Ex Parte YuDownload PDFPatent Trial and Appeal BoardMay 17, 201612476579 (P.T.A.B. May. 17, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/476,579 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. 27799 5737 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 Appeal2013-005894 1 Application 12/476,5792 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 reverse. 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 12/476,547 (Appeal 2013-005894) and 12/476,600 (Appeal 2013-004196). App. Br. 3. Appeal2013-005894 Application 12/476,579 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 37. 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 48. 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 49. 2 Appeal2013-005894 Application 12/476,579 Claim 1 is illustrative of the appealed subject matter and reads as follows (App. Br. 28): 1. An ophthalmic oil-in-water emulsion composition comprising: an ophthalmically acceptable omega-3 fatty acid- containing oil, wherein the oil is from a botanical source selected from the group consisting of Chia, Kiwifruit, Perilla (shiso or Perilla frutescens), Flax seed, Lingonberry, Camelina, Purslane and Black Raspberry, or is an oil from cold water fish selected from the group consisting of 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 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. The sole rejection before us for review is the Examiner's rejection of claims 1, 3---6, 8-12, 14, and 15 under 35 U.S.C. § 103(a) for obviousness over Dor,3 Troyer,4 Chang '710,5 and Weiner. 6 Final Action 5-8. 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 6. The Examiner found that Dor taught also that its emulsions could contain a number of the ingredients recited in the claims, including cyclosporine A as the therapeutic agent, sesame oil as the solvent, 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 Appl. Pub. No. 2007/0015710 Al (published Jan. 18, 2007). 6 U.S. Patent No. 6,235,781 Bl (issued May 22, 2001). 3 Appeal2013-005894 Application 12/476,579 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 6 (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 oils (with the 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 the Lumulse and cyclosporine A of Dor et al. as the prior art (Chang ['710]) exemplifies cyclosporine A eye drop[s] which comprise Lumulse and Brij 93 in combination with vegetable oils used for the very same purpose." Id. at 6-7. 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 7. The Examiner conceded, however, 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 6-7. In particular, the Examiner reasoned, an ordinary artisan would have considered it obvious to add fish and flaxseed oils to Dor' s compositions, "motivated by the teachings of Troyer et al., which teaches the use of fish oil and flaxseed oil 4 Appeal2013-005894 Application 12/476,579 for the treatment of dry eye. It is prima facie obvious to combine the components being used for the same purpose." Id. at 7 (citing In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980)). Appellant argues, among other things, that none of the rejected claims recites sesame oil. App. Br. 10. Moreover, Appellant argues, rather than disclosing ophthalmic emulsions, Troyer discloses orally administered compositions which are described as including a particular combination of ingredients that is disclosed as being "uniquely effective in that specific combination. One skilled in the art would not have been motivated to select one particular component out of this combination, and use it in a completely different type of composition, such as an ophthalmic emulsion composition, with any reasonable expectation of success." Id. at 11. The Examiner responds: Troyer et al. teach flax seed oil and fish oil as a source of omega-3 fatty acids, which can be used for the treatment of dry eye. It \'l/ould have been obvious to a person skilled in the art to substitute flax seed oil and fish oil for the oils taught by Dor et al., considering that such oils are functionally equivalent and all have been used for the treatment of dry eye. Ans. 10. As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a primafacie case ofunpatentability .... 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. In the instant case, we are not persuaded that the preponderance of the evidence supports the Examiner's prima facie case of obviousness. Each of 5 Appeal2013-005894 Application 12/476,579 the independent claims on appeal, claims 1, 11, 12, 14, and 15, recites an ophthalmic oil-in-water emulsion that includes an oil component. App. Br. 28-30. While the Examiner directed us to Dor's disclosure of using sesame oil as the oil component in its composition (Final Action 6), none of claims 1, 11, 12, 14, and 15 recites sesame oil in the Markush group of ophthalmically acceptable omega-3 fatty acid-containing oils, as Appellant contends (App. Br. 10). We acknowledge Troyer's disclosure that dry eye-treating compositions can include cod liver oil, recited in claims 1, 11, and 12, as a source of omega-3 fatty acids in a dry eye-treating formulation. Troyer, col. 2, 1. 66 through col. 3, 1. 19; col. 4, 11. 56-64. We acknowledge also Troyer's disclosure that omega-3 fatty acids useful in its compositions are also found in flaxseed, the oil source recited in claims 14 and 15. Id. at col. 3, 11. 65---67. As Appellant contends, however, Troyer discloses an orally-administered preparation [that] comprises a unique combination of biologically active ingredients. The preparation does not merely treat symptoms of dry eye, as do prior topical lubricating products or hypotonic solutions and mucolytic agents that can decrease symptoms of excess mucin strands, or other additives that can help lower tension at the water-oil interfaces and mimic some actions of mucin network. The treatment according to the invention addresses the underlying causes of dry eye syndrome, rather than providing temporary palliative measures. Id. at col. 2, 11. 32--42 (emphasis added). Troyer, thus, expressly distinguishes its orally administered compositions from topically applied solutions. 6 Appeal2013-005894 Application 12/476,579 In contrast, as the Examiner found, Chang '710's dry eye-treating compositions are topically applied (Chang '710 i-f 5901 ), as are the compositions described in Weiner (see Weiner, col. 6, 1. 7 through col. 11, 1. 48). Dor's ophthalmic emulsions are also topically applied (see, e.g., Dor, abstract), and the Examiner's rationale for combining the references is for the common purpose of making dry eye-treating eye drops (see Final Action 6-7). We agree with Appellant that the Examiner has not adequately explained why an ordinary artisan would have been prompted to include the fish oil and flaxseed, used in the orally administered nutritional supplement described in Troyer, in the topically applied eye drop emulsions described in the remaining references. In particular, we are not persuaded that the Examiner has advanced a clear or specific rationale that adequately explains why an ordinary artisan would have considered oils, used as nutritional supplements in orally administered compositions, to be functional equivalents to oils used as solvents for solubilizing therapeutic agents in topically applied ophthalmic emulsions. Nor has the Examiner advanced any clear or specific evidence supporting that assertion. Nor has the Examiner advanced any clear or specific evidence suggesting that either fish oil or flaxseed oil was known to be an ophthalmically acceptable topical excipient. Accordingly, because we are not persuaded that the Examiner has adequately explained why an ordinary artisan would have prepared compositions having all of the ingredients required by claims 1, 11, 12, 14, and 15, the independent claims on appeal, we reverse the Examiner's rejection of those claims as well as their dependent claims. 7 Appeal2013-005894 Application 12/476,579 SUMMARY For the reasons discussed, we reverse the Examiner's rejection of claims 1, 3---6, 8-12, 14, and 15 under 35 U.S.C. § 103(a) for obviousness over Dor, Troyer, Chang '710, and Weiner. REVERSED 8 Copy with citationCopy as parenthetical citation