Ex Parte Wolf

Board of Patent Appeals and Interferences

Mar 9, 2011

10157644 (B.P.A.I. Mar. 9, 2011)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte BRYAN W. WOLF
__________

Appeal 2010-011332
Application 10/157,644
Technology Center 1600
__________

Before TONI R. SCHEINER, ERIC GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL1
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1-3, 5, 7-9, 11, 13-15, and 17. We have
jurisdiction under 35 U.S.C. § 6(b).

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
Claim 1 is representative of the claims on appeal, and reads as
follows:
1. A method for blunting the postprandial glycemic response to a
meal, said method comprising feeding a diabetic 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.

Independent claims 7 and 13 are drawn to the same method, except
that the preamble of claim 7 recites “[a] method for modulating blood
glucose,” and the preamble of claim 13 recites “[a] method for assisting a
diabetic patient with managing their blood glucose levels.”

The following grounds of rejection are before us for review:
I. Claims 1-3, 5, 7-9, 11, 13-15, and 17 stand rejected under 35
U.S.C. § 103(a) as being rendered obvious by the combination of
Van de Ven2 and Gerrits.3

2 Van de Ven et al., Effects of Liquid Preloads with Different Fructose/Fibre
Concentrations on Subsequent Food Intake and Ratings of Hunger in
Women, 23 APPETITE 139-146 (1994).
3 Peter M. Gerrits and Eva Tsalikian, Diabetes and fructose metabolism, 58
AM J CLIN. NUTR. 796S-799S (1993).
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II. Claims 1-3, 5, 7-9, 11, 13-15, and 17 stand rejected under 35
U.S.C. § 103(a) as being rendered obvious by the combination of
Araya,4 Rodin,5 and Gerrits as evidenced by Matthews.6
III. Claims 1-3, 5, 7-9, 11, 13-15, and 17 stand rejected under 35
U.S.C. § 103(a) as being rendered obvious by the combination of
Araya, Tremble,7 and Gerrits as evidenced by Matthews.
We reverse.

PRINCIPLES OF LAW
As to the interpretation of whether the preamble of a claim provides a
patentable limitation, the Court of Appeals for the Federal Circuit, our
reviewing court, has stated:
If the claim preamble, when read in the context of the entire
claim, recites limitations of the claim, or, if the claim preamble
is “necessary to give life, meaning, and vitality” to the claim,
then the claim preamble should be construed as if in the balance
of the claim. . . . If, however, the body of the claim fully and
intrinsically sets forth the complete invention, including all of
its limitations, and the preamble offers no distinct definition of

4 Araya et al., Effect of protein and carbohydrate preloads on food and
energy intakes in preschool children with different nutritional status, 45
ARCH. LATINOAM NUTR. 25-30 (1995).
5 Judith Rodin, Comparative effects of fructose, aspartame, glucose, and
water preloads on calorie and macronutrient intake, 51 AM J CLIN. NUTR.
428-435 (1990).
6 Matthews et al., Sugar Content of Selected Foods: Individual and Total
Sugars, Home Economics Report, No. 48, 1-2,17-19 (1987).
7 J. M. Tremble and D. Donaldson, Is continued weight gain inevitable in
type 2 diabetes mellitus? 119 THE JOURNAL OF THE ROYAL SOCIETY FOR THE
PROMOTION OF HEALTH 235-239 (1999).
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any of the claimed invention’s limitations, but rather merely
states, for example, the purpose or 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.

Pitney Bowes, Inc. v. Hewlett Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999).
As the Supreme Court pointed out in KSR Int’ l Co. v. Teleflex
Inc., 550 U.S. 398, 418 (2007), “a patent composed of several elements is
not proved obvious merely by demonstrating that each of its elements was,
independently, known in the prior art.” Rather, the Court stated:
[I]t can be important to identify a reason that would have
prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention
does . . . because inventions in most, if not all, instances rely
upon building blocks long since uncovered, and claimed
discoveries almost of necessity will be combinations of what, in
some sense, is already known.

Id. at 418-419 (emphasis added); see also id. at 418 (requiring a
determination of “whether there was an apparent reason to combine the
known elements in the fashion claimed by the patent at issue”) (emphasis
added).
While holding that some rationale must be supplied for a conclusion
of obviousness, the Supreme Court nonetheless rejected a “rigid approach”
to the obviousness question, and instead emphasized that “[t]hroughout this
Court’s engagement with the question of obviousness, our cases have set
forth an expansive and flexible approach . . . .” Id. at 415. The Court also
rejected the use of “rigid and mandatory formulas” as being “incompatible
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with our precedents.” Id. at 419; see also id. at 421 (“Rigid preventative
rules that deny factfinders recourse to common sense, however, are neither
necessary under our case law nor consistent with it.”).
The Court thus reasoned that the analysis under 35 U.S.C. § 103 “need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” Id. at 418; see
also id. at 421.
Finally, the burden of demonstrating unexpected results rests on the
party asserting them. In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972).
Moreover, a showing of unexpected results must be commensurate in scope
with the breadth of the claims. In re Grasselli, 713 F.2d 731, 743 (Fed. Cir.
1983); see also In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978)
(“[O]bjective evidence of non-obviousnesss must be commensurate in scope
with the claims).
`
ISSUE (REJECTION I)
Has the Examiner established by a preponderance of the evidence that
the combination of Van de Ven and Gerrits renders obvious the claimed
methods?

