Aside

Practical Considerations for Using Evidence of Unexpected Synergistic Results in Patent Prosecution

Author: Kevin Tamm, Managing Editor, University of Cincinnati Law Review

I. Distinguishing a Patent Over the Prior Art with Unexpected Synergistic Results

The Federal Circuit and USPTO have set a high bar for an inventor to overcome a finding of obviousness in a patent application by using evidence of unexpected synergistic results.  Synergy by itself is not enough to overcome an examiner’s prima facie case for obviousness; instead, the synergy must be unexpected or surprising and the applicant must show that it could not have been predicted based upon the cited references.  Broad disclosures of synergy in the prior art weigh toward a finding of obviousness.  Additionally, evidence of synergy over a broad range of compositions or components in the prior art, or in the application at issue, weighs toward a finding of obviousness.  To show unexpected results, an applicant must provide a side-by-side comparison of the claimed invention with the closest prior art and explain why the results would have been unexpected by one of ordinary skill in the art.[1]

More often than not, arguments against obviousness based on unexpected synergy fail.  However, in Ex Parte Morgan, 2012 WL 4500673 (Bd. Pat. App. & Interf. Sept. 27, 2012), the applicants successfully distinguished the invention over inventions in two pieces of prior art where it was shown that “peak metabolic readings” obtained in the two prior art references were in fact significantly lower than those obtained in the application at issue.[2]  In Ex Parte Ashmore, 2012 WL 170662 (Bd. Pat. App. & Interf. Jan. 17, 2012), the applicants successfully distinguished the invention from the prior art with a declaration stating “those skilled in the art of biocide formulation and testing … would have been aware that biocide synergy is not predictable.”  Additionally, the prior art at issue disclosed that some, not all, combinations may exhibit a synergistic effect.[3]

To show synergy, the applicant must prove the invention exhibits more than mere additive effects.  The effectiveness of the combination should be shown vs. the individual components, and the effectiveness also should be shown over what the closest cited prior art suggests.  In Ex Parte Quadranti, 25 U.S.P.Q.2d 1071, (Bd. Pat. App. & Interf. May 22, 1992), the Board found evidence of unexpected synergy to be unpersuasive stating:

[G]eneralizations such as the Colby formula[4] are not particularly useful in determining whether synergism has been demonstrated, since the formula inherently results in expectation of less than additive effect for combination of herbicides, since there is no evidence that such approach is considered valid by significant number of ordinarily skilled workers in relevant area of technology, and since it could be reasonably argued that in most cases, additive or better than additive results could be expected for combination of herbicides.  (emphasis added).

However, in Ex Parte Mudge, 2010 WL 4670640 (Bd. Pat. App. & Interf. Nov. 16, 2010), the Board found the invention nonobvious in light of evidence of synergism, where the combination of prior art taught the claimed invention, but where neither piece of prior art disclosed synergistic activity.  The Board stated:

[The prior art] are relied on for their teaching that green dye or pigment Blue 15 can be applied to brown dead lawn areas in turfgrass to restore the desired green appearance. No synergistic activity is disclosed . . . . The cited prior art discloses coloring of turf grass but does not disclose that the coloring has a synergistic fungicidal effect in combination with a phosphorus acid, as claimed.  (emphasis added).

II. Scope of the Claimed Invention

The claimed invention must be commensurate in scope with the unexpected synergistic results provided in the specification or in a declaration.  Parties often fail to show how the data evidencing synergy is commensurate in scope with the subject matter claimed.  However, if an applicant demonstrates that an embodiment has an unexpected result and provides an adequate basis to support the conclusion that the other embodiments falling within the claim will behave in the same manner, this will generally establish that the evidence is commensurate with the scope of the claims.[5]  In Ex Parte Giles, 2010 WL 227990 (Bd. Pat. App. & Interf. Jan. 20, 2010), the applicants failed to show that the claims were commensurate in scope with the data evidencing synergy.  The Board stated:

Appellants’ data is not commensurate in scope with the subject matter of claim 1.  For example, the claims encompass a compound of claim 1 having any stereochemistry, while the purported evidence of unexpected results is drawn only to the one enantiomer, (-)-L-OddC… Appellants have not provided any evidence that the ordinary artisan would expect the different enantiomers to have the same activity . . . . (emphasis added).

