Case: 16-1280 Document: 1-2 Page: 5 Filed: 12/03/2015 (6 of 57) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte VIRUN, INC. Appellant Patent 8,282,977 Technology Center 3900 Before BRADLEY R. GARRIS, KAREN M. HASTINGS, and CHRISTOPHER M. KAISER, Administrative Patent Judges. GARRIS, Administrative Patent Judge. DECISION Appellant appeals from the decision of the Patent Reexamination Specialist to reject claims 1, 2, 7, 9-26, and 28-36, which are all of the claims now pending in this ex parte reexamination proceeding. We have jurisdiction based on 35 U.S.C. 6, 134, and 306. We AFFIRM. Background Patent No. US 8,282,977 B2 issued October 9, 2012. On the October 9, 2012 issue date, a request for ex parte reexamination of all claims of this patent (i.e., claims 1-35) was filed by a Third-Party Requester pursuant to
35 U.S.C. 302-307 and 37 C.P.R. 1.510. The request was granted. In the Final Action dated September 23, 2013, the Specialist maintained rejections of the claims on appeal. The subject appeal followed. Appellant claims a liquid nanoemulsion concentrate comprising a PEG-derivative of Vitamin E, namely, tocopherol polyethylene glycol 1000 succinate (TPGS-1 000), a polar solvent, and a non-polar active ingredient (claim 1) as well as a method for preparing a powder which comprises spray- or freeze-drying the liquid nanoemulsion concentrate (claim 29) and a method of providing an oil-based additive in a beverage which comprises adding the liquid nanoemulsion concentrate to an aqueous medium (claim 33). A copy of representative claim 1, taken from the Claims Appendix of the Appeal Brief, appears below with bracketing and underlining respectively identifying subject matter deleted from or added to claim 1 of the patent. Case: 16-1280 Document: 1-2 Page: 6 Filed: 12/03/2015 (7 of 57) 1. A liquid nanoemulsion concentrate, comprising: a PEG-derivative of Vitamin E in an amount between 16% and 30% [or about 30%], by weight, of the concentrate.l. wherein the PEG-derivative of Vitamin E is a tocopherol polyethylene glycol 1000 succinate (TPGS-1 000); a polar solvent in an amount between about 60% and 79% by weight, of the concentrate; and a non-polar active ingredient selected from among any one or more of polyunsaturated fatty acids, Coenzyme Q 10 compounds and phytosterols, wherein the non-polar active ingredient is present in an amount between 5% or about 5% and 10% or about 10%, by weight, of the concentrate, wherein: the concentrate is a liquid nanoemulsion concentrate. 2
Case: 16-1280 Document: 1-2 Page: 7 Filed: 12/03/2015 (8 of 57) The Rejections based on Borowy-Borowski et al. (US 6,045,826 issued Apr. 4, 2000, hereinafter Borowski 826) Under 35 U.S.C. 103(a), the Specialist rejects claim 1 as unpatentable over Borowski 826 and rejects the remaining claims on appeal as unpatentable over this reference alone or in combination with additional prior art (Final Action 7-19). These rejections rely on the Specialist's finding that the concentrates of Borowski 826 are inherently nanoemulsion concentrates as required by claim 1 (id. at 10; Ans. 19,,-r bridging 59-60). It is undisputed that Borowski 826 does not expressly teach the disclosed concentrates are in the form of an emulsion. Further, the Specialist does not identify any Borowski 826 disclosure of preparation steps (e.g., a homogenization step) that unquestionably and necessarily would produce an emulsion concentrate. Most significantly, Appellant's challenge of the Specialist's finding includes evidence, in the form of a Declaration under 37 C.P.R. 1.132 dated May 6, 2013 by Philip J. Bromley (hereinafter Declaration I), that procedures exemplified by Borowski 826 do not yield an emulsion concentrate (see, e.g., App. Br. 21-22, Decl. I 3-5). The Specialist considers this Declaration I evidence to be contradicted by another 1.132 Bromley Declaration of record dated November 25,2013 (hereinafter Declaration II). According to the Specialist, "Declaration II proves that using a similar method as in Borowski '826 results in a nanoemulsion concentrate, as here claimed" (Ans. 61 ). However, the Specialist does not explain why the methods of Declaration II and Borowski 826 are believed to be similar such that both produce a nanoemulsion. In 3
