Ex Parte Frippiat et al

Board of Patent Appeals and Interferences

Apr 26, 2010

10182064 (B.P.A.I. Apr. 26, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ANNE FRIPPIAT, JAN VAN LOO and GEORGES SMITS
__________

Appeal 2009-010881
Application 10/182,064
Technology Center 1600
__________

Decided: April 26, 2010
__________

Before ERIC GRIMES, DONALD E. ADAMS, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an inulin
product. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
STATEMENT OF THE CASE
The Specification discloses that “[i]nulin is a fructan-type
carbohydrate, consisting mostly of fructose units, which occurs in many
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plants as a reserve carbohydrate” (Spec. 1: 13-14). An inulin molecule is
characterized by a “degree of polymerisation (DP)” that depends on the
number of saccharide units in the molecule (id. at 1: 27-29). “Inulin is
further characterised by its (number) average degree of polymerisation,
represented by ( ). This is the value which corresponds to the total
number of saccharide units … in a given inulin sample divided by the total
number of inulin molecules in said sample.” (Id. at 1: 29-32.)
Claims 30-37, 39-42, 51-58, and 60-62 are on appeal. Claims 30 and
51 are representative and read as follows:
30. An inulin product comprising a mixture of an easily fermentable
inulin (EFI) component and a hardly fermentable inulin (HFI) component,
wherein the weight ratio EFI/HFI ranges from 10/90 to 70/30, the EFI
component is free from agave inulin and comprises a short-chain inulin with
a degree of polymerization (DP)<10, the HFI component comprises a long-
chain inulin with a number average degree of polymerization ( )≥20, and
the total content of inulin with (DP)=9 and (DP)=10 is maximally 5% (% is
wt% on total inulin, determined by gas liquid chromatography (GLC)).

51. An inulin product comprising a mixture of an easily fermentable
inulin (EFI) component and a hardly fermentable inulin (HFI) component,
wherein the weight ratio EFI/HFI ranges from 10/90 to 70/30, the EFI
component comprises agave inulin or a mixture of agave inulin with a short-
chain inulin with a (DP)<10, the HFI component comprises a long-chain
inulin with a ( )≥20, and the total amount of inulin with (DP)=9 and
(DP)=10 is maximally 5% (% is wt % on total inulin, determined by GLC).

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The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• claims 30-37 and 39-42 in view of Taper A;1
• claims 51-58 and 60-62 in view of Van Loo;2 and
• claims 30-37 and 39-42 in view of Van Loo and Taper B.3
I.
Issue
The Examiner has rejected claims 30-37 and 39-42 under 35 U.S.C.
§ 103(a) as being obvious in view of Taper A. Claims 31-37 and 39-42 have
not been argued separately and therefore stand or fall with claim 30. 37
C.F.R. § 41.37(c)(1)(vii).
The Examiner finds that Taper A “discloses a pharmaceutical
composition comprising inulin and an anti-metabolic anti-cancer drug.…
Suitable inulins include those having an average DP of greater than or equal
to 23, or of between 2 to 7” (Ans. 4). The Examiner concludes that it
“would have been obvious to one of ordinary skill in the art … to produce a
mixture of high- and low-DP inulins according to Taper…, having a ratio of
10/90 to 70/30 … because Taper et al. already generally discloses [the]
combination of the two recited ingredients” (id. at 5).
Appellants contend that they have submitted a declaration under 37
C.F.R. § 1.131 antedating Taper A (Appeal Br. 10-11), that Taper A does
not suggest a product comprising both oligofructose and inulin or the
claimed EFI/HFI ratio (id. at 12-13; Reply Brief 2-4; Sur-Reply Br. 2-4), and

