Hayes Soloway, P.C.

Case Results

Ex parte ANNE FRIPPIAT, JAN VAN LOO and GEORGES SMITS

April 2010

STATEMENT OF THE CASE

(Reprinted from the Opinion of the Board)

Appeal 2009-010881
Application 10/182,064

The Specification discloses that “[i]nulin is a fructan-type carbohydrate, consisting mostly of fructose units, which occurs in many 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 longchain 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 shortchain 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).

The claims stand rejected under 35 U.S.C. § 103(a) as follows:
• claims 30-37 and 39-42 in view of Taper A;
• claims 51-58 and 60-62 in view of Van Loo; and
• claims 30-37 and 39-42 in view of Van Loo and Taper B.

Issue I.

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 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.)
5. Taper A 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).
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 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 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). 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 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.

Issue II

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 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 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 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.

Issue III

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?

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 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).

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 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.

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Nick Soloway

Nick Soloway, an AV Peer Review Rated* attorney, is one of 200 practicing patent attorneys in the United States to be included in Woodward/White's Best Lawyers in America.
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