In Ex Parte Helvoort, et al., 2010 WL 2642006 (Bd. Pat. App. & Interf. June 30, 2010), the Board found that the evidence of unexpected results was not commensurate in scope with the claims stating:

[T]he results set forth in the Specification and the van Helvoort Declaration are limited to “specific amounts and ratios of active agents.”  The method of claim 19 is not limited to the administration of any specific amount of active agent or the administration of active agents in any specific ratio of concentrations. Accordingly, Appellants’ evidence of unexpected results  . . . is not commensurate in scope with the claimed invention.  (emphasis added).

Similarly, in Ex Parte Kokko, 2009 WL 3816886 (Bd. Pat. App. & Interf. Nov. 12, 2009), the Board found the appellant was not specific in describing and arguing evidence of unexpected synergy.  The Board stated:

The Appellant, however, does not explain with any reasonable degree of specificity how the relied-upon evidence shows unexpected results.  To show unexpected results the Appellant must provide a side-by-side comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims, and explain why the results would have been unexpected by one of ordinary skill in the art, and the Appellant has not done so.

Finally, in Ex Parte Peyton, 1996 WL 33103152 (Bd. Pat. App. & Interf. Jan. 1, 1996), the Board found the claims broader than the synergy disclosed in the specification and stated:

In this regard, the tested compositions referred to in appellants’ specification involve the blends of very specific copolymers ….  The appealed claims, however, are much broader in scope, covering numerous other OMA copolymer components ….  Thus, we find no adequate basis for concluding that the great number of compositions included by the appealed claims would behave in the same manner as the tested compositions.  (emphasis added).                                                                                                                                        

III. Declarations

Declarations evidencing synergy can aid in overcoming the Examiner’s prima facie case for obviousness; however, to be effective a declaration should provide objective evidence or point to where in the Specification data is presented that shows the results obtained using the claimed composition are unexpectedly better than those obtained with the compositions of the closest prior art.  Arguments supporting unexpected results cannot take the place of a declaration providing objective evidence or noting in the specification why the results are unexpected.

Declarations must be specific and should refer to factual data in the Specification.  In Ex Parte Levy et al., 2010 WL 4913982 (Bd. Pat. App. & Interf. Nov. 30, 2010), the Board stated:

[T]he Warwick Declaration is not evidence of unexpected results as it does not provide evidence or point to where in the Specification data is presented that shows that the results obtained using the claimed composition are unexpectedly better than those obtained with the compositions of the closest prior art. (emphasis added).

Similarly, in Ex Parte Cheney,et al., 2008 WL 5371880 (Bd. Pat. App. & Interf. Dec. 22, 2008), the Board found the declaration supporting unexpected synergy to be unpersuasive.  The Board stated:

[T]he data provided in the Miner Declaration do not show results obtained with tapioca alone without polyacrylic beads and thus it cannot be determined from the data provided whether synergistic results are obtained with the combination . . . .  Unexpected results must be established by factual evidence, and Appellants have not provided evidence of unexpectedly superior skin feel . . . .  (emphasis added).

Thus, based on the preceding cases and Ex Parte Cameron et al., 2010 WL 4138402 (Bd. Pat. App. & Interf. Oct. 18, 2010), the specification should explicitly provide and explain the unexpected synergistic results and compare them to individual elements in the prior art.  The Board in Ex Parte Cameron stated:

[T]he Specification does not provide any explanation or discussion relating the study results to the conclusion that the results indicated a marked synergistic interaction between the drugs. In particular, what is missing from the Specification is a discussion of why the reported results reflect a synergistic interaction between the tested drugs rather than merely reflecting an additive effect resulting from administering two drugs each known to improve nerve conduction velocity, blood flow, and vascular conductance.  (emphasis added).

