Ex Parte TsaoDownload PDFBoard of Patent Appeals and InterferencesDec 13, 201010346013 (B.P.A.I. Dec. 13, 2010) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 10/346,013 01/16/2003 Fu-Pao Tsao OP/4-32320A 2897 1095 7590 12/13/2010 NOVARTIS CORPORATE INTELLECTUAL PROPERTY ONE HEALTH PLAZA 101/2 EAST HANOVER, NJ 07936-1080 EXAMINER FAY, ZOHREH A ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 12/13/2010 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte FU-PAO TSAO __________ Appeal 2010-010109 Application 10/346,013 Technology Center 1600 __________ Before TONI R. SCHEINER, FRANCISCO C. PRATS, and STEPHEN WALSH, Administrative Patent Judges. WALSH, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134(a) involving claims to a method of inhibiting Cladosporium growth in an aqueous opthalmic solution and to an ophthalmic solution. The Patent Examiner rejected the claims as 1 The two-month time period for filing an appeal or commencing a civil action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE” (paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery mode) shown on the PTOL-90A cover letter attached to this decision. Appeal 2010-010109 Application 10/346,013 2 obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. We also enter a new ground of rejection, exercising our authority under 37 C.F.R. § 41.50(b). STATEMENT OF THE CASE Claims 1-20 are on appeal. Claims 1 and 13 are representative and read as follows: 1. A method of inhibiting Cladosporium growth in an aqueous ophthalmic solution comprising a cellulose derivative and a hydrogen peroxide source, comprising: providing an aqueous solution comprising a cellulose derivative and a hydrogen peroxide source, wherein said solution will support Cladosporium growth if contaminated with Cladosporium; and admixing an effective amount of an alkaline earth metal salt with said solution to yield an alkaline earth metal-containing solution which, if contaminated with Cladosporium, will allow less Cladosporium growth than an otherwise identical solution that does not comprise an alkaline earth metal salt. 13. An ophthalmic solution comprising: (a) a hydrogen peroxide source (b) a cellulose derivative (c) water; and (d) an effective amount of an alkaline earth metal salt such that if said solution is contaminated with Cladosporium, less Cladosporium growth will occur in said solution than an otherwise identical solution that does not comprise an alkaline earth metal salt. The Examiner rejected all of the claims under 35 U.S.C. § 103(a) as unpatentable over Martin,2 Richard,3 and a Japanese Patent Abstract.4 2 US Patent No. 5,607,698 issued to Stephen M. Martin et al., Mar. 4, 1997. 3 US Patent No. 5,858,937 issued to Wanda G. Richard et al., Jan. 12, 1999. 4 JP60146807 A issued to Nippon Caloxide KK et al., Feb. 8, 1985. Appeal 2010-010109 Application 10/346,013 3 Claims 2-20 have not been argued separately and therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii). OBVIOUSNESS The Issue The Examiner’s position is that Martin taught the use of a hydrogen peroxide source, a hydrogen stabilizer, and a cellulose derivative in an ophthalmic solution. (Ans. 3.) The Examiner found that Martin differed from the claimed invention in the presence of an alkaline earth metal salt, for example, calcium chloride dehydrate. (Id.) The Examiner found that Richard taught an ophthalmic solution comprising an antimicrobial agent, phosphonic acid and an alkaline earth metal, i.e., calcium chloride. (Id.) Additionally, the Examiner found that the Japanese patent abstract taught the use of hydrogen peroxide as a fungicide in combination with hydroxyl propylcellulose and stabilizers, including phosphates. (Id. at 4.) According to the Examiner, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to have incorporated an alkaline earth metal salt into the composition of Martin, motivated by Richard’s teaching that the addition of an alkaline earth metal salt, such as calcium chloride dehydrate, to an ophthalmic solution with antimicrobial activity was old and well known. (Id.) The Examiner also reasoned that the prior art established that a hydrogen peroxide source, a stabilizer such as phosphonic acid, a cellulose derivative, and an alkaline earth metal salt previously had been used in an ophthalmic formulation. Appeal 2010-010109 Application 10/346,013 4 (Id.) Further, the Examiner found that Appellant had not presented evidence establishing that the claimed invention provided unexpected results. (Id.) Appellant contends that “there would have been no motivation to combine Richard, Martin and the Japanese Abstract as asserted by the Examiner….” (App. Br. 9-10.) According