Ex Parte YuDownload PDFPatent Trial and Appeal BoardMay 17, 201612476547 (P.T.A.B. May. 17, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/476,547 0610212009 33357 7590 05/19/2016 ABBOTT MEDICAL OPTICS INC 1700 E. ST. ANDREW PLACE SANTA ANA, CA 92705 FIRST NAMED INVENTOR Zhi-Jian Yu 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. 27761 5671 EXAMINER FAY,ZOHREHA ART UNIT PAPER NUMBER 1621 NOTIFICATION DATE DELIVERY MODE 05/19/2016 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): PatentMGR@abbott.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte ZHI-JIAN YU Appeal2013-005893 1 Application 12/476,5472 Technology Center 1600 Before DONALD E. ADAMS, LORA M. GREEN, and FRANCISCO C. PRATS, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL This appeal under 35 U.S.C. § 134(a) involves claims to an ophthalmic topical liquid composition in the form of an oil-in-water emulsion. The Examiner rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE As background, the Specification explains that oil-in-water emulsions "generally comprise an aqueous phase having suspended therein discrete oil droplets (particles) surrounded by a layer of at least one water soluble 1 The Real Party in Interest is Abbott Medical Optics, Inc. App. Br. 3. 2 As related appeals, Appellant identifies applications 12/476,579 (Appeal 2013-005894) and 12/476,600 (Appeal 2013-004196). App. Br. 3. Appeal2013-005893 Application 12/476,547 surfactant." Spec. if 3. The Specification states that "[t]he term 'particle' as used herein refers to a spherical oil droplet suspended in the aqueous phase of an oil-in-water emulsion." Id. if 41. As further background, the Specification explains that, because emulsion stability is primarily a function of particle size, oil-in-water- emulsions with particle sizes exceeding 1 µm in diameter "tend to be less stable and undergo creaming, coagulation and phase separation upon storage. Therefore, for most applications it is desirable to reduce particle size which generally results in significant increases in aqueous phase surfactant concentration." Id. if 3. When used in emulsions for ophthalmic use, however, the increased amount of surfactant required to reduce particle size can exacerbate conditions such as dry eye. Id. if 5. The Specification discloses that "[ s ]urprisingly, the present inventor has discovered that by closely matching the surfactant system with the oil component, the adverse effects resulting from excessive amounts of free surfactant can be avoided while simultaneously achieving the desired particle size and thus improving the therapeutic emulsion's overall performance." Id. if 52. More specifically, the Specification discloses: The present inventor surprisingly discovered that [by] combining an oil soluble/water insoluble surfactant (hydrophobic surfactant) with a hydrophilic surfactant the total amount of free hydrophilic surfactant in the aqueous phase was remarkably reduced; but only in combination with a non-polar oil. In fact, the present inventor discovered that merely adding a hydrophobic surfactant to the prior art combination of castor oil and a hydrophilic surfactant actually increased the amount to free hydrophilic surfactant in the aqueous phase and thus exacerbated eye irritation. Id. if 53. 2 Appeal2013-005893 Application 12/476,547 Claims 11, 22, 24, and 25 are representative of the appealed subject matter and read as follows (App. Br. 29-31; paragraphing added to claims 11and22): 11. An ophthalmic oil-in-water emulsion composition compnsmg: at least one oil selected from the group consisting of sesame oil, cherry kernel oil, pumpkin seed oil, hemp seed oil, flax seed oil, perilla seed oil, soybean oil, olive oil, canola oil, com oil, blackcurrant seed oil, cod liver oil, salmon oil, anchovy oil and tuna oil; a hydrophilic surfactant selected from the group consisting of polyethylene glycol esters of hydrogenated castor oil· ' a hydrophobic non-co-block surfactant selected from the group consisting of a polyoxyethylene(2) stearyl ether and a polyoxyethylene(2) oleyl ether; and water; and wherein said oil-in-water emulsion composition has an average particle size less than 1 µm in diameter. 