 IV. The Federal Circuit

Recent Federal Circuit case law follows the Board, in the sense that it applies rigid requirements to succeed on a showing of unexpected synergy.  In Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1362-64 (Fed. Cir. 2012), Wrigley failed to show unexpected synergy, because its actual results were not far above and beyond those results obtained in the closest prior art.  The court explained:

[Prior Art I] disclosed a “synergy” between menthol and WS–3, when menthol was included in high amounts, and disclosed that the combination produced an “enhanced breath-freshening effect” in which each component played “a vital role.”  [Prior Art II] identified WS–3 and WS–23 as especially favored cooling agents for commercial use from among 1200 tested compounds that induced a cooling effect . . . .  Therefore, to show that the cooling effect . . . was unexpected, Wrigley needed to demonstrate that the results were unexpected to a significant degree beyond what was already known about the effect of combining WS–3 and menthol.  (emphasis added).

 V. Additional Guidance

Different types of synergy disclosed in the prior art, if considered a “strong teaching of synergy” may be transposed to inventions with more or less elements.  In Ex Parte Kibler et al., 2010-004960, 2010 WL 4876388 (Bd. Pat. App. & Interf. Nov. 29, 2010), the Board found that a four-component mixture would be expected to display non-additive synergistic effects in the same way as the two- and three-component mixtures in the prior art.  However in that case the Board found a “strong teaching of synergy” and a “clear trend in the prior art toward synergy.”

Strong statements of synergy in the prior art weigh heavily toward a finding of obviousness.  In Ex Parte Duvert, 2012 WL 2450706 (Bd. Pat. App. & Interf. June 22, 2012), the Board stated:

Furthermore, we conclude that any weaknesses in the actual data in Maeno is outweighed by the strong statements of synergy and improved effects described in three different publications for different compound combinations.

VI. Conclusion and Summary Guidelines

Using evidence of synergy to overcome an Examiner’s prima facie case for obviousness is difficult; however, with (1) a detailed specification, (2) claims commensurate in scope with unexpected synergistic results, (3) well-reasoned arguments, and (4) declarations with objective facts, an applicant’s chances of success are increased.


[1] See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991); In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983); In re Clemens, 622 F.2d 1029, 1035 (CCPA 1980); In re Freeman, 474 F.2d 1318, 1324 (CCPA 1973); In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972).

[2] “The highest (i.e., peak) metabolic activity reading for any of the prior art compositions was 1.3 mV, which was reached by the 1% sodium chlorite Danner composition” and the “peak metabolic activity for Oge was only 0.90 mV.”  We agree with Appellant that the evidence of unexpected results presented in the Morgan Declaration is sufficient to rebut the prima case of obviousness . . . .  [T]he peak metabolic activity of the compositions corresponding to the prior art never exceeded 1.30 mV, which is far below the 30 mV recited in claim 1 as well as the 140.85 mV found for the composition corresponding to the claims.”  Ex Parte Morgan, 2012 WL 4500673 (Bd. Pat. App. & Interf. Sept. 27, 2012) (internal quotes omitted).

[3] The Board found, “even if the Examiner’s rejection contemplated combining DCOIT and micronized copper with a peptidic agent, the Examiner fails to establish an evidentiary basis to support a conclusion that a person of ordinary skill in this art, at the time of Appellants’ claimed invention, would have reasonably expected the resulting composition to exhibit synergistic properties.”  Ex Parte Ashmore, 2012 WL 170662 (Bd. Pat. App. & Interf. Jan. 17, 2012).

[4] Colby Equation: “Expected Result = A + B – (A x B/100)” where A = observed efficacy of active component A at the same concentration as used in the mixture; B = observed efficacy of active component B at the same concentration as used in the mixture.

[5] See In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011).

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