Ex Parte Chaudry et alDownload PDFBoard of Patent Appeals and InterferencesFeb 14, 201111037574 (B.P.A.I. Feb. 14, 2011) 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. 11/037,574 01/18/2005 Imtiaz Chaudry 048765/287266 6491 826 7590 02/14/2011 ALSTON & BIRD LLP BANK OF AMERICA PLAZA 101 SOUTH TRYON STREET, SUITE 4000 CHARLOTTE, NC 28280-4000 EXAMINER WESTERBERG, NISSA M ART UNIT PAPER NUMBER 1618 MAIL DATE DELIVERY MODE 02/14/2011 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 IMTIAZ CHAUDRY and PARTHA BANERJEE __________ Appeal 2010-005705 Application 11/037,574 Technology Center 1600 __________ Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and MELANIE L. McCOLLUM, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL1 This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). 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 2010-005705 Application 11/037,574 2 STATEMENT OF CASE The following claims are representative. 1. A system for inducing bronchodilation or providing relief of bronchospasm in an individual suffering from chronic obstructive pulmonary disease, said system comprising: (a) one or more single dispensing containers; and (b) an aqueous inhalation solution comprising a therapeutically effective amount of albuterol and a therapeutically effective amount of about 0.001 mg to about 1.0 mg of ipratropium bromide; wherein the aqueous inhalation solution is prefilled in each of the one or more dispensing containers as a premixed, premeasured, single unit dose of about 0.1 ml to about 0.5 ml that, when administered from a nebulizer chamber, is delivered such that the mist is removed from the nebulizer chamber in less than 12 minutes when said aqueous inhalation solution is introduced into a high performance nebulizer. 18. A method of inducing bronchodilation or providing relief of bronchospasm in an individual suffering from chronic obstructive pulmonary disease, said method comprising the step of: (a) providing one or more single dispensing containers; the one or more containers each being prefilled with a content of about 0.1 ml to about 0.5 ml of a premixed, premeasured aqueous inhalation solution comprising a single unit dose of a therapeutically effective amount of albuterol and ipratropium bromide; wherein the amount of albuterol is about 0.6 mg to about 5.0 mg and the amount of ipratropium bromide is about 0.1 mg to about 1.0 mg; and (b) administering the inhalation solution in one of the containers from a nebulizer chamber such that the mist is removed from the nebulizer chamber in less than 12 minutes. 49. A system for inducing bronchodilation or providing relief of bronchospasm in an individual suffering from chronic obstructive pulmonary disease, said system comprising: (a) one or more single dispensing containers; and (b) an aqueous inhalation solution comprising a therapeutically effective amount of albuterol and a therapeutically effective amount of about 0.001 mg to about 1.0 mg of ipratropium bromide; Appeal 2010-005705 Application 11/037,574 3 wherein the aqueous inhalation solution is prefilled in each of the one or more dispensing containers as a premixed, premeasured, single unit dose of about 0.1 ml to about 0.5 ml. Cited References COMBIVENT® product information sheet, 1997. The COMBIVENT Inhalation Solution Study Group (Chest 1997), Routine Nebulized Ipratropium and Albuterol Together Are Better Than Either Alone in COPD, 112 CHEST 1514-1521 (1997). Tandon et al., Measuring Nebulizer Output: Aerosol Production vs Gravimetric Analysis, 111 CHEST 1361-1365 (1997). Allan L. Coates and Sharon L. Ho, Drug Administration by Jet Nebulization, 26 PEDIATRIC PULMONOLOGY 412-423 (1998). Asmus et al, Bronchoconstrictor additives in bronchodilator solutions, 104 J. ALLERGY CLIN. IMMUNOL. S53-60 (1999). Grounds of Rejection 1. Claims 1, 4-11 and 49 are rejected under 35 U.S.C. § 103(a) for obviousness over Combivent in view of Asmus and Coates. 2. Claims 1, 4-11, 18, 21, 22, 30-33 and 38-49 are rejected under 35 U.S.C. § 103(a) for obviousness over Chest 1997 in view of Asmus and Coates. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 3-8. Appeal 2010-005705 Application 11/037,574 4 Discussion 1. Claims 1, 4-11 and 49 are rejected under 35 U.S.C. § 103(a) for obviousness over Combivent in view of Asmus and Coates. ISSUE The Examiner concludes that It would have been obvious to one of ordinary skill in the art at the time of the instant invention to reduce the total volume of the single unit dose Combivent® respule, comprising 2.5 mg of albuterol and 0.5 mg of ipratropium bromide, to reduce the volume of the solution that must be delivered that contains the same total dose of albuterol and ipratropium bromide as Coates et al. discloses that long nebulization times can result in decreased patient compliance. Decreasing the volume of the solution to be nebulized will result in shorter treatment durations, as lesser volumes will require less time to be nebulized and inhaled. As long nebulization times decrease patient compliance, shorter nebulization times would tend to increase patient