to Appellant, “there is no teaching in the prior art which would motivate one of skill in the art to arbitrarily select a ‘tonicity enhancer’ from Richard and employ it with the solution of Martin in quantities sufficient to impart enhanced Cladosporium inhibiting properties to said solution.” (Id. at 11.) Further, Appellant asserts that Richard taught away from using hydrogen peroxide in combination with its ingredients by teaching a “complete non-oxidative cleaning regime.” (Id. at 10.) Appellant also asserts that the Japanese Abstract represented non-analogous art because its teachings are directed to a fungicide for bathroom cleansers. (Id. at 11.) Additionally, Appellant asserts that each of the references failed to teach or suggest (a) a method of inhibiting Cladosporium growth, and (b) an ophthalmic solution which exhibits antifungal activity against Cladosporium. (Id. at 9-11.) The issue with respect to the rejection is whether the record supports the Examiner’s conclusion that the cited references would have made the claimed method and opthalmic solution prima facie obvious. Appeal 2010-010109 Application 10/346,013 5 Findings of Fact 1. We agree with the Examiner’s explicit findings regarding the scope and content of the prior art references. (See Ans. 3-4.) 2. Martin disclosed that hydrogen peroxide was a well-known germicidal agent for use in contact lens solutions to kill any contaminating microorganisms. (Martin, col. 1, ll. 19-23.) 3. Martin disclosed adding one or more tonicity agents to its stabilized hydrogen peroxide opthalmic solution. (Id. at col. 7, ll. 38-55.) 4. Martin taught that “[t]he function of such tonicity enhan[c]ing agents is to assure approximate physiological tonicity to the solution which is instilled in the eye or to help assure such tonicity upon dilution if dilution is necessary prior to contact with the eye due to peroxide content . . . .” (Id.) 5. Richard disclosed adding tonicity agent(s) to its ophthalmic solution, such as the alkaline earth metal salts calcium and magnesium chloride, in amounts ranging from about 0.01 to 2.5% w/v, and preferably from about 0.2 to about 1.5% w/v. (Richard, col. 7, ll. 1-18.) 6. Richard taught that the tonicity agents were used “to approximate the osmotic pressure of normal lacrimal fluids,” and that “a hypertonic solution . . . will cause stinging and eye irritation.” (Id. at col. 7, ll. 1-12.) 7. The Specification discloses using soluble alkaline earth metal salts in amounts between about 0.01 and 0.2% or 0.05 and 0.1% by weight of the preserved solution. (Spec. 3, ll. 23-27.) Principles of Law “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining Appeal 2010-010109 Application 10/346,013 6 the elements in the manner claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). As long as some suggestion to combine the elements is provided by the prior art as a whole, the law does not require that they be combined for the reason or advantage contemplated by the inventor. See e.g., In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992); In re Kronig, 539 F.2d 1300, 1304 (CCPA 1976). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR, 550 U.S. at 416. “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Analysis We agree with the Examiner that the claimed methods and opthalmic solutions would have been obvious over the combined art to a skilled artisan at the time of the invention. Specifically, adding an alkaline earth metal to the Martin’s stabilized hydrogen peroxide ophthalmic solution would have been obvious because Martin expressly disclosed adding one or more tonicity agents to its solution. (FF3.) As Appellant has aptly noted (App. Br. 11) Richard disclosed using alkaline earth metal salts, i.e., calcium or magnesium chloride, as effective tonicity agents in its contact lens solution. (FF5.) We find that a skilled artisan would have been motivated to select one of Richard’s tonicity agents as the tonicity agent in Martin’s solution. Doing so would have amounted to no more than the combination of familiar elements according to known methods. KSR, 550 U.S. at 416. Again, the reason for combining the elements of the prior art need not be the same Appeal 2010-010109 Application 10/346,013 7 contemplated by the inventor. Beattie, 974 F.2d at 1312; Kronig, 539 F.2d at 1304. The selection of one of Richard’s tonicity agents, and its substitution for one of the agents Martin listed, would have resulted in a solution having the function of the claimed invention, i.e., allowing less Cladosporium growth. Richard taught the addition of its tonicity agent(s) in amounts ranging from about 0.01 to 2.5% w/v (FF5) which overlaps the range of alkaline earth metal salts disclosed in the Specification, i.e., amounts between about 0.01 and 0.2% or 0.05 and 0.1% (FF5). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)( “[E]ven a slight overlap in range establishes a prima facie case of obviousness.”). Here, the claimed range for the amount of alkaline earth metal salt is encompassed by Richard’s amount. See id. at 1330 (where the “claimed ranges are completely encompassed by the prior art, the conclusion [that the claims are prima facie obvious] is even more compelling than in cases of mere overlap.”). We find that a skilled artisan would have expected the ophthalmic solutions of the combined prior art to have the same properties as those claimed. (Compare FF 4 and FF6.) Absent evidence of unexpected results, [t]he recitation that the claimed solution and method “will allow less Cladosporium growth …” does not change this result as it merely recognizes a latent property of an obvious prior art combination. See Baxter-Travenol Labs., 952 F.2d at 392. Put another way, addressing Martin’s tonicity problem with Richard’s tonicity agents would have resulted in an ophthalmic solution having the property Appellant recites. See KSR, 550 U.S. at 419-420 (“[o]ne of the ways in which a patent’s subject matter can be proved obvious is by noting Appeal 2010-010109 Application 10/346,013 8 that there existed at the time of invention a known problem for which there was an obvious solution encompassed by the patent’s claims.”). Appellant asserts that Richard taught away from using hydrogen peroxide in its solution (App. Br. 10), but we are not persuaded as the argument is misdirected. The Examiner’s combination did not require adding hydrogen peroxide to Richard’s composition. Rather, the combination involved using Richard’s disclosed alkaline metal salt tonicity agent as Martin’s tonicity agent. Nor are we persuaded of nonobviousness by Appellant’s assertion that the Japanese Abstract represents non-analogous art. (App. Br. 11.) The Examiner referenced the Abstract for its teaching that hydrogen peroxide was a known fungicide. (Ans. 4.) This teaching merely complements Martin’s teaching that hydrogen peroxide was a known germicidal agent. (FF2.) The Abstract was not relied upon to establish the safe or effective use of hydrogen peroxide in eye care, as this teaching was expressly understood from Martin’s disclosure. Therefore, we find that a skilled artisan would have considered the Examiner’s reference to the Abstract to be reasonably pertinent to the subject matter of the claimed invention. See In re Kahn, 441 F.3d 977, 986-87 (Fed. Cir. 2006). Although we affirm the obviousness rejection of claims 1-20 over the combination Martin, Richards, and the Japanese Patent Abstract, our reasoning differs from the Examiner’s reasoning. (See Ans. 4.) Accordingly, we designate the affirmance a new ground of rejection under 37 C.F.R. § 41.50 (b). Appeal 2010-010109 Application 10/346,013 9 CONCLUSION OF LAW The record supports the Examiner’s conclusion that the cited references would have made the claimed method and opthalmic solutions prima facie obvious. SUMMARY We affirm the rejection of claims 1-20 under 35 U.S.C. § 103(a) as unpatentable over Martin, Richards, and the Japanese Patent Abstract. 37 C.F.R. § 41.50(b) Regarding the affirmed rejections, 37 C.F.R. § 41.52(a)(1) provides “[a]ppellant may file a single request for rehearing within two months from the date of the original decision of the Board.” In addition to affirming the examiner's rejection(s) of one or more claims, this opinion contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR § 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner.… Appeal 2010-010109 Application 10/346,013 10 (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record.… Should the appellant elect to prosecute further before the examiner pursuant to 37 C.F.R. § 41.50(b)(1), in order to preserve the right to seek review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection, the effective date of the affirmance is deferred until conclusion of the prosecution before the examiner unless, as a mere incident to the limited prosecution, the affirmed rejection is overcome. If the appellant elects prosecution before the examiner and this does not result in allowance of the application, abandonment or a second appeal, this case should be returned to the Board of Patent Appeals and Interferences for final action on the affirmed rejection, including any timely request for rehearing thereof. AFFIRMED cdc NOVARTIS CORPORATE INTELLECTUAL PROPERTY ONE HEALTH PLAZA 101/2 EAST HANOVER, NJ 07936-1080 Copy with citationCopy as parenthetical citation