Ex Parte Wolf

Board of Patent Appeals and Interferences

Sep 28, 2006

10157644 (B.P.A.I. Sep. 28, 2006)

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BRYAN W. WOLF
__________

Appeal No. 2006-2467
Application No. 10/157,644
__________

ON BRIEF
__________

Before SCHEINER, GRIMES, and GREEN, Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the examiner’s
final rejection of claims 1-3, 5, 7-9, 11, 13-15 and 17. Claims 1, 7 and 13 are the
independent claims on appeal, and read as follows:
1. A method for blunting the postprandial glycemic response to
a meal, said method comprising feeding an individual from about 2
grams to about 30 grams of a source of supplemental fructose from
about 10 minutes to about 90 minutes prior to a meal, wherein the
source of supplemental fructose is selected from the group
consisting of liquid fructose, powder fructose and crystalline
fructose, in a dosage form selected from the group consisting of
sachet, tablet, caplet, lozenge, powder, syrup and liquid.

7. A method for modulating blood glucose, said method
comprising feeding an individual from about 2 grams to about 30

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Application No. 10/157,644

grams of a source of supplemental fructose from about 10 minutes
to about 90 minutes prior to a meal, wherein the source of
supplemental fructose is selected from the group consisting of
liquid fructose, powder fructose and crystalline fructose, in a
dosage form selected from the group consisting of sachet, tablet,
caplet, lozenge, powder, syrup and liquid.

13. A method for assisting a diabetic patient with managing their
blood glucose levels, said method comprising feeding said patient
from about 2 grams to about 30 grams of a source of supplemental
fructose from about 10 minutes to about 90 minutes prior to a meal,
wherein the source of supplemental fructose is selected from the
group consisting of liquid fructose, powder fructose and crystalline
fructose, in a dosage form selected from the group consisting of
sachet, tablet, caplet, lozenge, powder, syrup and liquid.

Claims 1-3, 5, 7-9, 11, 13-15 and 17 stand rejected under 35 U.S.C. §
103(a) as being obvious over the combination of Kaufman1 and Anderson.2 In
addition, the claims have been rejected as obvious over the combination of
Lundstrom,3 Moore4 and Anderson. After careful review of the record and
consideration of the issues before us, we reverse the rejections of record.
DISCUSSION
Combination of Kaufman and Anderson
Kaufman is relied upon by the examiner for teaching “a method and
therapeutic food composition to diminish blood sugar fluctuations.” Examiner’s
Answer, page 3. According to the rejection, the composition taught by Kaufman
“is taught to be slowly absorbed in the gastrointestinal tract and maintains

1 Kaufman, U.S. Patent No. 5,843,921, issued December 1, 1998.
2 Anderson et al. (Anderson), “Metabolic Effects of Fructose Supplementation in Diabetic
Individuals,” Diabetes Care, Vol. 12, pp. 337-44 (1989).
3 Lundstrom, The Healing Handbook for Persons with Diabetes, Chapter 5, pp. 1-22 and Chapter
6, pp. 1-27, January 21, 1998, found online at http://www.umassmed.edu/diabeteshandbook/.

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Application No. 10/157,644

relatively stable blood sugar levels . . . for up to six to nine hours,” and is
“administered in place of, or as part of the evening snack or as a daytime snack.”
Id. (emphasis removed). Kaufman is also relied upon for teaching that
“administration depends on patient parameters such as weight, age, and
condition of the patient such as whether the patient takes insulin or other
antidiabetic medications, and the blood sugar profile determined by a finger
stick.” Id. at 4. The examiner notes that “Kaufman [ ] does not specify the instant
time period or the instant form of fructose.” Id.
Anderson is relied upon for teaching the use of fructose supplements in
various forms, such as lemonade-flavored drinks, cookies, or crystalline fructose.
See id. Anderson is also relied upon for teaching that “fructose supplements
improve the glycemic response in diabetic and non-diabetic patients.” Id.
The examiner concludes that it
would have been obvious to one of ordinary skill in the art at the
time the invention was made to administer Kaufman’s food
composition within the instant time frame since Kaufman teaches
that the composition is utilized to maintain the blood sugar level and
administration and amount administered depends on an array of
factors such as weight, age, and the condition of the patient such
as whether the patient takes insulin or other antidiabetic
medications, and the blood sugar profile determined by a finger
stick. For instance, one would have been motivated to consume
Kauffman’s therapeutic composition prior to a meal, if one’s blood
sugar profile was near hypoglycemia (low blood sugar level) and
the time in which the next meal is consumed depends on the blood
sugar level since a meal immediately consumed with the fructose
source may cause hyperglycemia. Therefore, the time frame in