1 Taper et al., WO 99/59600, Nov. 25, 1999
2 Van Loo et al., WO 98/52578, Nov. 26, 1998
3 Taper et al., Influence of Inulin and Oligofructose on Breast Cancer and
Tumor Growth, 129 J. NUTR. 1488S-1491S (1999).
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that any prima facie case of obviousness has been overcome by a showing of
unexpected results (Reply Br. 5; Sur-Reply Br. 3-6).
The issues with respect to this rejection are:
Does Appellants’ declaration under 37 C.F.R. § 1.131 antedate Taper
A?; if not,
Does Taper A suggest a product having the claimed EFI and HFI
components in the claimed ratio?; and, if so,
Have Appellants provided a showing of unexpected results that
outweighs the evidence supporting prima facie obviousness?
Findings of Fact
1. The instant application has an effective filing date of Feb. 14, 2001
and a priority date of Feb. 15, 2000 (Notice of Acceptance of Application
under 35 U.S.C. § 371 and 37 C.F.R. § 1.494 or 1.495, mailed Dec. 2, 2002).
2. Taper A discloses a composition comprising a “combination of a
non-digestible carbohydrate, i.e. an inulin (including inulin, oligofructose
and mixtures thereof) and an anti-cancer drug” for the treatment of cancer
(Taper A, 7).
3. Taper A discloses that “[i]n a preferred embodiment the inulin is a
chicory inulin with a ( ) of about 10. In another preferred embodiment
the inulin is a chicory inulin with a ( ) of ≥ 23, typically of about 25 to
about 30.” (Id. at 8: 25-27.)
4. Taper A discloses that, “[i]n still another preferred embodiment,
the inulin is an oligofructose, more preferably an oligofructose with a (DP)
of 2 to 7.” (Id. at 8: 27-29.)
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5. Taper A discloses that “[i]n a particularly preferred embodiment
the inulin is chicory inulin or oligofructose or a mixture thereof and the anti-
cancer drug is 5-fluorouracil or methotrexate” (id. at 8: 32-34).
6. The Specification discloses an analysis of the effect of dietary
oligofructose (DP mainly from 2-7), inulin ( =25), or both (at a ratio of
45/55) on calcium absorption in the rat. The Specification states that
“calcium absorption was increased in all test groups, but only the increase of
calcium absorption in group 4 [mixture of oligofructose and inulin] was
found to be statistically significant” compared to rats fed no inulin or
oligofructose (Spec. 22-24).
7. The Specification discloses an analysis of the effect of dietary
oligofructose (DP mainly from 2-7), inulin ( =25), or both (at a ratio of
45/55) on azoxymethane-induced aberrant crypt formation (ACF), a
precursor to cancer, in the rat colon. (Spec. 30-34). The Specification states
that “ACF induction by AOM in the proximal part as well as in the distal
part of the rat colon is reduced by various inulin products … but
significantly better by the inulin product according to the invention” (id. at
33: 13-17).
Principles of Law
“Prior invention may not be established under this section if … [t]he
rejection is based upon a statutory bar.” 37 C.F.R. § 1.131.
“It is not inventive to discover the optimum or workable ranges by
routine experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955).
“It is well established that the objective evidence of nonobviousness
must be commensurate in scope with the claims.” In re Lindner, 457 F.2d
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506, 508 (CCPA 1972). See also id. at 508 (“Here, only one mixture of
ingredients was tested.… The claims, however, are much broader in scope,
… and we have to agree with the Patent Office that there is no ‘adequate
basis for reasonably concluding that the great number and variety of
compositions included by the claims would behave in the same manner as
the [single] tested composition.’”) (bracketed material in original).
Analysis
Claim 30 is directed to an inulin product comprising a mixture of an
easily fermentable inulin (EFI) with a (DP) < 10, and a hardly fermentable
inulin (HFI) with a ( ) ≥20, with the EFI/HFI weight ratio between 10/90
and 70/30. Claim 30 also requires that the total content of inulin with
(DP) = 9 and 10 is no more than 5% based on total inulin.
Taper A discloses a pharmaceutical composition comprising a
combination of inulin and an anti-cancer drug, and discloses that the inulin is
preferably an oligofructose with a (DP) of 2-7 (FF 4) or chicory inulin with a
( ) of either about 10 or ≥ 23 (FF 3), or a mixture of oligofructose and
chicory inulin (FF 5). In view of the express disclosure in Taper A of a
composition comprising a mixture of chicory inulin and oligofructose, it
would have been obvious to one of skill in the art to combine chicory inulin
with a ( ) of ≥ 23 with oligofructose with a (DP) of 2 to 7, because Taper
A discloses that those species are among its preferred forms of inulin.
As an initial matter, Appellants argue that the Van Loo Rule 131
Declaration establishes possession of “the claimed invention before the
November 25, 1999 publication date of the Taper et al. PCT application”
(Appeal Br. 10). Appellants also argue that the instant application “has an
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effective filing date which is the priority date enjoyed by its underlying PCT
Application, namely, February 15, 2000” (id. at 11).
Appellants’ arguments are not persuasive. As recognized by the
Examiner, Taper is prior art under 35 U.S.C. § 102(b) because it was
published more than one year before the effective U.S. filing date (Feb. 14,
2001) of the instant application (Ans. 8-9). Therefore, it cannot be antedated
using a Rule 131 declaration.
Appellants do not dispute that Taper A suggests the claimed EFI
component or the claimed HFI component, or that the combination of Taper
A’s EFI/HFI components would have the required amount of inulin with a
(DP) equal to 9 or 10. Appellants argue that Taper A discloses chicory
inulin (with an average DP of ≥ 23) and oligofructose as two mutually
exclusive embodiments and does not suggest a composition having both
(Appeal Br. 12).
This argument is not persuasive. As set forth above, Taper A
discloses that a preferred inulin embodiment “is chicory inulin or
oligofructose or a mixture thereof.” Thus, Taper A expressly suggests a
mixture of a chicory inulin and an oligofructose.
Appellants also argue that the Examiner erred in finding that Taper A
discloses the claimed EFI/HFI ratio because “only result effective variables
can be optimized” (Reply Br. 2). Appellants argue that “there is no
indication in the prior art that [the] effectiveness of the therapeutic is a
function of the … ratio of EFI to HFI. Recognition of this functionality is
essential to the obviousness of conducting experiments to” optimize the
EFI/HFI ratio (Reply Br. 3).
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This argument is not persuasive. Although Taper A does not disclose
a particular ratio of the oligofructose/inulin, the disclosure that the
components can be used in a mixture to treat cancer, would have suggested
to one of skill in the art that the amounts of the individual components in a
mixture would affect the efficacy of the mixture, and therefore should be
optimized. Claim 30 encompasses a broad range of EFI/HFI ratios,
including a 50/50 mixture, and Appellants have pointed to no evidence that
Taper A’s suggestion of a mixture of oligofructose and chicory inulin would
not have made obvious a mixture encompassed by claim 30.
Appellants also argue that the claimed composition provides
unexpected results (Reply Br. 5). Appellants argue that Table 1 of the
Specification provides evidence that the claimed HFI/EFI inulin
combination provided enhanced intestinal calcium absorption in comparison
to the same amounts of oligofructose or long-chain inulin (Sur-Reply Br. 4).
Appellants also argue that Table 8 of the Specification provides evidence of
improved and unexpected efficacy for the claimed composition in reducing
the number of aberrant crypt foci, putative cancer precursors (id.).
This argument is not persuasive. In accord with In re Lindner,
evidence of nonobviousness must be commensurate in scope with the
claims; i.e., it must provide a reasonable basis for concluding that untested
embodiments encompassed by the claims would behave in the same manner
as tested embodiments. Here, the Specification discloses, at best,
unexpected results based on administration of an EFI/HFI combination at a
ratio of 45/55. Claim 30, however, encompasses mixtures ranging from
10% EFI with 90% HFI to 70% EFI with 30% HFI. The Specification does
not provide a reasonable basis for concluding that the full range of ratios
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encompassed by the claims would provide results similar to those observed
for the 45/55 EFI/HFI mixture. Thus, the evidence of nonobviousness is not
commensurate in scope with the claim.
Conclusion of Law
The Van Loo Declaration under 37 C.F.R. § 1.131 does not antedate
Taper A. Taper A suggests a product having the claimed EFI and HFI
components in the claimed ratio. Appellants have not provided a showing of
unexpected results that outweighs the evidence supporting prima facie
obviousness.
II.
Issue
The Examiner has rejected claims 51-58 and 60-62 under 35 U.S.C.
§ 103(a) as being obvious in view of Van Loo.
The Examiner finds that Van Loo “discloses compositions for the
treatment of or protection from colon cancer …comprising a fructan with an
average degree of polymerization of at least 15,” which can be linear chain
inulins, branched inulins, and mixtures of linear and branched inulins (Ans.
5-6). The Examiner further finds that “the shorter branched inulins of Van
Loo et al. having a DP of 15 or 16 are reasonably considered to be agave
inulin” because the Specification states that “agave inulin is defined as a
branched inulin typically with an average DP of 14-16” (Id. at 6, citing Spec.
11: 6-11.). The Examiner concludes that it “would have been obvious to one
of ordinary skill in the art … to produce a mixture of high-DP inulins and
agave inulins … because Van Loo et al. already generally discloses
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compositions containing inulins having an average DP in a range that
includes agave inulins and long-chain inulins having a DP (25)” (id.).
Appellants contend that Van Loo does not disclose agave inulin or
that agave inulin is an easily fermentable inulin (EFI), and that Appellants’
recognition of agave inulin as an EFI “represents a separate inventive step”
that led to the claimed EFI/HFI combination (Appeal Br. 13-14).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Van Loo would have made obvious a
composition comprising agave inulin and an HFI component with a ( )
