Ex Parte Frippiat et al

Patent Trial and Appeal Board

Dec 16, 2015

12822749 (P.T.A.B. Dec. 16, 2015)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/822,749 06/24/2010 Anne Frippiat
27667 7590 12/18/2015
HA YES SOLOWAY P.C.
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.
TIENSE RAFF.31 DIV2 6418
EXAMINER
4640 E. Skyline Drive OLSON, ERIC
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ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
12/18/2015 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANNE FRIPPIAT, JAN VAN LOO, and GEORGES SMITS 1
Appeal2013-07707
Application 12/822,749
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, 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, which have been rejected for obviousness and obviousness-type
double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 Appellants identify the Real Party in Interest as Tiense Suikerraffinaderij
N.V. (Appeal Br. 1.)
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Application 12/822,749
STATEMENT OF THE CASE
"Inulin is a fructan-type carbohydrate, consisting mostly of fructose
units, which occurs in many plants as a reserve carbohydrate." (Spec. 1:13-
14.) The Specification discloses an inulin product that is described as
"presenting improved nutritional properties for humans, mammals and other
vertebrates, compared to known inulin products, without imparting intestinal
side effects." (Id. at 10:13-15.)
Claims 30--43 are on appeal. Claim 30 is illustrative and reads as
follows:
Claim 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
of EFI and HFI ranges from about 35/65 to about 65/35, 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 (DP)?.20.
The claims stand rejected as follows:
Claims 30--43 under 35 U.S.C. § 103(a) as obvious based on Taper2
(Ans. 4);
Claims 30--43 under 35 U.S.C. § 103(a) as obvious based on Liska3
(Ans. 7);
Claims 30--43 for obviousness-type double patenting based on claims
1-21 of U.S. Patent 7,812,004 B2 (Ans. 10-11); and
Claims 30--43, provisionally, for obviousness-type double patenting
based on claims 30-59 of application 11/551,592 (Ans. 12).
2 Taper et al., WO 99/59600, published Nov. 25, 1999.
3 Liska et al., U.S. 6,051,260, issued Apr. 18, 2000.
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l
The Examiner has rejected all of the claims on appeal for
obviousness-type double patenting based on the '004 patent, and
provisionally rejected all of the claims for obviousness-type double
patenting based on the '592 application. (Ans. 10-13.)
Appellants do not present any arguments with respect to either double
patenting rejection, and state that they "will file the necessary Terminal
Disclaimer upon indication of allowability of one or more claims of the
instant application." (Reply Br. 10.)
Because Appellants do not contest the rejection or provisional
rejection for obviousness-type double patenting, we affirm them.
II
Issue
The Examiner has rejected all of the claims on appeal as obvious
based on Taper. (Ans. 4.) The Examiner finds that "Taper et al. discloses a
pharmaceutical composition comprising inulin and an anti-metabolic anti-
cancer drug" (id. at 5), and also discloses that "the compositions can contain
a chicory inulin, an[] oligofructose, or a mixture thereof." (Id.) The
Examiner finds that Taper discloses that "[ s Jui table inulins include ... the
chicory inulins Raftiline® HP, having a degree of polymerization of over 23,
and Raftilose® P95, a short-chain oligofructose with a degree of
polymerization ranging from 2 to 7." (Id.)
The Examiner concludes that it would have been obvious "to produce
a mixture of high- and low- DP inulins according to Taper" because Taper
discloses mixtures of inulin having a DP of at least 23 and oligofructose
with a DP of less than 10. (Id. at 6-7.) With regard to the ratios recited in
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claim 30, the Examiner concludes that "optimizing the ratio of the prior art
inulins to the broad range disclosed in the art is well within the ordinary and
routine level of skill in the art." (Id. at 7.)
Appellants contend that the inulin and oligofructose embodiments of
Taper are mutually exclusive. (Appeal Br. 6.) Appellants also contend that
optimizing the ratio of the two components would not have been obvious
because "the cited art teaches EFI and HFI as a single interchangeable
ingredient" and "treats the two groups as entirely fungible" (id. at 7), and
thus, "there is no indication in the prior art that effectiveness of the
therapeutic is a function of the concentration or ratio of EFI to HFI." (Id. at
9.) Appellants also contend that they have provided evidence of unexpected
results to rebut any prima facie case of obviousness. (Id. at 10-11.)
The issues with respect to this rejection are (1) whether Taper would
have made obvious a product meeting the limitations of claim 30, and (2)
whether Appellants have provided evidence of unexpected results that, when
weighed with the evidence favoring obviousness, shows that the product of
claim 30 would have been nonobvious.
