Ex Parte Rau

Patent Trial and Appeal Board

Aug 15, 2014

11226415 (P.T.A.B. Aug. 15, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/226,415 09/15/2005 Allen H. Rau PHYZ-0013-UT1 6734
80308 7590 08/15/2014
Steven B. Kelber
HC Park & Associates, PLC
1894 Preston White Drive
Reston, VA 20191
EXAMINER
AHMED, HASAN SYED
ART UNIT PAPER NUMBER
1615
MAIL DATE DELIVERY MODE
08/15/2014 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ALLEN H. RAU
____________

Appeal 2012-010503
Application1 11/226,415
Technology Center 1600
____________

Before DONALD E. ADAMS, ULRIKE W. JENKS, and
CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to
an effervescent composition comprising: carbohydrate, sodium, and chloride
having an osmolality of less than 310 mOsm/kg when diluted in solution.
The Examiner has rejected the claims for obviousness and on the grounds of
non-statutory obviousness type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.

1 Appellant identifies Tower Laboratories, Ltd., the as the Real Party in
Interest. (App. Br. 2.)
Appeal 2012-010503
Application 11/226,415

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STATEMENT OF THE CASE
Claims 1, 3-7, 11, 12, 15-19, 26, and 27 are on appeal, and can be
found in the Claims Appendix of the Appeal Brief. Claim 1 is representative
of the claims on appeal, and reads as follows:
1. An effervescent tablet, powder or granule comprising: an
edible acid; a carbonate salt; and a carbohydrate; wherein said
effervescent tablet, powder or granule, when diluted in an
appropriate amount of water, yields a solution with an
osmolality of less than 310 mOsm/kg in which the sodium and
chloride content do not exceed 52 and 40 mmol/liter
respectively, and wherein the levels of carbohydrate are above
50 mmol/liter.
The following grounds of rejection are before us for review:
I. claims 1, 3-5, 11, 12, 19, 26, and 27 under 35 U.S.C. § 103(a)
over King2 in view Greenleaf;3
II. claims 6 and 7 under 35 U.S.C. § 103(a) over King in view
Greenleaf and further in view of Simone;4
III. claims 15-18 under 35 U.S.C. § 103(a) over King in view
Greenleaf and further in view of Thomas;5 and
IV. claims 1-7, 11, 12, 15-19, 26, and 27 on the ground of
nonstatutory obviousness-type double patenting as being
unpatentable over claims 1-11 of copending Application No.
11/234,312 (’312 application) in view of King, further in view
of Simone, further in view of Thomas.

2 King et al., US 2003/0134804 Al, published July 17, 2003.
3 Greenleaf, US 5,447,730, issued Sept. 5, 1995.
4 Simone, US 5,397,786, issued Mar. 14, 1995.
5 Thomas et al., US 6,329,414 B1, issued Dec. 11, 2001.
Appeal 2012-010503
Application 11/226,415

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I.-III. The Issue: Obviousness over King and Greenleaf
The Examiner finds that “King teaches a rehydration formulation . . .
which may be formulated as an effervescent powder.” (Ans. 3.) The
Examiner acknowledges that King does not teach a particular formulation
falling within the limitation of claim 1 (id.at 4). The Examiner finds that
King’s formulation for combating dehydration can include an edible acid
(citric acid), a carbonate salt (sodium bicarbonate), and a carbohydrate
(glucose) (id.). In addition, King also provides overlapping ranges for the
solutions claimed “sodium content of 25 to 100 mM, . . . chloride content of
10 to 100 mM . . . and a carbohydrate content of 25 to 135 mM” (id.). The
Examiner acknowledges that King does not teach formulating the
composition to have an “osmolality of less than 310 mOsm/kg” (id. at 5).
The Examiner looks to Greenleaf to supply this limitation. Specifically, the
Examiner finds that Greenleaf “teaches a rehydration beverage for rapid
restoration of hydration homeostasis (see abstract). The disclosed beverage
has an osmolality of 270 mOsm/kg . . . . Greenleaf explains that the
disclosed osmolality results in optimal fluid absorption” (id. at 5).
The issue is: Does the preponderance of the evidence of record
support the Examiner’s conclusion that the combination of references
renders the claims obvious?