≥20?
Additional Findings of Fact
8. The Specification discloses that agave inulin is “a branched inulin,
typically of ( ) of 14 to 16 (id. at 11: 10-11).
9. The Specification discloses that “[a]gave inulin is commercially
available, for example industrial grade agave inulin as GAVEDIET® PR
with a ( ) of 14-16” (id. at 4: 4-7).
10. Van Loo discloses “a fructan with an average degree of
polymerisation of at least 15 for the manufacture of a composition for the
prevention and/or treatment of colon cancer” (Van Loo, abstract).
11. Van Loo discloses that “fructans, in particular inulins, with a
higher average degree of polymerisation, present significantly enhanced
preventive and inhibiting properties against colon cancer…, compared to
fructans with a lower average degree of polymerization” (id. at 6: 9-12).
12. Van Loo discloses that in a
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preferred embodiment, the fructan is inulin, preferably with an
average degree of polymerisation of at least 20, even more
preferably ranging from 20 to 70. In a further preferred
embodiment, the inulin has an average degree of polymerisation
ranging from 20 to 40. A typically preferred inulin has an
average degree of polymerisation about 25.
(Id. at 6: 31-35.)
13. Van Loo discloses that “[t]ypical inulins suitable according to the
present invention are chicory inulins . . . with an average degree of
polymerisation of about 25” (id. at 7: 4-8).
Principles 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).
Analysis
Claim 51 is directed a composition comprising a long-chain inulin and
an easily fermentable inulin (EFI) component that can be agave inulin.
The Examiner reasons the “claims recite ‘agave inulin’ which is a
branched inulin with an average DP of 14-16. The prior art recites branched
inulins with a degree of polymerization that can be as low as 15-16.
Appellant has provided no reason to believe that these inulins are not easily
fermentable” (Ans. 10).
Appellants argue that the claims require a combination of EFI and
HFI components, but Van Loo does not disclose that agave inulin is an
easily fermentable inulin (Appeal Br. 13). Appellants argue that their
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recognition of agave inulin as an EFI “represents a separate inventive step to
be taken starting from Van Loo” (id. at 13-14)
Appellants’ arguments are persuasive that the Examiner has not
adequately explained how Van Loo would have made it obvious to combine
agave inulin with a long-chain inulin. Van Loo discloses that inulin
compositions with a “higher average degree of polymerisation” (FF 11) for
the treatment of or prevention of colon cancer. Van Loo discloses that the
inulin in its compositions can have an average degree of polymerization of at
least 15, preferably at least 20, and typically 25 (FFs 12, 13).
The Specification provides evidence that a person of ordinary skill in
the art would have known of agave inulin with a ( ) of 14-16, because it
is commercially available. A skilled worker reading Van Loo, therefore,
would have understood that agave inulin could be used in Van Loo’s
method, even if it was as the low end of Van Loo’s size range. However, the
Examiner has not pointed to any reason that would have led a skilled worker
to combine agave inulin with a long-chain inulin having a ( ) ≥20, as
required by claim 51. Thus, the rejection of claim 51, and dependent claims
52-58 and 60-62, as being obvious in view of Van Loo is reversed.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that Van Loo would have made obvious a composition comprising agave
inulin and an HFI component with a ( ) ≥20.
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III.
Issue
The Examiner has rejected claims 30-37 and 39-42 under 35 U.S.C.
§ 103(a) as being obvious in view of Van Loo and Taper B. Claims 31-37
and 39-42 have not been argued separately and therefore stand or fall with
claim 30. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner relies on Van Loo as discussed above. The Examiner
finds that Taper B “discloses a study [in rats] of the anticarcinogenic activity
of oligofructose” (Ans. 7). The Examiner concludes that it “would have
been obvious to one of ordinary skill in the art … to produce a mixture of
high- and low- DP inulins according to Van Loo et al. above, having a ratio
of 10/90 to 70/30 … in order to produce a nutritional supplement or
neutraceutical having general anti-cancer activity because both ingredients
are disclosed individually to have activity against different types of cancer”
(id. at 7-8).
Appellants contend that the Examiner erred because Van Loo
discloses colon cancer treatment while Taper B discloses breast cancer
treatment (Appeal Br. 14), and the cited references do not suggest the
claimed EFI/HFI ratio range of 10/90 to 70/30 or a long chain inulin having
an average degree of polymerization of exactly 20 (Reply Br. 6).
The issues with respect to this rejection are: Does the evidence of
record support the Examiner’s conclusions that one of skill in the art would
have considered it obvious to combine the oligofructose taught by Taper B
with the inulin taught by Van Loo, and that the cited references make
obvious the EFI/HFI ratio and the long chain inulin component recited in
claim 30?
