the Matricaria recutita discussed by Jamel is
synonymous with the Matricaria chamomilla recited in Appellant’s claims.
Appellant again argues that “[t]he claimed species of chamomile is
grown in the Al-Alnofood desert region of Saudi Arabia and possesses
different chemical constituents and oil content” from chamomile grown
elsewhere. Appeal Br. 11. However, as discussed above, Appellant’s
evidence is related to a different plant, grown in a different region, and
having a different pharmacological effect. The evidence of record does not
show that Matricaria chamomilla grown in the Al-Alnofood desert region of
Saudi Arabia differs in its composition or blood pressure-lowering effect
from Matricaria chamomilla grown elsewhere. Appellant’s unsupported
argument is therefore unpersuasive.
We affirm the rejection of claim 1 under 35 U.S.C. § 103 based on
Jamel, Yagi, USDA, and ITIS. Claims 8–10 have not been argued separately
and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Appeal 2020-000304
Application 15/096,228

8
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1 103 Yagi, USDA, ITIS 1
1, 8–10 103 Jamel, Yagi, USDA,
ITIS
1, 8–10
Overall
Outcome
1, 8–10

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED