10267013 (B.P.A.I. Sep. 2, 2010)

Ex Parte Johnson et al

Board of Patent Appeals and InterferencesSep 2, 2010

10267013 (B.P.A.I. Sep. 2, 2010)

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. 10/267,013 10/08/2002 Keith A. Johnson 1950.RESP.NP 7212 27472 7590 09/02/2010 BATEMAN IP LAW GROUP P.O. BOX 1319 SALT LAKE CITY, UT 84110 EXAMINER YU, JUSTINE ROMANG ART UNIT PAPER NUMBER 3771 MAIL DATE DELIVERY MODE 09/02/2010 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 KEITH A. JOHNSON, ROBERT A. CASPER and DAVID L. GARDNER ____________________ Appeal 2009-008649 Application 10/267,013 Technology Center 3700 ____________________ Before LINDA E. HORNER, WILLIAM F. PATE, III, and FRED A. SILVERBERG, Administrative Patent Judges. SILVERBERG, Administrative Patent Judge. DECISION ON APPEAL1 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 2009-008649 Application 10/267,013 2 STATEMENT OF THE CASE Keith A. Johnson et al. (Appellants) seek our review under 35 U.S.C. § 134 of the final rejection of claims 7-21, 40-55, 57-61 and 63-78. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE, and ENTER A NEW GROUND OF REJECTION PURSUANT TO 37 C.F.R. § 41.50(b). THE INVENTION Appellants’ claimed invention is directed to a drug delivery system for a combination of medicaments for use in inhalators (Spec. 2: para. [0002]). Claim 7, reproduced below, is representative of the subject matter on appeal. 7. An inhalation blister pack for delivering medicine for inhalation, the blister pack comprising at least two blisters containing different medicines, the medicines being configured for inhalation and being selected from the group consisting of powders, microcapsules and microspheres. THE REJECTION The following rejection by the Examiner is before us for review: Claims 7-21, 40-55, 57-61 and 63-78 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Widerstrom (6,698,425 B1, issued Mar. 2, 2004) in view of Wittwer (4,738,817, issued Apr. 19, 1988) ISSUE The issue before us is whether the Examiner erred in concluding that the combined teachings of Widerstrom and Wittwer would have led a person having ordinary skill in the art to a blister pack comprising blisters Appeal 2009-008649 Application 10/267,013 3 containing different medicines, as called for in independent claims 7, 40 and 41 (Reply Br. 5; App. Br. 9, 16, 18). ANALYSIS Appellants contend that the combined teachings of Widerstrom and Wittwer do not describe blisters having different medicines therein, as called for in independent claims 7, 40 and 41 (Reply Br. 5; App. Br. 9, 16, 18). We agree with the Examiner’s findings that Widerstrom describes a blister pack for delivering inhalation medicine, but does not describe blisters containing different medicines (Ans. 3). The Examiner found that Wittwer describes “blisters used in delivering medicines with different medicaments in different blisters.” In support thereof, the Examiner cites to Wittwer’s Figures 100-105 (Ans. 3). The Examiner, relying on Wittwer’s Figures 100-105, concluded that it would have been obvious to a person having ordinary skill in the art to modify the blister of Widerstrom to have different medicaments in different blisters as taught by Wittwer (Ans. 3). In Figures 100-105 of Wittwer, the blisters are filled with medicaments, and in Figures 100 and 101, a blister sheet 120 has separate blister compartments 121-124 (col. 18, ll. 53-65). In Wittwer, Figures 102- 105 show alternative embodiments of the capsule blister package (col. 19, ll. 4-6). In the embodiment shown in Wittwer’s Figures “104 and 105, the capsule blister package is shown with each compartment 121, 122 subdivided into subunits 127, 128, 129, 130, for containing different medicaments therein.” (Col. 19, ll. 12-15; see also col. 18, l. 45-col. 19, l. 11). Appeal 2009-008649 Application 10/267,013 4 Thus, Wittwer’s Figures 104 and 105 describe an alternate embodiment wherein the two subunits in each blister contain different medicaments. While Wittwer’s subunits in each blister would contain different medicaments, we find that each blister would have the same medicaments, that is, the same two medicaments, wherein a first medicament would be contained in the first subunit and a second medicament would be contained in the second subunit. Therefore, Wittwer’s Figures 100-105 do not describe blisters containing different medicaments, as found by the Examiner. Accordingly, the Examiner’s conclusion of obviousness is based upon the Examiner’s flawed finding in Wittwer. Thus, we are constrained to reverse the rejection of independent claims 7, 40 and 41. Likewise, we are constrained to reverse the rejection of claims 8-21, 42-55, 57-61 and 63-78 which depend from claims 7, 40 and 41, respectively. NEW GROUND OF REJECTION We enter a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). Claims 7, 40 and 41 Claims 7, 40 and 41 are rejected under 35 § U.S.C. 103(a) over Widerstrom in view of Wittwer. Claims 7 and 40 call for, inter alia, blisters containing different medicines, while Claim 41 calls for, inter alia, blisters containing different medicines, wherein the blisters are disposed in an