Ex Parte Hastings et al

Patent Trial and Appeal Board

Oct 6, 2016

11339135 (P.T.A.B. Oct. 6, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111339,135 0112512006
4743 7590 10/11/2016
MARSHALL, GERSTEIN & BORUN LLP
233 SOUTH WACKER DRIVE
6300 WILLIS TOWER
CHICAGO, IL 60606-6357
FIRST NAMED INVENTOR
Carl W. Hastings
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.
30106/3 965 7 5370
EXAMINER
CHEN, CATHERYNE
ART UNIT PAPER NUMBER
1655
NOTIFICATION DATE DELIVERY MODE
10/11/2016 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):
mgbdocket@marshallip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CARL W. HASTINGS, DAVID J. BARNES, and
SCOTT C. KUB EL 1
Appeal 2014-001569
Application 11/339, 135
Technology Center 1600
Before ERIC B. GRIMES, JACQUELINE T. HARLOW, and
KRISTI L. R. SA WERT, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a dietary
supplement, which have been rejected as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Claims 1-10 are on appeal. Claim 1 is the only independent claim
and reads as follows:
1 Appellants identify the Real Party in Interest as Reliv International, Inc.
(Appeal Br. 3.)
Appeal2014-001569
Application 11/339, 135
1. A dietary supplement for reducing cholesterol comprising:
at least one phytosterol source;
at least one soluble fiber source;
at least one guggulsterone source;
at least one policosanol source;
an extract of Salvia miltiorrhiza; and,
an anthocyanin source.
DISCUSSION
All of the claims on appeal stand rejected under 35 U.S.C. § 103(a)
based on a combination of references that includes W eisspapir, 2 Hong, 3
Smith, 4 Howard, 5 and Guthrie6 (Ans. 4--11 ). The same issue is dispositive
for all of the rejections.
The Examiner finds that W eisspapir discloses a dietary supplement
comprising the first four ingredients of the claimed composition, specifically
"natural soluble fiber, psyllium husk ... , phytosterols, sitostanol ... ,
guggulipid (a fat mobilizing nutrient), guggul, gug[g]ulsterones ... , [and]
polycosanol, octacosanol." (Id. at 5.) The Examiner also finds that "Smith
teaches water-soluble dietary fiber compositions from oat substrate ... for
lowering serum cholesterol." (Id.)
The Examiner finds that "Hong teaches Salvia miltiorrhiza as a
pharmaceutical composition for lowering cholesterol." (Id.) The Examiner
finds that Howard "teaches supplements to prevent coronary heart disease
2 Weisspapir et al., US 2002/0103139 Al, published Aug. 1, 2002.
3 Hong et al., US 6,589,572 B2, issued July 8, 2003.
4 Smith, US 5,458,893, issued Oct. 17, 1995.
5 Howard et al., US 6,642,277 Bl, issued Nov. 4, 2003.
6 Guthrie, US 2006/0013861 Al, published Jan. 19, 2006.
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Appeal2014-001569
Application 11/339, 135
with anthocyanin-containing powder" and "Guthrie teaches flavonoids
including anthocyanins ... lowers cholesterol." (Id.)
The Examiner concludes that it would have been obvious to combine
the ingredients recited in claim 1 because "it is prima facie obvious to
combine two or more ingredients each of which is taught by the prior art to
be useful for the same purpose" (id.) and "an artisan of ordinary skill would
reasonably expect that ingredients used to control cholesterol levels could be
used as the types [of] cardiovascular health supplements taught by the
references" (id. at 6).
Appellants argue, among other things, that a person of ordinary skill
in the art would not have considered it obvious to combine an extract from
Salvia miltiorrhiza with guggul (a source of guggulsterone, as recited in
claim 1) because both of them are known anticoagulants. (Appeal Br. 6-7.)
In support of their position, Appellants cite the MedlinePlus entry for
danshen (Salvia miltiorrhiza).7 (Appeal Br. 6-7.)
We agree with Appellants that the rejection is not supported by a
preponderance of the evidence. MedlinePlus states that "[ d]anshen (Salvia
miltiorrhiza) is widely used in traditional Chinese medicine." (MedlinePlus
page 1.) MedlinePlus also states that "[b ]ecause danshen can inhibit platelet
aggregation and has been reported to potentiate (increase) the blood-thinning
effects of warfarin, it should be avoided in patients ... taking anticoagulant
(blood-thinning) drugs, herbs, or supplements." (Id.)
7 "Danshen (Salvia miltiorrhiza)," MedlinePlus, National Library of
Medicine, Sept. 1, 2005 (cited in an Information Disclosure Statement filed
June 24, 2010).
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Appeal2014-001569
Application 11/339, 135
Under the heading "Interactions with Herbs and Dietary
Supplements," MedlinePlus states that
[d]anshen may increase the risk of bleeding when taken with
herbs and supplements that are believed to increase the risk of
bleeding. Multiple cases of bleeding have been reported with the
use of Ginkgo biloba, and fewer cases with garlic and saw
palmetto. Numerous other agents may theoretically increase the
risk of bleeding, although this has not been proven in most cases.
Some examples include: ... guggul.
(Id. at page 4.)
Weisspapir discloses that "[t]he gum resin extract from the bark of
Commiphora mukul (gugul) contains a combination of steroids, diterpenoids,
alipathic esters, and carbohydrates. Of considerable pharmacological
interests are the unique steroids found in Commiphora mukul, the
guggulsterones." (Weisspapir i-f 27.) Weisspapir states that "[ e ]xperiments
showed that guggul lowered the serum cholesterol levels and body weight of
hypercholesterolemic rabbits and protected the animals against
hypercholesterolemia." (Id. i-f 28.)
Hong discloses "a composition for treating hypertension and lowering
cholesterol level, which contains the mixed extract of Panax notoginseng
and Salvia miltiorrhiza as an active ingredient." (Hong 5:14--17.) The
Examiner correctly noted (Ans. 5---6) that it is generally obvious to combine
two ingredients that are known to be useful for the same purpose (e.g.,
lowering cholesterol). However, in view of the express guidance in
MedlinePlus to avoid combining Salvia miltiorrhiza and guggul, we agree
with Appellants that the combination of ingredients recited in claim 1 on
appeal would not have been obvious to a person of ordinary skill in the art.
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Application 11/339, 135
The Examiner responded to Appellants' argument by noting that "any
nutritional compound may have side effects" (Ans. 14), but did not provide
any evidence or sound technical reasoning on which to conclude that a
skilled worker would have considered the claimed composition to be
obvious notwithstanding the specific warning in MedlinePlus against
combining guggul and a Salvia miltiorrhiza extract. We therefore conclude
that the rejection of claim 1 is not supported by a preponderance of the
evidence.
The remaining rejections on appeal also rely on the combination of
Weisspapir, Hong, Smith, Howard, and Guthrie, and on the same reasoning.
(Ans. 7-11.) For the reasons discussed above, therefore, those rejections are
also not supported by a preponderance of the evidence, and are reversed as
well.
SUMMARY
We reverse all of the rejections on appeal.
REVERSED
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