4 Moore et al. (Moore), “Acute Fructose Administration Decreases the Glycemic Response to an
Oral Glucose Tolerance Test in Normal Adults,” The Journal of Clinical Endocrinology &
Metabolism, Vol. 85, pp. 4515-19 (2000).

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which the composition is administered is a manipulatable parameter
that is defined by the patient’s condition, i.e. the blood sugar profile.

Id. at 4-5.
The burden is on the examiner to set forth a prima facie case of
obviousness. See In re Fine, 837 F.2d 1071, 1074, 5 USPQ2d 1596, 1598-99
(Fed. Cir. 1988). “A rejection based on section 103 clearly must rest on a factual
basis, and these facts must be interpreted without hindsight reconstruction of the
invention from the prior art. In making this evaluation, all facts must be
considered. The Patent Office has the initial duty of supplying the factual basis
for its rejection. It may not, because it may doubt that the invention is patentable,
resort to speculation, unfounded assumptions or hindsight reconstruction to
supply deficiencies in its factual basis. To the extent the Patent Office rulings are
so supported, there is no basis for resolving doubts against their correctness.
Likewise, we may not resolve doubts in favor of the Patent Office determination
when there are deficiencies in the record as to the necessary factual bases
supporting its legal conclusion of obviousness.” In re Warner, 379 F.2d 1011,
1017, 154 USPQ 173, 178 (CCPA 1967), cert. denied, 389 U.S. 1057 (1968)
(emphasis in original).

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Appellant argues that “neither Anderson nor Kaufman specifically
discloses fructose administration at any time within the 10-90 minute range to
which the claims on appeal are limited.” Appeal Brief, page 6. We agree, and
the rejection is reversed.
Anderson teaches that 50 to 60 grams of fructose was incorporated into
the diet of fourteen middle-aged men with diabetes. There is no discussion in the
reference of when the fructose supplementation was given to the subjects.
Kaufman, as noted by the rejection, teaches a therapeutic food
composition, while teaching that patients taking insulin may be treated during the
day, see Kaufman, Col. 5, lines 28-30, and teaches that it is preferably
administered to a diabetic patient before bedtime, see id. at Col. 2, lines 39-45.
In addition, the reference teaches that it is slowly metabolized over 6 to 8 hours.
Thus, there is no suggestion in the Kaufman reference, or in the combination,
that the therapeutic food composition should be administered 10 to 90 minutes
before a meal.
Combination of Lundstrom, Moore and Anderson
Lundstrom, which is a handbook to help people deal with diabetes, is
relied upon for teaching “that the well-balanced meal plan for a diabetic is based
on the individual needs, tastes, activity level, and life style and that the meal
times and amount are planned and adjusted for individual needs,” and that “[t]he
diet includes breakfast, lunch, an afternoon snack of one fruit, dinner, and an
evening snack of one starch, milk, and one fruit.” Examiner’s Answer, page 6.
According to the examiner, fruits such as apples, bananas and fruit cocktails

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contain 10.5, 3.1 and 17 grams of fructose, respectively, and juices such as
orange juice and apple juice contain 7.4 and 13.9 grams of fructose, respectively.
The examiner notes that Lundstrom “does not specify the instant time period,”
“the inherent mechanism in which fructose works,” and “the instant form of
fructose.” Id. at 7.
Moore teaches the administration of glucose with or without 7.5 grams of
fructose, with blood samples being drawn every 15 to 120 minutes. See id.
Moore is also relied upon for teaching that their findings “hold promise for the
improvement of carbohydrate tolerance in individuals with impaired glucose
tolerance and diabetes.” See id.
Anderson is relied upon as in the previous rejection. See id.
The examiner again concludes:
It would have been obvious to one of ordinary skill in the art
at the time the invention was made to manipulate when the fructose
snack, i.e. fruit or fruit juice, is administered since Lundstrom
teaches that the purpose of a well-balanced meal is to maintain the
blood sugar level and it depends on an array of factors based on
the individual. Lundstrom further teaches these factors that are
known to a skilled artisan consist of an individual’s weight, age, and
condition of the patient such as whether the patient takes insulin or
other antidiabetic medications, and the blood sugar profile
determined by a finger stick. For instance, one would have been
motivated to consume Kauffman’s [sic] therapeutic composition
prior to a meal, if one’s sugar profile was near hypoglycemia (low
blood sugar level) and the time in which the next meal is consumed
depends on the blood sugar level. It is obvious that a meal would
not be immediately consumed with the

