Ex Parte Moreyra et al

Patent Trial and Appeal Board

Mar 14, 2017

13455595 (P.T.A.B. Mar. 14, 2017)

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.
13/455,595 04/25/2012 Abel Ennio Moreyra 9428C 9276
27752 7590 03/16/2017
THE PROCTER & GAMBLE COMPANY
Global IP Services
Central Building, C9
One Procter and Gamble Plaza
CINCINNATI, OH 45202
EXAMINER
HENRY, MICHAEL C
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
03/16/2017 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):
centraldocket. im @ pg. com
pair_pg @ firsttofile. com
mayer.jk @ pg. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ABEL ENNIO MOREYRA, ASHRAF M. KORAYM,
ALAN CHANEY WILSON, and OWEN RICKFORD CARRYL1
Appeal 2015-005966
Application 13/455,595
Technology Center 1600
Before MELANIE L. McCOLLUM, ULRIKE W. JENKS, and DAVID
COTTA, Administrative Patent Judges.
McCOLLUM, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
for lowering total cholesterol. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1—4 and 6—21 are on appeal (Br. 3 & 6). Claims 1, 14, and 21
are representative and read as follows:
1 Appellants identify the real party in interest as The Procter & Gamble
Company (Br. 1).
Appeal 2015-005966
Application 13/455,595
1. A method of lowering the total cholesterol level in a human
comprising administering to a human
a. at least one unit dose of cholesterol biosynthesis inhibitor selected
from the group consisting of HMG CoA reductase inhibitors, HMG Co A
synthase inhibitors, and mixtures thereof;
b. a first unit dose of soluble fiber;
c. a second unit dose of soluble fiber; and
d. a third unit dose of soluble fiber;
wherein the first unit dose of soluble fiber, the second unit dose of
soluble fiber, and the third unit dose are selected from the group consisting
of fructooligosaccharides, psyllium, oat fiber, and combinations thereof and
wherein the total cholesterol level is lowered.
14. The method according to Claim 1 wherein the cholesterol is
reduced by at least 25%.
21. A method of lowering the total cholesterol level in a human
comprising administering to a human
a. from 5 milligrams to 80 milligrams of a HMG CoA reductase
inhibitor selected from the group consisting of lovastatin, pravastatin,
simvastatin, atorvastatin, and mixtures thereof;
b. a unit dose of psyllium;
wherein the unit dose of psyllium is administered concurrently with
the HMG CoA reductase inhibitor during the evening hours.
Claims 1—4 and 6—21 stand rejected under 35 U.S.C. § 103(a) as
obvious over Broaddus2 (Ans. 5).
Claims 1—4 and 6—21 also stand rejected under 35 U.S.C. § 103(a) as
obvious over Schectman3 (Ans. 2).
2 Broaddus, WO 93/13801 Al, July 22, 1993.
3 Gordon Schectman et al., Evaluation of the Effectiveness of Lipid-
Lowering Therapy (Bile Acid Sequestrants, Niacin, Psyllium and Lovastatin)
for Treating Hypercholesterolemia in Veterans, 71 Am. J. Cardiology 759—
65 (1993).
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Application 13/455,595
I
The Examiner relies on Broaddus for disclosing “that cholesterol-
reducing agents such as lovastatin (a HMG CoA reductase inhibitor),
psyllium, cholestyramine and gemfibrozil (a HMG CoA reductase inhibitor)
can be used to treat atherosclerosis” (Ans. 6). The Examiner finds that
Broaddus discloses “that kits comprising individual primary agent
(cholesterol-reducing agents) can be used” (id.). The Examiner also finds
that Broaddus discloses “the use of 5g of psyllium and 40 mg of lovastatin (a
HMG CoA reductase inhibitor) for oral ingestion” (id.). The Examiner
concludes:
It would have been obvious ... to lower cholesterol in a human
[by] administering to a human an effective amount of a
cholesterol biosynthesis inhibitor such as Lovastatin and a
soluble fiber... and to administer [the] composition in a specific
manner or dose schedule in order to optimize the effect of said
composition or active ingredients and based on factors such as
the severity of the condition or disease and the type, age and
weight [of the] individual that is being treated.
(Id.)
Broaddus discloses:
Analysis
[a] method for reducing atherosclerotic plaque build-up in the
blood vessels of a human or animal patient in need of such
treatment, comprising administering to said patient one or more
primary agents which safely and effectively reduce a plaque-
producing member selected from the group consisting of
cholesterol, LDL triglycerides, total plasma triglycerides, or
mixtures thereof, in said patient, the improvement which
comprises additionally administering to said patient an amount
of an auxiliary agent which wholly or partially decalcifies said
plaque.