compliance. The volume of the solution is a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal volume to deliver the active ingredients in order to best achieve the desired results, such as the level of patient compliance that results from the overall length of the nebulization treatment. (Ans. 4-5.) The Examiner finds that the delivery time for the solution in the system claims is intended use language which does not further limit the product of the claims. (Id. at 5.) Appeal 2010-005705 Application 11/037,574 5 Appellants argue that the Examiner has not set forth a prima facie case of obviousness. (App. Br. 5.) Appellants argue that one of ordinary skill in the art would not combine teachings around multidose forms of drug with teachings around unit dosage forms. (Id. at 6-7.) Appellants argue that no further dilution of the drug is required with the claimed system. (Id. at 11.) Appellants argue that Coates does not suggest that nebulization times should be decreased and teaches away from reduced nebulization volumes. (Id. at 9, 13.) The issue is: Does the cited prior art disclose or suggest a dispensing container prefilled with about 0.1 ml to about 0.5 ml of an aqueous inhalation solution, as claimed? PRINCIPLES OF LAW “In rejecting claims under 35 U.S.C. § 103, the examiner bears the initial burden of presenting a prima facie case of obviousness. Only if that burden is met, does the burden of coming forward with evidence or argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993) (citations omitted). In order to determine whether a prima facie case of obviousness has been established, we consider the factors set forth in Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content of the prior art; (2) the differences between the prior art and the claims at issue; (3) the level of ordinary skill in the relevant art; and (4) objective evidence of nonobviousness, if present. In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court advised that, in determining whether the prior art supplied a reason for practicing the claimed subject matter, the analysis “need not seek out precise Appeal 2010-005705 Application 11/037,574 6 teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418; see also id. at 421 (“A person of ordinary skill is . . . a person of ordinary creativity, not an automaton.”). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. at 416. If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at 417. In KSR, the Supreme Court also addressed the “obvious to try” issue: When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103. Id. at 421. Appeal 2010-005705 Application 11/037,574 7 One “of the ways in which a patent’s subject matter can be proved obvious is by noting that there existed at the time of the invention a known problem for which there was an obvious solution encompassed by the patent’s claims.” Id. at 419-20. “A whereby clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim.” Texas Instuments v. U.S. Int’l Trade Comm’n, 988 F.2d 1165, 1172 (Fed. Cir. 1993). ANALYSIS Claims 1 and 49 We begin with claim interpretation. Claims 1 and 49 are directed to a system or product with one or more containers and an aqueous inhalation solution comprising a therapeutically effective amount of albuterol and a therapeutically effective amount of about 0.001 mg to about 1.0 mg of ipratropium bromide, wherein the inhalation solution is prefilled in each of the one or more containers as a dose of about 0.1 ml to about 0.5 ml. We agree with the Examiner that the delivery time for the solution in the system claim 1 is intended use language that does not further limit the product of the claims (Ans. 5). In addition, we do not agree with Appellants that the language in claims 1 and 49 describing the dose as “a premixed, premeasured, single unit dose” excludes doses that are subsequently diluted, as this would give unjustified patentable weight to an intended use of a product. Appellants argue that the Examiner has not set forth a prima facie case of obviousness. (App. Br. 5.) Appellants argue that one of ordinary skill in Appeal 2010-005705 Application 11/037,574 8 the art would not combine teachings around multidose forms of drug with teachings around unit dosage forms. (App. Br. 6-7.) Appellants argue that no further dilution of the drug is required with the claimed system. (Id. at 11.) Appellants argue that Coates does not suggest that nebulization times should be decreased and teaches away from reduced nebulization volumes. (Id. at 9, 13.) With respect to system claims 1 and 49, we are not persuaded by Appellants’ arguments. As to the Examiner’s prima facie case of obviousness, Combivent teaches the claimed combination of albuterol and ipratroprum bromide for use in a nebulizer. (Combivent, page 1; Ans. 3.) Combivent teaches 2.5 mg of albuterol and 500 mcg of ipratropium bromide. Asmus teaches that it is known to include 2.5 mg of albuterol in a total volume of 0.5 ml and single dose products in table 2. (Ans. 4.) Thus, Combivent and Asmus suggest the desirability of placing smaller, concentrated volumes of albuterol, 