Ex Parte Pak

Patent Trial and Appeal Board

Sep 25, 2018

11673497 (P.T.A.B. Sep. 25, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/673,497 02/09/2007
32425 7590 09/27/2018
NORTON ROSE FULBRIGHT US LLP
98 SAN JACINTO BOULEVARD
SUITE 1100
AUSTIN, TX 78701-4255
FIRST NAMED INVENTOR
Charles Y.C. Pak
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.
UTSD.Pl831US/l ll 13030 2807
EXAMINER
SPRINGER, STEPHANIE K
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
09/27/2018 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):
aoipdocket@nortonrosefulbright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Exparte CHARLES Y.C. PAK
Appeal2017-009636
Application 11/673,497 1
Technology Center 1600
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
DAVID COTTA, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1, 3-6, 13-17,
19-21, 23-25, 27, 30, and 32 (Final Act. 2). 2 Examiner entered rejections
under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
1 Appellant identifies "BOARD OF REGENTS, THE UNIVERSITY OF
TEXAS SYSTEM" as the real party in interest (Br. 2).
2 Office Action mailed April 21, 2016.
Appeal2017-009636
Application 11/673,497
STATEMENT OF THE CASE
Appellant's disclosure relates "to the field of treatments for
hypertension, and more particularly, to compositions and methods for
supplementing a Dietary Approaches to Stop Hypertension (DASH) diet"
(Spec. ,r 1). Claims 1, 13, and 30 are representative and reproduced below:
1. A method for treating essential hypertension in a
patient in need thereof comprising administering to the patient
an effective amount of a dietary supplement consisting
essentially of a potassium-magnesium citrate preparation.
(Br. 8.)
(Id.)
13. A method for ameliorating or correcting one or more
metabolic disturbances in a patient having one or more
metabolic disturbances and essential hypertension, wherein the
one or more metabolic disturbances are selected from the group
consisting of: salt retention, insulin resistance, unusually acid
urine, low serum magnesium, or renal hypercalciuria, the
method comprising providing to the patient a composition
comprising a pharmaceutically effective amount of potassium,
magnesium, and citrate.
30. The method of claim 13, wherein the metabolic
disturbance is insulin resistance.
(Id. at9.)
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Appeal2017-009636
Application 11/673,497
The claims stand rejected as follows:
Claims 1, 3-6, 19-21, 23-25, and 27 stand rejected under 35 U.S.C.
§ I03(a) as unpatentable over the combination of Morris, 3 Szelenyi, 4
Derrien, 5 and W alsdorf. 6
Claims 13-17, 30, and 32 stand rejected under 35 U.S.C. § I03(a) as
unpatentable over the combination of Morris, Szelenyi, Derrien, Walsdorf,
and F errannini. 7
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
ANALYSIS
The combination of Morris, Szelenyi, Derrien, and Walsdorf
Examiner finds that "Morris discloses the treatment of hypertension
using non-halide potassium salts, particularly potassium citrate, and teaches
the use of compositions which have an alkalinizing effect" (Ans. 3--4).
Specifically, Examiner finds that "Morris teaches the need for 'an effective
method for treating essential hypertension which utilizes a potassium
compound[']" and discloses that Morris' "[']invention fulfills these and
3 Morris, Jr. et al., US 5,804,204, issued Sept. 8, 1998.
4 Szelenyi et al., Effect of magnesium orotate and orotic acid on
experimental hypertension and cardiopathogenic changes in heart muscle,"
21 Deutsches Medizinisches Journal 1405-1412 (1970) (Examiner relied
upon CAPLUS, Abstract, Accession Number: 1971:74795, CAN 74:74795
(2014)).
5 Derrien et al., US 2004/0224076 Al, published Nov. 11, 2004.
6 Walsdorfetal., US 5,219,889, issued June 15, 1993.
7 Ferrannini et al., Insulin Resistance in Essential Hypertension, 317 N. Engl.
J. Med. 350-357 (1987).
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Application 11/673,497
other related needs'" (id. at 17; see Morris 3: 4--11). In addition, Examiner
finds that "Morris discloses a working embodiment directed towards the
treatment of subjects afflicted with essential hypertension, using a non-
halide salt of potassium to lower blood pressure ([Morris,] Example 1,
column 7)" (Ans. 17; see Morris 7: 5-8 ("Studies were performed in two
men (ages 55 and 57) with essential hypertension to demonstrate that a non-
halide salt of potassium, potassium bicarbonate, lowered blood pressure")).
For the foregoing reasons, we are not persuaded by Appellant's
contention that Examiner improperly relied upon inherency to establish that
"essential hypertension-is 'necessarily present' in the cited references" (Br.
4; cf Ans. 16 ("Appellant's arguments are misplaced, and are an incorrect
interpretation of[] Examiner's position")).
Examiner finds that "Morris is silent with regard[] to magnesium