contrast, Appellant provides a detailed exposition of differences between these methods whereby an emulsion is formed in Declaration II but not in Borowski 826 (Reply Br. 11-12). The Specialist also disparages the evidentiary value of Declaration I by stating that Mr. Bromley's failure to achieve nanoemulsions in reproducing the Borowski 826 examples may have been due to "no interest in succeeding" (Ans. 62) and correspondingly that "[i]t is to be presumed that skilled workers would as a matter of course, if they do not immediately obtained desired results make certain experiments and adaptations, within the skill of the competent worker" (id.; emphasis added). The clear deficiency of the Specialist's statement is that Borowski 826 contains no teaching that nanoemulsions are desired results. As expressly conceded by the Examiner, "Borowski '826 does not use the terminology 'nanoemulsion' to describe the solubilized concentrates" (id. at 59). The arguments and evidence in the record of this appeal lead us to determine that the Examiner erred in finding the Borowski 826 concentrates are inherently nanoemulsion concentrates. 826. Case: 16-1280 Document: 1-2 Page: 8 Filed: 12/03/2015 (9 of 57) We do not sustain, therefore, the 103 rejections based on Borowski The Rejection based on Borowy-Borowski et al. (US 2008/0254188 A1 published Oct. 16, 2008, hereinafter Borowski 188) Under 35 U.S.C. 103(a), the Specialist also rejects claims 1, 2, 7, 9-26, and 28-36 (i.e., all appealed claims) as unpatentable over Borowski 188 (Final Action 19-28). 4
Case: 16-1280 Document: 1-2 Page: 9 Filed: 12/03/2015 (10 of 57) The Specialist finds that Borowski 188 exemplifies liquid nanoemulsion concentrates of the general type defined by claim 1 except the exemplified concentrates contain a PTS vitamin E derivative as a solubilizing agent rather than the claimed TPGS (id. at 19-21 (citing inter alia Borowski 188,-r,-r 372 and 377)). The Specialist additionally finds that TPGS is a known vitamin E derivative solubilizing agent which is encompassed by the solubilizing agent general formula IV of Borowski 188 (id. at 21 ). Based on these findings, the Specialist concludes that it would have been obvious to prepare the exemplified nanoemulsion concentrates of Borowski 188 using TPGS, for example TPGS-1 000, rather than PTS as the solubilizing agent (id. ). Appellant concedes that TPGS is encompassed by the solubilizing agent general formula of Borowski 188 but nevertheless contends that no prima facie case of obviousness has been established for claim 1 (App. Br. 37-38). Specifically, Appellant argues that Borowski 188 "directs an ordinary artisan away from employing TPGS in its emulsions instead of PTS... despite the knowledge of TPGS-1 000 and its availability in the art" (id. at 38; bolding removed) because "TPGS is not a preferred solubilizing agent [for the Borowski 188 emulsions]" (id.). We agree with the Specialist that Appellant's argument is not persuasive (Ans. 31 ). "A statement that a particular combination is not a preferred embodiment does not teach away absent clear discouragement of that combination." Syntex LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed. Cir. 2005). Appellant fails to identify any clear discouragement in Borowski 188 of a nanoemulsion concentrate comprising TPGS rather than PTS. 5
Case: 16-1280 Document: 1-2 Page: 10 Filed: 12/03/2015 (11 of 57) Appellant relies on the above unsuccessful argument in contesting the establishment of a prima facie case of obviousness for remaining claims 2, 7, 9-26, and 28-36 (App. Br. 39--45) but does not present with any reasonable specificity additional arguments regarding a prima facie case for these claims (see id. ). Appellant also challenges the Borowski 188 rejection via data in Declarations I and II that are said to evince unexpected results with respect to nanoemulsion concentrates containing the claimed TPGS rather than the PTS exemplified by Borowski 188 (see, e.g., App. Br. 48-63; Decl. I 11 (Table 6), 14 (Table 7), 16 (Table 9); Decl. II,-r bridging 1-2, 9-12 (Tables 2-5)). 1 Specifically, Appellant argues "[i]n all cases, Declaration I shows that... dilution compositions of TPGS-containing emulsion concentrates had substantially lower turbidity and were more clear than corresponding dilution compositions ofpts-containing concentrates" (App. Br. 49; bolding removed). Regarding Declaration II, Appellant similarly argues "in all cases, the generated liquid nanoemulsion concentrates containing TPGS- 1 000 produce dilution compositions that have a substantially lower turbidity (NTU), and hence are more clear, than corresponding dilution compositions prepared from PTS-containing nanoemulsion concentrates" (id. at 51-52; bolding removed). 