Findings of Fact
FF 1. King disclosed a rehydration formulation comprising chloride.
[T]he concentration of chloride ion in the aqueous formulation
may be in the range 10 to 100 mM, preferably 30 to 90 mM,
more preferably 40 to 85 mM, especially preferably 45 to 80
mM. For combatting dehyration as a symptom of severe
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diarrhoea, higher chloride concentrations are preferred (e.g., 70-
80 mM such as about 80 mM).
(King 2-3: ¶ 38.)
FF 2. King disclosed a rehydration formulation comprising sodium.
The concentration of sodium ions may be adapted to
facilitate sodium co-transport and replacement of electrolyte
loss. In a preferred embodiment, the concentration of sodium
ions in the aqueous formulation is in the range 25 to 100 mM,
preferably 30 to 90 mM, particularly preferably 35 to 90 mM,
more preferably 45 to 90 mM, yet more preferably 60 to 90
mM. For combatting dehydration as a symptom of severe
diarrhoea (e.g., caused by enterotoxin effects), higher sodium
concentrations are preferred (eg 80-90 mM such as about 90
mM). For combatting dehydration as a symptom of less severe
diarrhoea (e.g., caused by viral effects or when hypernatraemia
is a risk), lower sodium concentrations are preferred.
(King 2: ¶ 24.)
FF 3. Greenleaf disclosed rehydration beverage having an optimal
fluid absorption.
It has been found that such hypohydration beverage
performed best when approximately one-half of the sodium
chloride is substituted with sodium citrate in combination with
an artificial sweetener to provide a good tasting beverage. . . .
The components of beverage IV, per 2000 ml total volume, are
9 g of sodium chloride, 15.44 g of sodium citrate and 0.72 g of
aspartame. This beverage, containing only 0.36% sodium ions,
however, has an osmolality of 270 mOsmol/kg, which is very
close to the optimal fluid absorption osmolality of about 285
mOsmol/kg.
(Greeenleaf col. 4, ll. 23-36.)
FF 4. Greenleaf disclosed that “the most preferred osmolality of the
drink for restoring hydration homeostasis is between 285-300 mOsmol/kg.”
(Greeenleaf col. 10, ll. 29-32.)
Appeal 2012-010503
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Principle of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted).
Even post-KSR, “[o]bviousness requires more than a mere showing
that the prior art includes separate references covering each separate
limitation in a claim under examination.” Unigene Labs., Inc. v. Apotex,
Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011). “In determining whether
obviousness is established by combining the teachings of the prior art, the
test is what the combined teachings of the references would have suggested
to those of ordinary skill in the art.” In re GPAC Inc., 57 F.3d 1573, 1581
(Fed. Cir. 1995) (internal quotations omitted).

Analysis
There are three obviousness rejections and all are premised on the
teachings of King and Greenleaf, so we will discuss them together.
The Examiner’s position is that the combination of King and
Greenleaf renders the claims obvious because King discloses rehydration
formulations comprising an edible acid, carbonate salt, and a carbohydrate
(Ans. 3-5; see also FF1 & 2.) The Examiner concludes that
Adjusting the osmolality of the composition is a matter of
routine optimization for a person of ordinary skill in the art.
The Greenleaf reference, as indicated previously, provides
motivation for having an osmolality below 310 mOsm/kg, since
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it states that an osmolality of 270 mOsm/kg results in optimal
fluid absorption (see Greenleaf, col. 4, lines 16-17). Greenleaf
further states that, “... the most preferred osmolality of the drink
for restoring hydration homeostasis is between 285-300
mOsmol/kg.”
(Ans. 10; see also FF3 & 4.)
Appellant contends that “[o]ne cannot simply dilute the solution until
a desired osmolality value is obtained, as the minimum values for sodium
and chloride must be met. . . . [Furthermore,] King not only specifically
observes the importance of such minimums, but teaches one of skill in the
art to keep them considerably higher.” (App. Br. 19.) Appellant
acknowledges that although “osmolality is relatively simple to measure
given the proper instrument, it is extremely difficult to predict.” (Rau6 Dec.
4: ¶ 7.) Appellant provides a Declaration showing a sample solution, based
on King’s formula G that has been modified in accordance with the
teachings of King to provide an effervescent product when placed in 250 ml
of water (Id. at Dec. 6: ¶ 9). The Declaration states that an equal amount of
glucose was substituted for the galactose in King’s formula G, but
“substituting glucose for galactose should not significantly impact
osmolality in the amounts used as galactose is simply a stereoisomer of
glucose” (id. at 6 n.1). This solution was measured for osmolality and found
to be “well in excess” of the 310 mOsmol/kg as required by the claim (id. at
Dec. 6: ¶ 10). Appellant, however, does not identify the exact osmolality for
the solution tested.