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Additional Findings of Fact
14. Taper B discloses that, in a “study on methylnitrosourea-induced
mammary carcinogenesis in Sprague-Dawley female rats … [t]here was a
lower number of tumor-bearing rats and a lower total number of mammary
tumors in oligofructose-fed rats than in the group fed the basal diet alone.”
(Taper B, abstract).
15. Taper B discloses that the
growth of … two different transplantable tumor cell lines is
distinctly inhibited in mice fed a 15% oligofructose-, inulin- or
pectin-supplemented diet. There was practically no difference
in the tumor growth inhibitory effect among all three dietary
nondigestible carbohydrates in the experiments on TLT
[transplanted liver] tumor, but oligofructose appeared to be
slightly more active than inulin or pectin on EMT6 tumor [a
mammary carcinoma]. In both tumors, this inhibitory effect
reached almost 50% compared with mice fed the control diet.
(Id. at 1491S.)
16. Taper B discloses that the prior are reported that “inulin and
oligofructose reduce the incidence of colonic aberrant crypt foci in
azoxymethane treated rats” (id.).
17. Taper B concludes that “[s]uch nontoxic dietary treatment
appears to be easy and risk free for patients, applicable as an adjuvant factor
in the classical protocols of human cancer therapy” (id., abstract).
Principles of Law
“[W]hen the question is whether a patent claiming the combination of
elements of prior art is obvious,” the answer depends on “whether the
improvement is more than the predictable use of prior art elements according
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to their established functions.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
417 (2007).
The obviousness analysis “can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.” Id. at
418.
Analysis
Van Loo discloses inulin compositions for the treatment or prevention
of colon cancer. Van Loo also discloses that the inulin used in its
composition with an average degree of polymerization of at least 15,
preferably at least 20, and typically about 25. Taper B discloses that adding
oligofructose to rats’ diets reduced the incidence of mammary
carcinogenesis. Taper B also discloses that oligofructose inhibited tumor
growth in mice, and reduces the incidence of induced colonic aberrant crypt
foci. In view of these disclosures, it would have been obvious to one of skill
in the art to combine the oligofructose disclosed by Taper B with the colon
cancer treating composition of Van Loo, because Taper B discloses that
oligofructose was effective in inhibiting growth of both mammary and liver
tumor cells; since oligofructose was shown to be effective against two
different types of cancer cells, a person of ordinary skill in the art would
reasonably expect that it would inhibit growth of colon cancer cells as well.
Appellants argue that the cited references would not suggest the
invention of claim 30 because Van Loo discloses colon cancer treatment
while Taper B discloses breast cancer treatment and “one skilled in the art
would not look to combine … treatment protocols for two different cancer
types” (Appeal Br. 14).
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This argument is not persuasive because, as discussed above, Taper B
discloses that oligofructose was effective against different types of cancer
cells, not just mammary tumors, and therefore it would be reasonably
expected to be effective against colon cancer as well.
Appellants also argue that the Examiner erred in finding that the cited
references suggest the claimed EFI/HFI ratio range of 10/90 to 70/30 (Reply
Br. 6).
This argument is not persuasive. The suggestion in the art of two
components individually as dietary supplements to treat cancer would
suggest the mixture of the two components, because a mixture would be
expected to be more effective than either component alone. And, as
discussed above with respect to the rejection based on Taper A, the
suggestion in the art of a mixture of components for cancer treatment would
suggest optimizing the amounts of the components in the mixture.
Appellants have pointed to no evidence that the mixture suggested by the
prior art would not include an EFI/HFI ratio within the broad range recited
in claim 30.
Finally, Appellants argue that the cited references do not disclose or
suggest the long chain inulin having an average degree of polymerization of
exactly 20 (Reply Br. 6), but claim 30 does not require inulin with an
average degree of polymerization of exactly 20, only an average degree of
polymerization of equal to or greater than 20.
Conclusion of Law
The evidence of record supports the Examiner’s conclusions that one
of skill in the art would have considered it obvious to combine the
oligofructose taught by Taper B with the inulin taught by Van Loo, and that
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the cited references make obvious the EFI/HFI ratio and the long chain
inulin component recited in claim 30.
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a) of claims 30-37 and
39-42 in view of Taper A and of claims 30-37 and 39-42 in view of Van Loo
and Taper B. We reverse the rejection under 35 U.S.C. § 103(a) of claims
51-58 and 60-62 in view of Van Loo.
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-IN-PART

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