Findings of Fact
1. Taper 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 7).
2. Taper states that "[i]nulin mostly occurs as a polydisperse mixture
of linear polyfructose molecules, as for example inulin from chicory, but
inulin can also occur as a polydisperse mixture of branched polyfructose
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molecules, as for example inulin from dahlia and inulin from agave." (Id. at
4:7-10.)
3. Taper states that "[i]nulin from chicory is commercially available
in various grades, for example as RAFTILINE® from ORAFTI." (Id. at
5:4-5.)
4. Taper states that RAFTILINE® grades include "HP (which has a
(DP) 2 23)." (Id. at 5:6-9.)
5. Taper states that "[s]everal grades of oligofructose are
commercially available, for example from ORAFTI (Tienen, Belgium)
under the brand name RAFTILOSE®, for example, RAFTILOSE® P95
which contains about 95 % by weight oligofructose with a degree of
polymerisation (DP) ranging from 2 to 7." (Id. at 5:22-25.)
6. Taper provides a working example showing that both inulin and
oligofructose ("FOS," or fructooligosaccharide; id. at 12:8) provided a
synergistic effect when combined with the anticancer drug methotrexate.
(Id. at 15:1-10.)
7. The Specification states that "grades of oligofructose which are
suitable as EFI component of the industrial grade inulin product according to
the invention are RAFTILOSE® L85, RAFTILOSE® L95, and
RAFTILOSE® P95, which are all oligofructose grades obtained by
enzymatic hydrolysis of chicory inulin." (Spec. 13:31 to 14:3.)
8. Taper discloses that "[i]n a preferred embodiment the inulin is a
chicory inulin with a (DP) of about 10. In another preferred embodiment the
inulin is a chicory inulin with a (DP) of 2 23." (Taper 8:25-27.)
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9. Taper 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.)
10. Taper discloses that "[i]n a particularly preferred embodiment the
inulin is chicory inulin or oligofructose or a mixture thereof and the
anticancer drug is 5-fluorouracil or methotrexate." (Id. at 8:32-34).
11. The Specification states that "the inventors surprisingly found
that the amount of EFI present in the inulin products of the invention exerts
such a pronounced activating effect on the intestinal flora that the amount of
HFI present in said products is readily and completely fermented in the
distal part of the large intestine." (Spec. 21: 14-18.)
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 (DP) 2: 20, with an EFI/HFI weight ratio between 35/65
and 65/35. Claim 30 also requires the product to be free from agave inulin.
Taper discloses a pharmaceutical composition comprising a
combination of inulin and an anti-cancer drug (FF 1 ), and discloses that the
inulin is preferably an oligofructose with a (DP) of 2-7 (FF9) or chicory
inulin with a (DP) of either about 10 or 2: 23 (FF8), or a mixture of
oligofructose and chicory inulin (FFlO). In view of the express suggestion
in Taper of a composition comprising a mixture of chicory inulin and
oligofructose, it would have been obvious to one of ordinary skill in the art
to combine chicory inulin with a (DP) of 2: 23 with oligofructose with a
(DP) of 2 to 7, because Taper discloses that those species are among its
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preferred forms of inulin. It would also have been obvious to use
RAFTILOSE® P95 as the oligofructose, because Taper discloses that it is
commercially available (FF5). The composition made obvious by Taper is,
thus, free from agave inulin.
Appellants argue that "Taper teaches two mutually exclusive
embodiments of two elements, namely chicory inulin and oligofructose."
(Appeal Br. 6.) We disagree, because Taper expressly suggests mixtures of
inulin and oligofructose.
Appellants also argue that Taper "teaches EFI and HFI as a single
interchangeable ingredient" and "lumps both EFI and HFI into a single
group (inulins) and treats the two groups as entirely fungible." (Id. at 7.)
Appellants argue that "[ n ]owhere in the cited art are EFI and HFI taught to
be separate, and therefore variable in concentration, active ingredients" (id.
at 8) and "there is no indication in the prior art that effectiveness of the
therapeutic is a function of the concentration or ratio of EFI to HFI." (Id. at
9.)
This argument is unpersuasive, because Taper discloses that each of
inulin or oligofructose provides a synergistic anticancer effect when
combined with methotrexate (FF6). A skilled worker would therefore have
expected that a combination of inulin and oligofructose with methotrexate
would also have provided a similar effect. Thus, a skilled worker would have
had a reason to combine the two compounds in different ratios in order to
optimize the synergistic effect when they are combined with methotrexate.