FINDINGS OF FACT
FF1 According to the Specification, “[t]he present invention relates to a
method for reducing the postprandial glycemic excursion to carbohydrates
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by feeding supplemental fructose prior to the carbohydrate challenge” (Spec.
4).
FF2 The Specification teaches further that the “source of fructose may be
any food grade fructose source such as sucrose, maltitol, high fructose corn
syrup, honey, fruit, fruit juice, liquid fructose, powder fructose and
crystalline fructose” (id.).
FF3 In Example 1, 31 healthy nondiabetic volunteers were studied (id. at
11). The Specification discloses:
Fasting plasma glucose concentration (measured at -60
min) was not different (P > 0.05) among the treatments. Peak
incremental change from baseline and incremental area under
the curve for plasma glucose were lower (P < 0.05) when
subjects consumed 10 g fructose 60 or 30 min before the meal
tolerance test compared to when subjects consumed fructose
with the meal or when subjects did not consume any
supplemental fructose. Time to peak glucose did not differ (P >
0.05) between treatments. (Table 3).
(Id.)
FF4 The Examiner’s statement of the rejection over the combination of
Van de Ven and Gerrits may be found at pages 3-5 of the Answer.
FF5 The Examiner finds that Van de Ven teaches “administering liquid
preloads comprising different concentrations of fructose and fiber 30 or 60
minutes before a meal to reduce food intake and aid in weight control” (Ans.
4).
FF6 Specifically, Van de Ven teaches:
Although, compared to the placebo, the subjects ate
significantly less after the most concentrated fructose and fibre
in the experiment with the interval of 30 min before lunch and
seemed to eat less after each of the fructose-fibre preloads in
the experiment with the preload-lunch interval of 60 min,
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energy intake from preload and meal was larger than that from
placebo and meal.

(Van de Ven, p. 144.)
FF7 The Examiner notes that Van de Ven does not administer the preload
to patients with diabetes (Ans. 4).
FF8 The Examiner relies on Gerrits for teaching that “fructose elicits a
lower glucose and insulin response in healthy individuals and in individuals
with diabetes,” and that “fructose in the diets of patients with diabetes has a
definite advantage” (id.).
FF9 The Examiner concludes that it would have been obvious to the
ordinary artisan to administer the preloads of fructose taught to Van de Ven
to diabetic patients because Gerrits teaches that fructose elicits a lower
glucose and insulin response in healthy individuals as well as in individuals
with diabetes (id. at 4-5).

ANALYSIS
Appellant argues that Van de Ven does not support administering
fructose to diabetic individuals before a meal, because although Van de Ven
teaches that the combination of fructose and fiber controlled hunger, the
reference teaches further that it also increased total energy intake, and thus
the reference suggests not administering fructose and fiber before a meal
(App. Br. 4-5).
We agree with Appellant that the Examiner has failed to establish that
the combination of Van de Ven with Gerrits renders the claimed method
obvious. As noted by Appellant, Gerrits teaches that a preload of fructose
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and fiber actually resulted in an increase in energy intake, and thus would
not be useful for the purpose of Van de Ven, which is weight control (Van
de Ven, Abstract). Thus, even though Gerrits teaches that fructose elicits a
lower glucose and insulin response in healthy individuals as well as in
individuals with diabetes, the Examiner has not adequately explained why
the ordinary artisan would administer a fructose and fiber preload as taught
by Van de Ven to a diabetic patient given Van de Ven’s teaching that such
preloads actually resulted in increased energy intake. We are thus
compelled to reverse the rejection.

CONCLUSION OF LAW
We conclude that the Examiner has not established by a
preponderance of the evidence that the combination of Van de Ven and
Gerrits renders obvious the claimed method. We are thus compelled to
reverse the rejection of claims 1-3, 5, 7-9, 11, 13-15, and 17 under 35 U.S.C.
§ 103(a) as being rendered obvious by the combination of Van de Ven and
Gerrits.

ISSUES (REJECTIONS II AND III)
Has Appellant presented evidence of unexpected results, that when
weighed with the evidence of obviousness, is sufficient to support a
conclusion of unobviousness?
FINDINGS OF FACT
FF10 As the art and the issues as to Rejections II and III are essentially the
same, we address the two rejections together.
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FF11 The Examiner’s statement of the rejections predicated on the Araya
reference may be found at pages 5-9 of the rejection.
FF12 We adopt the Examiner’s fact-finding and conclusions as to the prima
facie case as our own.

ANALYSIS
Initially, we conclude that the Examiner has set forth a prima facie
case of obviousness. We thus turn to Appellant’s evidence of unexpected
results.
Citing Table 3 found at page 12 of the Specification, Appellant asserts
that when subjects consumed 10 g of fructose either 30 or 60 minutes before
a meal, the “peak incremental change from baseline and incremental area
under the curve were lower (P<0.05)” (App. Br. 7; see also id. at 8).
The Examiner did not find the data to be commensurate in scope with
the claimed subject matter, as the data is drawn to healthy volunteers, while
the claims require administration of fructose to diabetic patients (Ans. 12-
13). Appellant notes, however, “that one of ordinary skill in the art would
know to routinely extrapolate data from healthy subjects to other
subpopulations that could reasonably be believed to benefit from such data”
(App. Br. 8). As the Examiner has not refuted that statement by evidence or
scientific reasoning, we conclude that Appellant has provided sufficient
evidence of unexpected results to support a conclusion of unobviousness.

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CONCLUSIONS OF LAW
We conclude that Appellant has presented evidence of unexpected
results, that when weighed with the evidence of obviousness, is sufficient to
support a conclusion of unobviousness.
We thus reverse the rejection of claims 1-3, 5, 7-9, 11, 13-15, and 17
under 35 U.S.C. § 103(a) as being rendered obvious by the combination of
Araya, Rodin, and Gerrits as evidenced by Matthews, as well as the rejection
of claims 1-3, 5, 7-9, 11, 13-15, and 17 under 35 U.S.C. § 103(a) as being
rendered obvious by the combination of Araya, Tremble, and Gerrits as
evidenced by Matthews.

REVERSED

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