6 Declaration of Allen Rau, signed July 10, 2010.
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In rebuttal the Examiner finds that “King’s teachings are much
broader than the particular amounts and ingredients selected by affiant.”
(Ans. 10.) The Examiner finds that claim 1
states that “an appropriate amount of water” is to be added to
the composition to arrive at the claimed osmolality. Adjusting
the osmolality of the composition is a matter of routine
optimization for a person of ordinary skill in the art. The
Greenleaf reference, as indicated previously, provides
motivation for having an osmolality below 310 mOsm/kg, since
it states that an osmolality of 270 mOsm/kg results in optimal
fluid absorption. . . . Greenleaf further states that, “... the most
preferred osmolality of the drink for restoring hydration
homeostasis is between 285-300 mOsmol/kg.”
(Id.)
We agree with the Examiner that King’s general teachings are broad,
and that the claims allow for adjusting the volume of water to an
“appropriate amount” in order to reach the claimed osmolality. Even
though, one of skill in the art may be able to lower the osmolality of a
solution with an appropriate amount of water, the Examiner has not
explained how to predictably maintain the minimum carbohydrate
concentration in this process. A rejection for obviousness, must include
“articulated reasoning with some rational underpinning to support the legal
conclusion.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007),
quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
Here, based on the teaching of Greenleaf, the Examiner at most
identifies a goal to keep osmolality levels to between 285-300 mOsmol/kg in
order to achieve optimal fluid absorption (FF3-4). However, the Examiner
does not provide sufficient evidence-based technical reasoning to support his
position that the ordinary artisan armed with the knowledge of the optimal
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osmolality for a rehydration composition as provided by Greenleaf, could
readily manipulate the composition disclosed by King to arrive at an
effervescent composition with the claimed osmolality level. The mere
“‘knowledge of the goal does not render its achievement obvious,’ and
obviousness generally requires that a skilled artisan have reasonably
expected success in achieving that goal.” Institut Pasteur & Universite
Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1346 (Fed. Cir. 2013)
(citations omitted). Appellant, on the other hand, has provided evidence that
reformulating King’s formula G to be an effervescent composition given the
teaching of King would exceed the claimed osmolality requirement (see Rau
Dec. ¶¶ 8-10; see also App. Br. 12-13; Reply Br. 3.). Based on the totality
of the record, we find that the preponderance of the evidence fails to support
the Examiner’s conclusion that the claimed composition is obvious. In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
We also recognize, but are not persuaded by, the Examiner’s
arguments with respect to the Rau’s Declaration. Specifically, the Examiner
highlights that “[t]he substitution of glucose for galactose in the Rau
declaration test formulation means that twice as much glucose was used in
the Rau declaration test formulation than in Example G of King.” (Ans. 15.)
As explained by Appellant, “an equal amount of glucose was substituted for
galactose. As galactose and glucose are stereoisomers of each other,
substituting glucose for galactose should have no impact on osmolality.”
(Reply Br. 3.) Thus, in the absence of evidence to the contrary, we agree
with Appellant that substituting glucose for galactose should have no effect
on the osmolality of the composition tested in the Rau declaration.
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The Examiner further intimates that based on King one of ordinary
skill in the art would have substituted “maltodextrin or higher
oligosaccharide” in place of glucose in order to reduce the osmolality of the
solution (Ans. 15). As explained by Appellant, “the basis for the theory that
one-sixth of the molar concentration of maltodextrin (six chains) is
somehow the equivalent of one of glucose (King, 0032] [sic] is not apparent,
this will nonetheless give an increased osmolality value” (Rau Dec. 6, ¶ 10).
Here, the Examiner has provided no explanation or any other evidentiary
basis that would have contradicted Appellant’s assertion that using a larger
oligosaccharide albeit at a lower molar concentration would not have the
desired effect of lowering the osmolality of the solution.
We conclude that the preponderance of the evidence of record does
not support the Examiner’s conclusion that the combination of King and
Greenleaf discloses an effervescent composition having all limitations of
independent claim 1 and dependent claims thereto. We thus reverse the
rejections under 35 U.S.C. § 103(a) that rely on the teachings of King and
Greenleaf.

IV. The Issue: Non-Statutory Obviousness Type Double Patenting
Appellant concedes that claims of the ’312 application include a
requirement that the solution is at or below 310 mOsm/kg (App. Br. 20).
However, the claims are silent with regard to “a minimum carbohydrate
value, a minimum sodium value or a maximum chloride value” (id.).
Although, King, Simone, or Thomas each teach that sodium and chloride
must be controlled within certain limits, “each secondary reference [also]
requires high amounts of carbohydrates that will boost osmolality” (id.).
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What is missing from the Examiner’s analysis is an explanation “how one of
skill in the art would proceed from the composition of the ‘312 claims to the
current claims” (id.).
We find that Appellant has the better position. Here, the Examiner
does not cite any evidence or provide any evidence-based technical
reasoning to support his position that the combination of the teachings in
King, Simone, or Thomas when taken in light of the requirement that the
osmolality of the solution in the ’312 application is 310 mOsm/kg would
allow the artisan to arrive at the claimed effervescent product. Here,
Appellant has provided evidence that simply reformulating King’s formula
G to be an effervescent composition given the teaching of King would
exceed the claimed osmolality requirement (see Rau Dec. ¶¶ 8-10; see also
App. Br. 12-13; Reply Br. 3.). Based on the totality of the record, we find
that the preponderance of the evidence fails to support the Examiner’s
conclusion that the claimed composition is obvious over claims 1-11 of
copending application ’312 in view of King, further in view of Simone,
further in view of Thomas.

SUMMARY
We reverse the rejection of claims 1, 3-5, 11, 12, 19, 26, and 27 under
35 U.S.C. § 103(a) over King in view Greenleaf.
We reverse the rejection of claims 6 and 7 under 35 U.S.C. § 103(a)
over King in view Greenleaf and further in view of Simone.
We reverse the rejection of claims 15-18 under 35 U.S.C. § 103(a)
over King in view Greenleaf and further in view of Thomas.
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We reverse the provisional rejection of claims 1-7, 11, 12, 15-19, 26,
and 27 on the ground of nonstatutory obviousness-type double patenting as
being unpatentable over claims 1-11 of copending Application No.
11/234,312 in view of King, further in view of Simone, further in view of
Thomas.
REVERSED

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