22. ii:\.n ophthalmic oil=in=\'l/ater emulsion composition consisting essentially of: water; an oil selected from the group consisting of sesame oil, cherry kernel oil, pumpkin seed oil, hemp seed oil, flax seed oil, perilla seed oil, soybean oil, olive oil, canola oil, com oil, blackcurrant seed oil, cod liver oil, salmon oil, anchovy oil and tuna oil; a hydrophilic surfactant selected from the group consisting of polyethylene glycol esters of hydrogenated castor oil; and a hydrophobic non~co-block surfactant selected from the group consisting of from the group consisting of a polyoxyethylene(2) stearyl ether and a polyoxyethylene(2) oleyl ether wherein the composition has an average particle size of less than 0.6 µm. 3 Appeal2013-005893 Application 12/476,547 24. An ophthalmic oil-in-water emulsion composition consisting essentially of water, sesame oil, a polyethylene glycol ester of hydrogenated castor oil and a polyoxyethylene(2) oleyl ether, wherein the composition has an average particle size of less than 0.6 µm. 25. An ophthalmic oil-in-water emulsion composition consisting essentially of water, sesame oil, a polyethylene glycol ester of hydrogenated castor oil, a polyoxyethylene(2) stearyl ether or a polyoxyethylene(2) oleyl ether, and an amount of cyclosporine A effective to relieve dry eye symptoms, wherein the composition has an average particle size of less than 0.6 µm. The sole rejection before us for review is the Examiner's rejection of claims 1, 3---6, 8-11, 13-16, 18-20, 22, 24, and 25 under 35 U.S.C. § 103(a) for obviousness over Dor,3 Troyer,4 Weiner, 5 and Chang '710. 6 Final Action 6-9.7 OBVIOUSNESS The Examiner cited Dor as teaching therapeutic ophthalmic oil-in- water emulsions having nano-sized or micro-sized droplets of a solvent, thereby meeting the particle size limitations recited in the rejected claims. Final Action 7. The Examiner found that Dor taught also that its emulsions 3 U.S. Patent Appl. Pub. No. 2006/0182771 Al (published Aug. 17, 2006). 4 U.S. Patent No. 6,506,412 B2 (issued Jan. 14, 2003). 5 U.S. Patent No. 6,235,781 Bl (issued May 22, 2001). 6 U.S. Patent Appl. Pub. No. 2007/0015710 Al (published Jan. 18, 2007). 7 Although the Examiner did not include Chang '710 in the initial list of references, the Examiner relied on Chang '710 to show the obviousness of certain claimed features (see Final Action 7-8), and Appellant acknowledges the Examiner's reliance on Chang '710 (see App. Br. 5---6). 4 Appeal2013-005893 Application 12/476,547 could contain each of the ingredients recited in the claims, including cyclosporine A as the therapeutic agent, sesame oil as the solvent, hydrophilic surfactants with an HLB greater than 10, such as polyethoxylated hydrogenated castor oils, as well as hydrophobic surfactants with an HLB below 10. Id. The Examiner noted in particular that conventional surfactants disclosed in Dor include the hydrophobic "Brij type emulsifiers (HLB between 4 and 6) and [hydrophilic] Lumulse ® GRH-40 (HB value between 10 to 14)." Final Action 7 (citing Dor i-f 130). As further evidence that the claimed hydrophilic surfactants would have been suitable in the type of composition described in Dor, the Examiner cited Wiener as teaching "an eye drop composition preferably contains hydrogenated castor oil (with PEGs preferably between 25 and 50 i.e. Lumulse GRH-25)." Id. In addition, the Examiner found that an ordinary artisan would have been prompted to combine "Brij type surfactants with Lumulse surfactants and cyclosporine A, as the prior art (Chang ['710]) exemplifies cyclosporine A eye formulations which comprise Lumulse and Brij in combination with vegetable oils used for the very same purpose (i.e. eye drops)." Id. at 7-8. Therefore, the Examiner concluded, "it would have been prima facie obvious to formulate a composition comprising cyclosporine A, Brij 93 and Lumulse GRH-25." Id. at 8. The Examiner also found, as to some of the claimed embodiments, that Dor differed from the rejected claims in not disclosing fish oil or flaxseed oil as the oil solvent, and cited Troyer to show the obviousness of including those oils in dry eye-treating compositions encompassed by Dor. See id. at 7-8. 5 Appeal2013-005893 Application 12/476,547 In traversing the Examiner's rejection, Appellant states that, "[t]or the purposes of this appeal, claims 1, 3---6, 8-11, 13-16 and 18-20 stand or fall together, and claims 22, 24 and 25 each stand alone." App. Br. 6. We select claim 11 as representative of the first group of claims. 37 C.F.R. § 41.37(c)(l)(iv). As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prim a facie case of unpatentability .... After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. Appellant's arguments do not persuade us that a preponderance of the evidence fails to support the Examiner's prima facie case as to claim 11. In addition, for the reasons discussed below, we are not persuaded that Appellant has advanced evidence of unexpected results sufficient to outweigh the evidence of prima facie obviousness. Claim 11 recites an ophthalmic oil-in-water emulsion composition that, in addition to water, includes three ingredients: (1) an oil which may be sesame oil, (2) a hydrophilic surfactant which must be a polyethylene glycol ester of hydrogenated castor oil, and (3) a hydrophobic non-co-block surfactant which must be either a