1 Appellant also refers of certain Figures of Declaration I as visually depicting improved clarity when using TPGS rather than PTS (see, e.g., App. Br. 49 and 59). However, these Figures have limited evidentiary value because they are displayed as black and white images in the Image File Wrapper for the subject reexamination proceeding. We emphasize that the Image File Wrapper defines the official file record of this appeal (see 37 C.P.R. 41.30 (2012)). 6
Case: 16-1280 Document: 1-2 Page: 11 Filed: 12/03/2015 (12 of 57) The Specialist gives several reasons for considering Declarations I and II to be not convincing ofnonobviousness (Ans. 34-56). We do not agree with every one of these reasons. However, to the extent outlined below, we find merit in the Specialist's determination that the evidence of Declarations I and II is not reasonably commensurate with the scope of the rejected claims (see, e.g., id. at 36 and 46). See In re Kao, 639 F.3d 1057, 1068 (Fed. Cir. 2011) ("Evidence of secondary considerations must be reasonably commensurate with the scope of the claims."). As repeatedly emphasized by the Specialist and as indicated by Appellant's above quoted arguments, the comparisons which are said to show unexpected results are not the claimed TPGS-containing concentrates and the Borowski 188 PTS-containing concentrates but rather dilution compositions comprising such concentrates diluted in water. In particular, the dilution compositions were prepared by adding 1 gram of each concentrate to 8 ounces of drinking water (Decl. I 11, Decl. II 9). The record contains no direct evidence that the results exhibited by these dilution compositions also would be exhibited by the corresponding concentrates. In the absence of such evidence, we have no way of determining whether one with ordinary skill in this art would consider the claimed TPGS-containing concentrates to exhibit unexpectedly superior turbidity and clarity characteristics relative to the PTS-containing concentrates exemplified by Borowski 188. Appellant appreciates the above distinction between the claims and the comparisons but argues that "the turbidity of the dilution compositions directly correlate[ s ], and thereby directly relate[ s] back to, the turbidity of 7
Case: 16-1280 Document: 1-2 Page: 12 Filed: 12/03/2015 (13 of 57) the nanoemulsion concentrate by the dilution factor used to prepare the dilution compositions" (App. Br. 61; bolding removed). The deficiency of this argument is that it is not supported by direct evidence. For all we know based on the record before us, a comparison of the concentrates claimed by Appellant and exemplified by Borowski 188 would fail to exhibit any meaningful, much less unexpected, difference in turbidity or clarity. Appellant further argues that unexpected results adequate to establish nonobviousness have been shown by the singular use of the claimed concentrates in the specific dilution compositions of the comparative showing (id. at 62-63). As support for this argument, Appellant cites In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987) (id. at 62). Appellant's argument lacks convincing merit because it assumes that the claimed concentrates have been shown to exhibit unexpected results. For the reasons previously discussed, this assumption is not correct. Importantly, even if Declarations I and II were considered to evince that the TPGS-containing concentrates of the claims exhibit apparently unexpectedly superior turbidity results compared to the PTS-containing concentrates exemplified by Borowski 188, Appellant still would fail to establish nonobviousness. "While secondary considerations must be taken into account, they do not necessarily control the obviousness determination." Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014). "'[D]ifferences in degree' of a known and expected property are not as persuasive in rebutting obviousness as differences in 'kind'-i.e., a new property dissimilar to the known property."!d. "When assessing unexpected 8