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(Broaddus 4—5.) In particular, Broaddus discloses that “cholesterol-reducing
agents such as lovastatin, psyllium, cholestyramine and gemfibrozil are used
with agents such as the diphosphonates and polycarboxylates” (id. at
Abstract). Specifically, Broaddus discloses mixtures containing both
psyllium and cholestyramine (id. at 18, 20, & 21). We agree with the
Examiner that it would have been prima facie obvious to administer both
psyllium (a soluble fiber (see claim 6)) and lovastatin (a HMG CoA
reductase inhibitor (see claim 2)).
Appellants argue, however, that “Broaddus provides no motivation to
put two primary agents in a single kit, let alone administering at least one
unit dose of cholesterol biosynthesis inhibitor and three unit doses of soluble
fiber as claimed” (Br. 6). We are not persuaded.
Broaddus discloses a method “comprising administering to said
patient one or more primary agents” (Broaddus 4—5 (emphasis added)). In
addition, as noted by the Examiner (Ans. 8), Broaddus does disclose kits,
and in fact mixtures, containing more than one primary agent —psyllium and
cholestyramine (Broaddus 18, 20, & 21).
With regard to the three unit doses of soluble fiber, we note that
claim 1 does not require that these doses be administered at different times
(see claim 10, which depends from claim 1 and recites that they are
administered concurrently). Moreover, we agree with the Examiner that it
would have been prima facie obvious “to administer [the] composition in a
specific manner or dose schedule in order to optimize the effect of said
composition or active ingredients and based on factors such as the severity
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Application 13/455,595
of the condition or disease and the type, age and weight [of the] individual
that is being treated” (Ans. 6).
Appellants also argue:
there is no motivation to administer a third unit dose of psyllium
concurrently with the cholesterol biosynthesis inhibitor during
the evening hours, as recited in claims 13, 19, and 21 or combine
the unit dose of cholesterol biosynthesis inhibitor with the third
unit dose of soluble fiber in a single composition, as recited in
claim 18.
(Br. 7.) In support of this position, Appellants point to the 2002 Label for
Metamucil® (id.). We are not persuaded.
The 2002 Label for Metamucil® states: “Laxatives, including bulk
fibers, may affect how well other medicines work. If you are taking a
prescription medicine by mouth, take this product at least 2 hours before or
2 hours after the prescribed medicine.” However, as noted by the Examiner,
this is a very general statement (Ans. 9). In addition, we agree with the
Examiner that use of the term “may” suggests that, although “laxatives,
including bulk fibers[,] may affect how well other medicines work[,] . . .
they also may not affect how well other medicines work” (id. at 8).
Furthermore, Broaddus specifically teaches a mixture of psyllium with
another cholesterol-reducing agent, cholestyramine (Broaddus 18, 20, & 21).
Thus, in the absence of a more specific teaching away, we conclude that the
evidence supports the Examiner’s conclusion that it would have been
obvious to administer psyllium and lovastatin concurrently.
Conclusion
The evidence supports the Examiner’s conclusion that Broaddus
suggests the method of claim 1. We therefore affirm the obviousness
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rejection, over Broaddus, of claim 1. Claims 2—4, 6—12, 14—17, and 20 have
not been argued separately and therefore fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
The evidence also supports the Examiner’s conclusion that Broaddus
suggests the method of claim 21. We therefore affirm the obviousness
rejection, over Broaddus, of claim 21. Claims 13, 18, and 19 are argued
with that therefore fall with claim 21. Id.
II
The Examiner relies on Schectman for disclosing “a method of
treating a condition associated with elevated cholesterol levels
(hypercholesterolemia) by lowering cholesterol comprising administering to
a mammal in need of such treatment an effective amount of a cholesterol
biosynthesis inhibitor (lovastatin)” (Ans. 3). The Examiner finds that
Schectman “treats said condition associated with elevated cholesterol levels
(hypercholesterolemia) by administering to a mammal the soluble fiber,
psyllium” (id.). The Examiner concludes:
It would have been obvious ... to lower cholesterol in a human
[by] administering to a human an effective amount of a
cholesterol biosynthesis inhibitor such as Lovastatin and a
soluble fiber such as psyllium and to administer [the]
composition in a specific manner or dose schedule in order to
optimize the effect of said composition or active ingredients and
based on factors such as the severity of the condition or disease
and the type, age and weight [of the] individual that is being
treated.