polyoxyethylene(2) stearyl ether or a polyoxyethylene(2) oleyl ether. App. Br. 29. Dor describes self-emulsifying formulations useful for topically treating a variety of eye disorders, including dry eye. Dor i-fi-130, 39, 77. Dor discloses that its self-emulsifying formulations may include "a therapeutic agent, a solvent, and a surfactant. The surfactant component 6 Appeal2013-005893 Application 12/476,547 may comprise a single surfactant or a combination of surfactants. The solvent component may comprise a single solvent or a combination of solvents." Id. i-f 43. As the Examiner found, and as encompassed by claim 11, Dor discloses sesame oil as a solvent for solubilizing the therapeutic agent (id. i-f 113), and hydrophilic surfactants with an HLB greater than 10, including polyethoxylated hydrogenated castor oil (id. i-f 128). As the Examiner also found, Dor discloses that hydrophobic surfactants with an HLB below 10 may be used in its compositions, "optionally ... in combination with other surfactants as co-surfactants." Id. i-f 132. As the Examiner found, Dor discloses that Brij type emulsifiers are suitable in its compositions. Id. ,-r 130. While it might be true that Dor does not expressly describe using precisely the hydrophobic surfactants recited in claim 11 in its formulations, as the Examiner pointed out, when preparing oil-containing formulations for treating dry eye (Chang '710 i-f 1, 11), Chang '710 teaches that Brij 78, a hydrophobic polyoxyethylene stearyl ether surfactant undisputedly encompassed by claim 11, was a suitable surfactant (id. i-f 1594). As the Examiner also pointed out, Weiner discloses that polyethoxylated hydrogenated castor oils were known in the art to be useful surfactants in topically applied ophthalmic compositions. Weiner, col. 4, 11. 39---63. Given the cited references' teachings, that each of the ingredients required by claim 11 was known in the art to be useful in topically applied ophthalmic oil-in-water emulsions, and that combinations of surfactants were useful in such formulations, we find that a preponderance of the evidence supports the Examiner's contention that an ordinary artisan would 7 Appeal2013-005893 Application 12/476,547 have considered it obvious to combine the claimed agents for use in such topically applied ophthalmic emulsions. As to the particle size required by claim 11, as the Examiner found, Dor teaches that, in such formulations, the "droplets in the emulsion may generally be of any size, including but not limited to those up to 5,000 nm." Dor i-f 31; see also id. at i-f 42 ("The droplets in the emulsion may generally be of any size. Emulsions formed by the self-emulsifying formulation may be of any type, including but not limited to micro- and nano-emulsions.") (emphasis added). Given these teachings, we also agree with the Examiner that an ordinary artisan would have considered it obvious to prepare these formulations with an average particle (oil droplet) size of less than 1 µm, as recited in claim 11. Accordingly, because the cited prior art suggests that the combination of ingredients recited in claim 11 would be useful in topically applied ophthalmic oil-in-water emulsions, and that the claimed average particle size would be suitable for such formulations, we find that a preponderance of the evidence supports the Examiner's prima facie case of obviousness as to claim 11. Appellant's arguments do not persuade us to the contrary. We acknowledge, as Appellant argues (App. Br. 9-14; Reply Br. 2---6), that claim 11 's solvent, surfactants, and active agent, appear as single items in long lists in Dor, and also in Chang '710. As our reviewing court has explained, however, that the prior art "discloses a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior 8 Appeal2013-005893 Application 12/476,547 art." Merck & Co. Inc. v. Biocrajt Labs. Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Thus, that the ingredients in claim 11 's composition were known in the prior art to be among many other useful alternatives included in topically applied therapeutic ophthalmic emulsions does not persuade us that an ordinary artisan lacked motivation to select those ingredients, particularly given the teachings, discussed above, that the specific ingredients recited in claim 11 were known to be useful in topically applied therapeutic ophthalmic emulsions. Moreover, given that the motivation for combining the ingredients recited in claim 11 would have been derived only from the prior art, Appellant's arguments (App. Br. 16-17; Reply Br. 4--5), do not persuade us that the Examiner's prima facie case is based improperly on hindsight. We acknowledge our reviewing court's interpretation of the fact situation in KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398 (2007), as "posit[ing] a situation with a finite, and in the context of the art, small or easily traversed, number of options that would convince an ordinarily skilled artisan of obviousness." Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358, 1364 (Fed. Cir. 2008) (emphasis added). In the context of the art involved in this case, topically applied therapeutic ophthalmic oil-in-water emulsions, the prior art recognizes that numerous different active agents, numerous different oil solvents, and numerous different surfactants are useful in such formulations, as evidenced by Dor and Chang '710, discussed above. That an ordinary artisan on the relevant date had many useful options from which to choose when preparing such a formulation does not persuade us that choosing a particular set of 9 Appeal2013-005893 Application 12/476,547 known useful options would have been unobvious, absent some showing that the resulting combination had properties that would not have been expected. See KSR, 550 U.S. 398 at 417 ("[W]hen a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious.") (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273 (1976)). Taken to its logical extension, Appellant's interpretation of Ortho- McNeil would mean that in an art such as this, which recognizes numerous suitable alternative ingredients, no formulation composed of known useful ingredients could be considered obvious under§ 103, absent some emphasis in the art of the formulation's particular ingredients, such as an expressed preference or disclosure of working examples. As our reviewing court has pointed out, however, "in a section 103 inquiry, the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered." Merck v. Biocraft, 874 F.2d at 807 (internal quotations omitted); see also In re Mills, 470 F.2d 649, 651 (CCPA 1972) ("All the disclosures in a reference must be evaluated, including nonpreferred embodiments, and a reference is not limited to the disclosure of specific working examples." (citations omitted)). Indeed, we note that in Merck v. Biocraft the court concluded that the claimed combination was obvious, despite the fact that the obviating reference disclosed a "multitude of effective combinations," and despite the fact that there was no emphasis on the claimed combination at issue. 87 4 F. 2d at 807. 10 Appeal2013-005893 Application 12/476,547 Appellant's arguments (App. Br. 15-17; Reply Br. 2) also do not persuade us that, under Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352 (Fed. Cir. 2011 ), all obviousness determinations relating to pharmaceutical compositions must proceed from an identified reference composition. As the court explained in that decision, the reference composition analysis is appropriate only in certain infringement contexts, which are not applicable here: In the context of a composition or formulation patent where the patented formulation was made to mimic a previously FDA- approved formulation, the functional and pharmaceutical properties of the "lead compound" can be more relevant than the actual chemical structure (though not always mutually exclusive). Thus, the term "reference composition" is more appropriate than "lead compound" when considering obviousness for a chemical composition that the infringer deliberately imitates. Unigene, 655 F.3d at 1361---62 (emphasis added). As to Appellant's argument that Troyer uses its fish oil in orally administered compositions, rather than the topical compositions of Dor and the other references (App. Br. 11; Reply Br. 5), we note that, in addition to fish oil, claim 11 recites sesame oil in its compositions (App. Br. 29). As discussed above, Appellant does not persuade us that the Examiner erred in finding that an ordinary artisan would have considered it obvious to include sesame oil in Dor's compositions. As to Appellant's argument that Weiner uses polyethylene glycol esters of hydrogenated castor oil in topical ophthalmic compositions for solubilizing prostaglandins and preventing the prostaglandins from adhering to container walls (App. Br. 13), Weiner, like Dor, nonetheless supports the 11 Appeal2013-005893 Application 12/476,547 Examiner's finding that the hydrophilic surfactants recited in claim 11 were known in the art to be suitable for use in solubilizing therapeutic agents in topical ophthalmic compositions. Appellant's arguments (App. Br. 14) also do not persuade us that the Examiner erred in finding that Dor suggests preparing therapeutic topical ophthalmic oil-in-water emulsions with a particle (oil droplet) size of less than 1 µm as recited in claim 1. Appellant "respectfully submits that these very brief statements [in i-fi-131 and 42 of Dor cited by the Examiner] regarding particle size do not provide one skilled in the art with sufficient guidance