Appellants also argue that "unlike typical ranges, the range specified
in Appellants' claims is asymmetrical in favor of the HFI compound 35/65
to 65/35." (Appeal Br. 10.) We disagree with Appellants' premise: the
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recited range of ratios encompasses amounts including 50/50, with a 15%
variation for either component in either direction. The range is not
asymmetrical with respect to either the EFI or HFI component.
Finally, Appellants argue that they have provided evidence of
unexpected results (id.):
Appellants "surprisingly found that the amount of EFI present
in the inulin products of the invention exerts such a pronounced
activating effect on the intestinal flora that the amount of HFI
present in said products is readily and completely fermented in
the distal part of the large intestine." (Specification at page 21,
lines 14-18). Pages 22 - 34 of the specification are then
dedicated to experimental evidence of the existence of this
unexpected result of the invention.
(Id. at 11.)
We have reviewed the cited portion of the Specification but conclude
that the proffered evidence does not show that the claimed product would
have been nonobvious. As quoted above, the Specification states that
Appellants found that the amount of EFI in the claimed product affects the
degree of fermentation of the HFI component in the large intestine (FF 11 ).
The Specification, however, does not present evidence that supports
this statement. The Specification provides the following working examples:
(1) a comparison of the effects of oligofructose (EFI) alone, long-chain
inulin (HFI) alone, and a mixture of EFI and HFI at a ratio of 45/55 on
absorption of calcium in rats (Spec. 22-24); (2) a comparison of
oligofructose and a mixture of EFI and HFI at a ratio of 45/55 on calcium
absorption in humans (id. at 24-27); (3) a comparison of oligofructose and a
mixture of EFI and HFI at a ratio of 45/55 on magnesium absorption in rats
(id. at 27-28); (4) a comparison of EFI alone, HFI alone, and a mixture of
EFI and HFI at a ratio of 45/55 on lipid metabolism in rats (id. at 29-30);
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and (5) a comparison of EFI alone, HFI alone, and a mixture of EFI and HFI
at a ratio of 45/55 on azoxymethane-induced carcinogenesis in rats (id. at
30-34).
None of the data presented, however, shows a comparison of different
ratios of EFI to HFI, as implicated by the Specification's statement that the
amount of EFI is critical to "activating ... the intestinal flora [so] that the
amount of HFI present in said products is readily and completely fermented"
(FF 11 ). The only EFI/HFI ratio that was assayed in any of the working
examples is 45/55. The Specification therefore does not provide evidence
that the amount of EFI "surprisingly" affected the degree of fermentation of
the HFI component (FF 11 ).
In addition to not supporting the Specification's assertion of
surprising results, the data presented are not commensurate in scope with the
claims, which encompass EFI/HFI ratios of 35/65 to 65/35. That is, even if
we were to accept the Specification's statement that "the amount of EFI
present in the inulin products of the invention exerts such a pronounced
activating effect on the intestinal flora that the amount of HFI present in said
products is readily and completely fermented" (FF 11 ), that statement itself
suggests that other amounts of EFI-that is, other EFI/HFI ratios-would
not provide the same effect as was produced by the 45/55 ratio assayed in
the Specification. Thus, even if Appellants' data supported the assertion of
unexpected results, the data are not commensurate in scope with the claims
and therefore would not overcome the prima facie case of obviousness.
Conclusion of Law
Taper would have made obvious a product meeting the limitations of
claim 30. Appellants have not provided evidence of unexpected results that,
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when weighed with the evidence favoring obviousness, shows that the
product of claim 30 would have been nonobvious.
Claims 31--43 have not been argued separately and therefore fall with
claim 30. 37 C.F.R. § 41.37(c)(l)(iv).
III
Issue
The Examiner has rejected all of the claims on appeal as obvious in
view of Liska. The Examiner finds that Liska discloses "a medical food
composition comprising ... approximately 2.7 to 4.0% by weight of
fructooligosaccharides (corresponding to short-chain inulin, i.e. EFI), [and]
approximately 1.9 to 2.8% by weight of inulin." (Ans. 7.) The Examiner
also finds that, "since the amounts of fructooligosaccharides and inulin in
the composition are 2.7 to 4.0% and 1.9 to 2.8% by weight respectively,
therefore, the weight ratios of EFI and HFI in the compositions are from
about 2.7%/2.8% to 4.0%/1.9%, i.e. from about 49/51 to 68/32." (Id. at 8.)