Case: 16-1280 Document: 1-2 Page: 13 Filed: 12/03/2015 (14 of 57) properties, therefore, we must evaluate the significance and 'kind' of expected results along with the unexpected results."!d. Here, the Examiner finds and Appellant does not dispute that Borowski 188 discloses liquid nanoemulsion concentrates and beverages containing such concentrates which are essentially clear in that they have small median particle sizes and low turbidity values (i.e., the NTU values discussed by Appellant (see, e.g., App. Br. 51-52)) (see, e.g., Final Action 22-23 (citing,-r,-r 29-30 of Borowski 188)). This disclosure shows that Borowski 188 and Appellant share a common goal of producing nanoemulsion concentrates for use in beverages having a desired high clarity and low turbidity property. Accordingly, the asserted turbidity difference between the respective concentrates claimed by Appellant and exemplified by Borowski 188 may be characterized fairly as a difference in degree of a known and expected property (i.e., the property of low turbidity and concomitantly high clarity). Because the lower turbidity results said by Appellant to be exhibited by the claimed TPGS-containing concentrates represent differences in degree, they are not as persuasive in rebutting obviousness as differences in kind involving a property dissimilar from the known property of low turbidity. Bristol-Myers Squibb Co., 752 F.3d at 977. For this reason, our consideration of the record as a whole leads us to determine that Appellant's evidence of lower turbidity differences in degree does not outweigh the substantial evidence of obviousness established by Borowski 188. Additionally, we reiterate that Borowski 188 discloses nanoemulsion concentrates for use in beverages with the goal of obtaining the property of low turbidity and high clarity wherein the concentrate ingredients comprise 9
Case: 16-1280 Document: 1-2 Page: 14 Filed: 12/03/2015 (15 of 57) solubilizing agents that include the TPGS solubilizing agent claimed by Appellant. This Borowski 18 8 disclosure supports a determination that an artisan would have developed the claimed concentrate merely by routine testing of the Borowski 188 solubilizing agents in order to optimize selection of the solubilizing agent which yielded a superior difference in degree for the low turbidity and high clarity property desired by Borowski 188. Therefore, the fact that the claimed TPGS-containing concentrates exhibit a superior known property relative to the PTS-containing concentrates exemplified by Borowski 188 is more indicative of obviousness based on routine optimization than nonobviousness based on unexpected results. This additional analysis reinforces our earlier determination that the record as a whole supports an ultimate conclusion of obviousness. Moreover, as indicated previously, even assuming Appellant showed the claimed concentrates exhibit unexpectedly superior turbidity results, this secondary consideration would be inadequate to overcome the strong showing of obviousness created by Borowski 188. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371-72 (Fed. Cir. 2007) ("The fact that amlodipine besylate was the best of the seven acid addition salts actually tested proves nothing more than routine optimization that would have been obvious to one of ordinary skill in the art... Alternatively,... even if Pfizer showed... unexpectedly superior results, this secondary consideration does not overcome the strong showing of obviousness in this case. Although secondary considerations must be taken into account, they do not necessarily control the obviousness conclusion."). 10
Case: 16-1280 Document: 1-2 Page: 15 Filed: 12/03/2015 (16 of 57) In summary, Appellant's arguments and evidence regarding unexpected results are not persuasive of patentability with respect to any of the rejected claims for the reasons stated above. Accordingly, we sustain the 103 rejection of all appealed claims as unpatentable over Borowski 188. Conclusion The decision of the Specialist is affirmed. 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 bar 11
Case: 16-1280 Document: 1-2 Page: 16 Filed: 12/03/2015 (17 of 57) Patent Owner STEPHANIE SEIDMAN MCKENNA LONG & ALDREIDGE LLP 4435 EASTGATE MALL SUITE400 SAN DIEGO, CA 92121 Third Party Requester HANSRA INTELLECTUAL PROPERTY LAW 1313 E MAPLE STREET SUITE 223 BELLINGHAM, W A 98225 12