to render obvious the claimed range of less than 1 µm." Id. Appellant does not, however, explain with any specificity why Dor's express teaching of emulsion particle sizes of less than 5,000 nm, as well as micro- and nano-emulsions, both of which encompass particle sizes less than 1 µm, would have failed to direct an ordinary artisan to particles having a size encompassed by claim 11. Accordingly, we do not find Appellant's argument on this issue persuasive. In sum, for the reasons discussed, Appellant's arguments do not persuade us that a preponderance of the evidence fails to support the Examiner's prima facie case of obviousness as to claim 11. We are also unpersuaded that Appellant has advanced evidence of unexpected results sufficient to outweigh the evidence of prima facie obviousness. Specifically, Appellant contends that, as shown in the Specification, the inventor found it surprising that the total amount of free hydrophilic surfactant in the aqueous phase could be significantly reduced by combining a hydrophobic surfactant with a hydrophilic surfactant, and that reduction occurred only in the presence of a non-polar oil. App. Br. 15 (citing Spec. 12 Appeal2013-005893 Application 12/476,547 if 53). In particular, Appellant contends, Dor discloses using castor oil; "[a]ccordingly, one would not have expected the surprising benefits including a non-polar oil such as an oil recited in the instant claims, as compared to castor oil." Id. It is well settled, however, that "when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art." In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). In the instant case, in arguing that the reduction in the amount of hydrophilic surfactant was unexpected, Appellant does not identify which prior art embodiment is considered to be closest to claim 11. Nor does Appellant direct us to a specific comparison between a composition encompassed by claim 11 and a composition alleged to be the closest prior art. While we acknowledge Dor's disclosure the castor oil may be used as a solvent in its compositions (Dor if 108), Dor also discloses the suitability of claim 11 's sesame oil (id. if 113) as the solvent. Accordingly, it is not clear that a simple comparison between compositions containing castor and sesame oils would be an adequate comparison between claim 11 and the closest prior art. We note also that, despite the assertion that the claimed combination of ingredients results in an unexpected reduction in the required concentration of hydrophilic surfactant, thereby yielding a less eye-irritating composition, claim 11 does not contain any limitation on the concentration of the hydrophilic surfactant. See App. Br. 29. Accordingly, claim 11 encompasses concentrations of hydrophilic surfactant that would irritate the eye. We are not persuaded, therefore, that Appellant has established that the 13 Appeal2013-005893 Application 12/476,547 showing of unexpectedness it alleges is commensurate in scope with the claimed subject matter. See In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) ("[A]pplicant's showing of unexpected results must be commensurate in scope with the claimed range."). In sum, as discussed above, Appellant's arguments do not persuade us that a preponderance of the evidence fails to support the Examiner's prima facie case of obviousness as to claim 11. For the reasons discussed, we are also not persuaded that the evidence advanced by Appellant to show unexpected results is sufficient to outweigh the evidence of prima facie obviousness. Accordingly, we affirm the Examiner's obviousness rejection of claim 11. Because they were argued in the same claim grouping, claims 1, 3-6, 8-10, 13-16, and 18-20 fall with claim 11. 37 C.F.R. § 41.37(c)(l)(iv). As to claim 22, Appellant contends that claim is not obvious over the cited references for the same reasons discussed above, and further contends that an ordinary artisan would have not have arrived at a composition "consisting essentially of the recited components based on any of the cited references. Each of the references describes compositions that include components that may affect the basic and novel properties of the claimed compositions. To arrive at the compositions of claim 22, one would have needed to exclude such components." App. Br. 17. Appellant reiterates essentially the same argument as to claim 24. Id. at 18. We do not find these arguments persuasive. We note that claims 22 and 24 both recite compositions using the transitional phrase "consisting essentially of." App. Br. 30. We note also that "[b]y using the term 'consisting essentially of,' the drafter signals that the invention necessarily 14 Appeal2013-005893 Application 12/476,547 includes the listed ingredients and