The Examiner finds that Liska does not "expressly teach that EFI
component is free of agave inulin" but states that "[t]he sources of inulin and
fructooligosaccharides are chicory." (Id.)
Appellants contend that "Liska ... makes no mention whatsoever of
the number average degree of polymerization, DP, of the inulin molecules
added to the food composition taught therein. Rather, the only characteristic
of the inulin molecules that Liska discloses is the degree of polymerization,
DP." (Appeal Br. 13.) Appellants argue that their Specification makes clear
that DP and DP are different characteristics (id. at 12-13); specifically, "the
degree of polymerization describes only an individual polymer molecule,
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while the number average degree of polymerization necessarily describes an
entire sample of polymer molecules." (Id. at 13.) Appellants argue that,
therefore, Liska would not "motivate one of ordinary skill in the art to utilize
inulin with an average number degree of polymerization greater than or
equal to twenty, as is required by claim 30." (Id. at 14.) Appellants also
argue that their evidence of unexpected results shows that claim 30 would
not have been obvious. (Id.)
The issues with respect to this rejection are (1) whether Liska would
have made obvious a product meeting the limitations of claim 30, and (2)
whether Appellants have provided evidence of unexpected results that, when
weighed with the evidence favoring obviousness, shows that the product of
claim 30 would have been nonobvious.
Findings of Fact
12. Liska discloses "a medical food composition comprising: ...
approximately 2.7 to 4.0 percent by weight of fructooligosaccharides; [and]
approximately 1.9 to 2.8 percent by weight of inulin." (Liska 4: 13-32.)
13. Liska states that "commercially feasible sources of
fructooligosaccharides are products available from RhOne-Poulenc
(Cranbury, N.J.), known under the trade name RAFTILOSE P95®." (Id. at
7:37--40.)
14. Liska states that "inulin is the common and joint name for certain
carbohydrate molecules where one glucopyranosyl unit is coupled to several
fructose units in varying degrees of polymerization (DP); with the lower
limit being generally recognized as 5 fructose units .... The upper limit for
inulin is usually considered a DP of 50." (Id. at 7:54-64.)
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15. Liska states that "various plant species including chicory contain
inulin with various average degree of polymerization. For example, inulin
obtained from chicory has an average DP of 9, and inulin from dahlia plants
has an average DP of 30." (Id. at 7:65 to 8:2.)
Analysis
We agree with the Examiner that the product of claim 30 would have
been obvious based on Liska's disclosure. Liska discloses a product that
includes, among other things, fructooligosaccharide (2.7--4.0% by weight)
and inulin (1.9-2.8% by weight) (FF12). Liska discloses that one
commercially available fructooligosaccharide is RAFTILOSE P95® (FF13),
which is identified in the Specification as being suitable as the EFI
component of the claimed product (FF7). Liska also states that inulin from
dahlia plants has an average DP of 30 (FFl 5), meeting the requirement of
claim 30 of an HFI component with a DP of 2: 20.
It would have been obvious to use RAFTILOSE P95® and dahlia
inulin in Liska' s composition because Liska expressly identifies those
products as a fructooligosaccharide and an inulin, respectively. The
Examiner has calculated that the ratio of weight percent ranges taught by
Liska overlaps the range recited in claim 30. (Ans. 8.) Appellants have not
pointed to any flaw in the Examiner's calculation.
Appellants argue that Liska only discloses the degree of
polymerization (DP) of the inulin in its product, not the average degree of
polymerization (DP), and the Specification makes clear that the two
characteristics are different. (Appeal Br. 12-13.) Appellants argue that
there is "no teaching or suggestion in Liska that would motivate one of
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ordinary skill in the art to utilize inulin with an average number degree of
polymerization greater than or equal to twenty, as is required by claim 30."
(Id. at 14.)
These arguments are not persuasive because Liska expressly identifies
dahlia inulin as one that has an average degree of polymerization of 30
(FF 15). This express disclosure would have provided a reason for a person
of ordinary skill in the art to use dahlia inulin in Liska's product, thus
meeting the HFI requirement of claim 30.
Appellants also point to their evidence of unexpected results but, for
the reasons discussed above regarding the rejection based on Taper, that
evidence is not probative of nonobviousness.
Conclusion of Law
Liska would have made obvious a product meeting the limitations of
claim 30. Appellants have not provided evidence of unexpected results that,
when weighed with the evidence favoring obviousness, shows that the
product of claim 30 would have been nonobvious.
Claims 31--43 have not been argued separately and therefore fall with
claim 30. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm all of the rejections on appeal.
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. § l.136(a).
AFFIRMED
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lp
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