(Id. at 4.)
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Analysis
Schectman discloses treating hypercholesterolemia using bile acid
sequestrants, niacin, psyllium, or lovastatin (Schectman 759). We agree
with the Examiner that it would have been prima facie obvious to treat
hypercholesterolemia with two or more of these agents. In re Kerkhoven,
626 F.2d 846, 850 (CCPA 1980) (“It is prima facie obvious to combine two
compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition which is to be used for
the very same purpose.”). Thus, we agree with the Examiner that it would
have been prima facie obvious to administer both psyllium and lovastatin.
Appellants argue, however, that “[sjince Schectman discloses that
only minimal LDL cholesterol reductions were achieved with psyllium,
Schectman does not motivate one skilled in the art to administer both a
cholesterol biosynthesis inhibitor and soluble fiber” (Br. 5). We are not
persuaded.
We understand that Schectman teaches that psyllium had only a
relatively small effect on total cholesterol and LDL cholesterol
(Schectman 762: Table IV). Nevertheless, it did reduce both (id.). Thus, we
do not agree that Appellants have demonstrated that one of ordinary skill in
the art would not have used psyllium together with lovastatin.
Appellants also argue that “Schectman provides no motivation for
lowering the total cholesterol by at least 25% (claim[] 14 . . .) or 30%
(claim 15)” (Br. 5). We are not persuaded.
As noted by Appellants, “Schectman discloses that lovastatin
produced the largest reductions in total cholesterol (-21%), while, psyllium
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Application 13/455,595
had the least decline (-2%)” (id. (citing Schectman 762: Table IV)).
However, we agree with the Examiner that it would have been obvious to
further reduce total cholesterol through, for example, higher doses (Ans. 17;
see also Schectman 762: Table V, where high-dose lovastatin alone provided
a reduction in total cholesterol of -22.7 ±2.1). In this regard, we note that
Appellants have not provided persuasive evidence that the methods of
claims 14 and 15, which do not require administration of the cholesterol
biosynthesis inhibitor within 2 hours of the soluble fibers, provide a
“surprising” result (Br. 5).
In addition, Appellants argue:
[Tjhere is no motivation to administer a unit dose of psyllium
concurrently with the cholesterol biosynthesis inhibitor during
the evening hours, as recited in claims 10, 13, 19, and 21, or to
combine the unit dose of cholesterol biosynthesis inhibitor with
the third unit dose of soluble fiber in a single composition, as
recited in claim 18.
(Br. 3 4.) As with the above rejection, Appellants point to the 2002 Label
for Metamucil® to support their position (id. at 3). We conclude that
Appellants have the better position.
In this case, the Examiner has pointed to nothing in Schectman that
points towards concurrent administration. However, Appellants have
pointed to something that, albeit generally, teaches away from doing so. The
Examiner may be relying on Broaddus to provide support for concurrent
administration (Ans. 8 (“It should be noted that the rejections set forth above
were made by applying Schectman et al. and also applying Broaddus”).
However, given the Metamucil® Label and that Broaddus was not included
in this rejection, we conclude that the Examiner has not adequately
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explained why it would have been obvious to administer the psyllium
concurrently with the lovastatin.
Conclusion
The evidence supports the Examiner’s conclusion that Schectman
suggests the methods of claims 1, 14, and 15. We therefore affirm the
obviousness rejection, over Schectman, of claims 1,14, and 15. Claims 2-4,
6—9, 11, 12, 16, and 17 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
However, the evidence does not support the Examiner’s conclusion
that Schectman suggests the methods of claims 10,4 13, 18, 19, and 21. We
therefore reverse the obviousness rejection, over Schectman, of claims 10,
13, 18, 19, and 21. Because claim 20 depends from claim 19, we also
reverse this rejection of claim 20.
SUMMARY
We affirm the obviousness rejection of claims 1—4 and 6—21 over
Broaddus. We also affirm the obviousness rejection of claims 1—4, 6—9, 11,
12, and 14—17 over Schectman. However, we reverse the obviousness
rejection of claims 10, 13, and 18—21 over Schectman.
4 We note that claim 10 does not recite that the administration is during the
evening hours, as argued by Appellants (Br. 3—4). However, because the
basis of our reversal does not depend on the administration being during the
evening hours, we have included claim 10 in the group of reversed claimed.
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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).
AFFIRMED
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