is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention." PPG Indus. Inc. v. Guardian Indus. Corp, 156 F.3d 1351, 1354 (Fed. Cir. 1998). Appellant, however, bears the burden of establishing that the ingredients present in the prior art composition are excluded by the "consisting essentially of' claim language. In re De Lajarte, 337 F.2d 870, 874 (CCPA 1964). In the instant case, Appellant does not advance any clear or specific evidence supporting its assertion that non-claimed ingredients in the compositions of the prior art affect the basic and novel properties of the compositions recited in claims 22 and 24. Nor does Appellant identify any specific ingredient in any of the cited prior art that would affect the basic and novel properties of the compositions recited in claims 22 and 24. Accordingly, Appellant's arguments do not persuade us that that the Examiner erred in concluding that the compositions recited in claims 22 and 24 would have been obvious to an ordinary artisan. We, therefore, affirm the Examiner's rejection of claims 22 and 24. Claim 25 recites an ophthalmic oil-in-water emulsion composition "consisting essentially of' five ingredients: (1) water, (2) sesame oil, (3) a polyethylene glycol ester of hydrogenated castor oil, (4) a polyoxyethylene(2) stearyl ether or a polyoxyethylene(2) oleyl ether, and (5) an amount of cyclosporine A effective to relieve dry eye symptoms. App. Br. 30-31. The claimed composition has an average particle size of less than 0.6 µm. Id. at 31. Claim 25, thus, adds cyclosporine A in a dry eye- treating amount, to the ingredients recited in claim 11 discussed above, as well as requiring a smaller average particle size. 15 Appeal2013-005893 Application 12/476,547 As noted above, and as the Examiner found, Dor teaches that its formulations can include cyclosporine A. Dor i-f 65. As also noted above, Chang '710 discloses the use of cyclosporine A as the active agent in oil- containing formulations for treating dry eye (Chang '710 i-f 1, 11), and also teaches that Brij 78, a hydrophobic polyoxyethylene stearyl ether surfactant undisputedly encompassed by claim 25, was a suitable surfactant in such compositions (id. i-f 1594). Given the cited references' teachings that each of the claimed ingredients was useful in a dry eye-treating topical ophthalmic composition, we find that a preponderance of the evidence supports the Examiner's conclusion that an ordinary artisan would have considered it obvious to include the claimed ingredients, including cyclosporine A, in a such a composition. Accordingly, we find that a preponderance of the evidence supports the Examiner's prima facie case as to claim 25. Appellant's arguments do not persuade us to the contrary. As to Appellant's arguments regarding the "consisting essentially of' language in claim 25 (App. Br. 18), Appellant does not advance any clear or specific evidence supporting its assertion that non-claimed ingredients in the compositions of the prior art affect the basic and novel properties of the composition recited in claim 25, nor does Appellant identify any specific ingredient in any of the cited prior art that would affect the basic and novel properties of the composition recited in claim 25. As to Appellant's arguments that Dor discloses cyclosporine A as a single member of a long list of therapeutic agents, and focuses on rapamycin as the active agent (App. 18-26), we first note, as indicated above, that Chang '710 not only discloses cyclosporine A as a suitable agent for treating dry eye in the type of formulation described in Dor, but also discloses 16 Appeal2013-005893 Application 12/476,547 cyclosporine A in combination with one of the claimed surfactants. Chang '710 ,-r 1594. For the reasons discussed above, moreover, that cyclosporine is one of a large number of possible combinations of ingredients described in Dor as being suitable for use in topical ophthalmic compositions does not persuade us that the Examiner erred in concluding that the particular combination recited in claim 25 would have been obvious to an ordinary artisan. See Merck v. Biocraft, 874 F.2d at 807 (That the prior art "discloses a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art."). Accordingly, because Appellant's arguments do not persuade us that a preponderance of the evidence fails to support the Examiner's conclusion that the composition recited in claim 25 would have been obvious to an ordinary artisan, we affirm the Examiner's rejection of that claim. SUMMARY For the reasons discussed, we affirm the Examiner's rejection of claims 1, 3---6, 8-11, 13-16, 18-20, 22, 24, and 25 under 35 U.S.C. § 103(a) for obviousness over Dor, Troyer, Weiner, and Chang '710. 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 17 Copy with citationCopy as parenthetical citation