citrate" and relies on Szelenyi, Derrien, and Walsdorf to make up for this
deficiency in Morris (see Ans. 4---6). We find no error in Examiner's prima
facie case of obviousness (see id. at 3-7). In this regard, we note that
Appellant does not contest Examiner's combination of Morris with Szelenyi,
Derrien, and Walsdorf (see Br. 3--4 ).
The combination of Morris, Szelenyi, Derrien, Walsdorf, and Ferrannini:
Examiner relies on the combination of Morris, Szelenyi, Derrien,
and W alsdorf to suggest the administration of a single formulation of
magnesium, potassium, and citrate to treat essential hypertension (see Ans.
9-12). Examiner finds, however, that the combination of Morris, Szelenyi,
Derrien, and W alsdorf fails to disclose "metabo lie disturbances that []
accompany essential hypertension" (id. at 12). Examiner, therefore, relies
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Application 11/673,497
on Ferrannini to disclose, inter alia, that "essential hypertension is itself an
insulin-resistant state" (id. at 13; see Ferrannini, Abstract; see generally
Ferrannini 354 ("essential hypertension may be an insulin-resistant state in
itself').
Thus, based on the combination of Morris, Szelenyi, Derrien,
Walsdorf, and Ferrannini, Examiner concludes that, at the time Appellant's
invention was made, it would have been "prima facie obvious to administer
potassium, magnesium, and citrate to a patient afflicted with hypertension
who is also afflicted with insulin resistance, as the administration of
potassium, magnesium, and citrate to a patient afflicted with hypertension is
obvious, regardless of whether that patient also has insulin resistance" (Ans.
14 ( emphasis omitted)). In this regard, Examiner reasons that
one having ordinary skill in the art would have a reasonable
expectation of success in using the composition disclosed by
W alsdorf in the methods for treating hypertension, as taught by
Morris, Derrien, and Szelenyi, and one would further recognize
that treating hypertension in a subject would also provide a
therapeutic benefit for insulin resistance in the subject.
(Id. (emphasis added)) We are not persuaded.
Appellant's independent claim 13, from which claims 14--17, 30, and
32 depend, is directed to a method of ameliorating or correcting one or more
metabolic disturbances in a patient having one or more specifically recited
metabolic disturbances, such as insulin resistance, and essential hypertension
(see Br. 8). Although, Examiner asserts that the administration of a
composition, suggested by the combination of prior art relied upon by
Examiner, to an individual experiencing essential hypertension may provide
some therapeutic benefit with regard to insulin resistance, Examiner failed to
establish that such a composition would necessarily be effective in
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Application 11/673,497
ameliorating or correcting the metabolic disturbance, i.e., insulin resistance,
as is required by Appellant's claimed invention (see Ans. 14; cf Br. 8; see
Br. 5 ("none of the cited references suggest amelioration or correction of
[the claimed] metabolic disturbances")).
We recognize Examiner's reliance on Ferrannini to teach that insulin
resistance is "directly correlated with the severity of hypertension" and
conclusion, from this teaching, that "[t]he ordinarily skilled artisan would
reasonably expect that the treatment of hypertension would also have a
therapeutic effect on insulin resistance" (Final Act. 6). We acknowledge
Ferannini's teaching of a correlation between insulin resistance and
hypertension. Ferannini, however, ultimately leaves open the question of
whether hypertension causes insulin resistance (see Ferrannini 355 ("The
obvious question that the present studies present is whether there is a causal
relation between hypertension and insulin resistance"). Accordingly, the
record does not provide a persuasive basis on which to conclude that the
skilled artisan would reasonably have expected that a composition taught to
treat essential hypertension would also be effective in the amelioration or
correction of insulin resistance as required by Appellant's claimed invention.
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to Appellant's claim 1. The
rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Morris, Szelenyi, Derrien, and Walsdorf is affirmed. Claims
3-6, 19-21, 23-25, and 27 are not separately argued and fall together with
Appellant's claim 1.
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Application 11/673,497
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to Appellant's claims 13-
17, 30, and 32. The rejection of claims 13-17, 30, and 32 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Morris, Szelenyi, Derrien,
W alsdorf, and F errannini is reversed.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a).
AFFIRMED-IN-PART
7