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Application No. 10/157,644

fructose snack since it may cause hyperglycemia. Therefore, the
time frame in which the composition is administered is a
manipulatable parameter that is defined by the patient’s condition,
i.e. the blood sugar profile.

Id. at 4-5.
Again appellants argue that “[n]one of the references disclose the
administration of fructose from 10-90 minutes before a meal or snack.” Appeal
Brief, page 7. We agree, and the rejection is reversed.
Moore looks at plasma glucose concentrations after administration of
glucose or glucose supplemented with fructose, wherein blood samples were
obtained twice before and every 15 minutes after administration, for a period of
two hours. Thus, there is no discussion in either Anderson or Moore of when the
fructose supplementation was given to the subjects relative to a meal or snack.
Lundstrom merely teaches an afternoon snack, given between lunch and
dinner, of a piece of fruit. See id. at 26. There is no discussion of the timing of
lunch, the afternoon snack, and dinner. Thus, again, there is no suggestion in
the Lundstrom reference, or in the combination, that a fructose supplement
should be administered 10 to 90 minutes before a meal.
OTHER ISSUES
The examiner should consider the patentability of the claims in view of the
Van de Ven5 reference, the abstract of which accompanies this opinion. In that

5 Van de Ven et al., “Effects of liquid preloads with different fructose/fibre concentrations on
subsequent food intake and ratings of hunger in women,” Appetite, Vol. 23, No. 2, pp. 139-46
(1994) (abstract only).

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regard, we suggest that the examiner obtain the entire reference, as “[c]itation of
and reliance upon an abstract is generally inappropriate where both the abstract
and the underlying document are prior art.” MPEP §706.02 (II) (8th edition,
Revision 2, May 2004). Moreover, in order for meaningful appellate review to
occur, the examiner must present a full and reasoned explanation of the rejection
see, e.g., In re Lee, 277 F.3d 1338, 1342, 61 USPQ2d 1430, 1432 (Fed. Cir.
2002), and that would include analysis of the full underlying document.
The Van de Ven reference teaches looks at the effects of preloads of
fructose administered 30 or 60 minutes before lunch on food intake and ratings of
hunger in women. Note that the recitation of “[a] method for blunting the
postprandial glycemic response to a meal” in claim 1 is a statement of intended
use, and not a patentable limitation, as the body of the claim sets forth the
complete invention. See Pitney Bowes, Inc. v. Hewlett Packard Co., 182 F.2d
1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999) (“If . . . the body of the
claim fully and intrinsically sets forth the complete invention, including all of the
limitations, and the preamble offers no distinct definition of the claimed
invention’s limitations, but merely states, for example, the purpose of the
intended use of the invention, then the preamble is of no significance to claim
construction because it cannot be said to constitute or explain a claim
limitation.”). All that is therefore required by each of the independent claims is

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“feeding an individual from about 2 grams to about 30 grams of a source of
supplemental fructose from about 10 minutes to about 90 minutes prior to a
meal, wherein the source of supplemental fructose is selected from the group
consisting of liquid fructose, powder fructose and crystalline fructose, in a dosage
form selected from the group consisting of sachet, tablet, caplet, lozenge,
powder, syrup and liquid.” Thus, the Van de Ven reference appears to anticipate
the method recited in the independent claims.

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Application No. 10/157,644

CONCLUSION
Because the examiner failed to set forth a prima facie case of
obviousness, the rejections of record are reversed. In addition, upon return of
the application, the examiner should consider the patentability of the claims in
view of the Van de Ven reference, as discussed in the “Other Issues” section of
the opinion.
REVERSED

)
Toni R. Scheiner )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Eric Grimes )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
Lora M. Green )
Administrative Patent Judge )

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