0.5ml, and ipratropium bromide in containers. While Appellants argue that it is well recognized that concentrated volumes of drug are diluted for delivery by nebulization (App. Br. 10), appealed claims 1 and 49 do not exclude dilution of the volumes in the containers. Appellants argue that Coates teaches away from reduced nebulization times (id. at 13). Appellants argue that Coates teaches increasing the charge volume of a given dose, which dilutes the concentration of the initial dose (id. at 14.) Again, claims 1 and 49 do not exclude dilution of a dosage container. For the reasons addressed in the claim interpretation above, we Appeal 2010-005705 Application 11/037,574 9 do not agree that the product of claims 1 and 49 excludes solutions that are subsequently diluted. Appellants argue that one of ordinary skill in the art would not combine teachings around multidose forms of drug with teachings around unit dosage forms. We are not convinced by this argument. Appellants have provided no evidence that one of ordinary skill in the art would not understand, as taught in Asmus, that albuterol can be formulated either in multidose or unit dosage forms. (Ans. 10.) Claims 7 and 8 Appellants argue that the cited prior art does not disclose or suggest the subject matter of claims 7 and 8 which recite that the inhalation solution is sterile and that the inhalation solution is free of the preservative benzalkonium chloride, BAC. (App. Br. 19.) Asmus discloses that preservatives such as benzalkonium chloride should not be included in formulations as they can cause bronchoconstriction. (Asmus, S55, col. 2.) Asmus discloses that bronchodilator solutions are manufactured as sterile solutions and that the FDA has proposed that all such solutions be sterile. Thus the prior art discloses a reason to provide sterile bronchodilator solutions free of BAC. The rejection of claims 7and 8 is affirmed. For these reasons, the obviousness rejection is affirmed. Appeal 2010-005705 Application 11/037,574 10 2. Claims 1, 4-11, 18, 21, 22, 30-33 and 38-49 are rejected under 35 U.S.C. § 103(a) for obviousness over Chest 1997 in view of Asmus and Coates. The Examiner additionally rejects the pending claims indicated over Chest 1997 in view of Asmus and Coates, essentially substituting the Chest 1997 publication for the same teachings as Combivent. Thus, for the reasons indicated above, the rejection of claims 1 and 49 and their dependent claims are affirmed. However, method claim 18 stands on a different footing than system claims 1 and 49. The method of claim 18 requires a step of “(b) administering the inhalation solution in one of the containers from a nebulizer chamber” (emphasis added). We interpret this language to require that the claimed volume of about 0.1 to about 0.5 ml is, without dilution, administered from a nebulizer chamber. Appellants argue that Coates teaches away from reduced nebulization volumes. (App. Br. 9, 13.) The Examiner argues that Coates teaches that long nebulization times can result in reduced patient compliance (Ans. 4) and that it would have been obvious to one of ordinary skill in the art to decrease the volume of the solution to be nebulized (id.). To the contrary, Coates, page 418, col. 1, discloses that, in a nebulizer, “aerosolized output can be increased for a given dose of drug by minimizing the concentrating effects of nebulization, and by increasing the charge volume, which dilutes the concentration of the initial dose, although it will prolong nebulization time.” The Examiner has pointed to no disclosure in Coates which suggests reducing the total nebulization volume in a nebulizer (App. Br. 14) and Coates teaches that charge volume should not be decreased, although it will prolong nebulization time. (Id.) Thus, Appeal 2010-005705 Application 11/037,574 11 when delivered in a nebulizer, as claimed, it would reasonably appear that Coates teaches that the charge volume of broncodilator solution should not be decreased. For this reason, the rejection of claim 18 and its dependent claims 21-22, 30-33 and 42-48 is reversed. CONCLUSION OF LAW Rejection 1 is affirmed. Rejection 2 is affirmed for claims 1, 4-11, 38-41, and 49. Rejection 2 is reversed as to claims 18, 21-22, 30-33 and 42- 48. With regard to the affirmed rejections, because our reasoning differs from that of the Examiner, we designate our affirmance as new grounds of rejection under 37 C.F.R. § 41.50(b) in order to give Appellants a fair opportunity to respond. TIME PERIOD FOR RESPONSE This decision 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 C.F.R. § 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 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 Appeal 2010-005705 Application 11/037,574 12 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. . . . (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record. . . . 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-IN-PART, 37 C.F.R. § 41.50(b) cdc ALSTON & BIRD LLP BANK OF AMERICA PLAZA 101 SOUTH TRYON STREET, SUITE 4000 CHARLOTTE, NC 28280-4000 Copy with citationCopy as parenthetical citation