alternating arrangement. Appeal 2009-008649 Application 10/267,013 5 Widerstrom describes a blister pack 2 for delivering inhalation medicine consisting of powder, a cutting means 7, 16 for opening multiple blisters, and a mouthpiece 12 for administering the medicine (col. 4, ll. 38- 47; col. 5, ll. 15-48; and figs. 1a, 6, 7, 9a, 9b). Widerstrom does not describe blisters containing different medicines. Widerstrom discloses that its inhalers are not limited to use with elongate blister packs and can be used with “[a]ny other layout of blisters.” Widerstrom, col. 6, ll. 51-54. Widerstrom further discloses that it was known in the art that such inhalers could be used to dispense many different types of medicaments. Widerstrom, col. 2, ll. 23-29. Wittwer describes in column 18, lines 45-52 the following: [a]nother embodiment of the capsule package for the combination of two different medicaments is shown in FIGS. 98 and 99, which show a plurality of capsule bodies 101 and caps 102 which are formed simultaneously by die-molding. The bodies 101 are connected while the caps 102 are not. The capsules are shown as arranged in two rows so that the two medicaments can be filled in adjoining bodies. (Emphasis added). Thus, Wittwer describes having at least two blisters in a single blister pack, wherein the blisters contain different medicines. It would have been obvious to a person having ordinary skill in the art to modify the medicine contained in the blisters 4 of Widerstrom by providing a first blister 4 with a first medicine and a second blister 4 with a second medicine as taught by Wittwer in column 18, lines 45-52 and Figures 98 and 99. We find that providing Widerstrom with a first blister containing a first medicine and second blister containing a second medicine could have been reasonably predicted to yield the result of providing a single blister Appeal 2009-008649 Application 10/267,013 6 pack containing two different medicaments, which would thereby permit the opening of multiple blisters by cutting means 7, 16 (figs. 6, 7) and the administration of the two different medicines. See KSR, 550 U.S. at 417 (holding that “[i]f 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.”) Regarding claim 41, the patent specification does not assign or suggest a particular definition to the term “alternating arrangement.” Therefore, in determining the ordinary and customary meaning of the claim term “alternating arrangement” as viewed by a person of ordinary skill in the art, it is appropriate to consult a general dictionary definition of the word “alternate” for guidance. Comaper Corp. v. Antec, Inc., 596 F.3d 1343, 1348 (Fed. Cir. 2010). The ordinary meaning of the word “alternate” includes “every other : every second.” MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY (10th ed. 1996). We find that in Figures 98 and 99 of Wittwer, since the capsules are shown as arranged in two rows so that two medicaments can be filled in adjoining bodies (col. 18, ll. 45-52); the different medicaments are arranged in an alternating arrangement. Thus, it would have been obvious to a person having ordinary skill in the art to provide the different medicines in Widerstrom’s blisters 4 in an alternating arrangement as taught by Wittwer to allow the administration of two different medicines. Appeal 2009-008649 Application 10/267,013 7 Therefore, we conclude that the combined teachings of Widerstrom and the embodiment described in Figures 98 and 99 of Wittwer would have led a person having ordinary skill in the art to a blister pack comprising blisters containing different medicines, as called for in independent claims 7, 40 and 41. Claims 8-21, 42-55, 57-61 and 63-78 The Board of Patent Appeals and Interferences is a review body, rather than a place of initial examination. We have made a rejection above under 37 C.F.R. § 41.50(b). However, we have not reviewed claims 8-21, 42-55, 57-61 and 63-78 to the extent necessary to determine whether these claims are unpatentable over Widerstrom in view of Wittwer. We leave it to the instant Examiner to determine the appropriateness of any further rejections based on these references.2 CONCLUSION The Examiner has erred in concluding that the combined teachings of Widerstrom and Wittwer (Figures 100-105) would have led a person having ordinary skill in the art to a blister pack comprising blisters containing different medicines, as called for in independent claims 7, 40 and 41. DECISION The decision of the Examiner to reject claims 7-21, 40-55, 57-61 and 63-78 is reversed. 2 In any further prosecution on the application, the Examiner’s rationale should include articulated reasoning with rational underpinning and not be based upon conclusory statements, e.g., “that capsules are used in inhalation devices” (Ans. 6) and “such arrangement is a design consideration” (Ans. 7). See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Appeal 2009-008649 Application 10/267,013 8 Pursuant our authority under 37 C.F.R. § 41.50(b), we enter a new ground of rejection of independent claims 7, 40 and 41 under 35 U.S.C. § 103(a) as being unpatentable over Widerstrom in view of Wittwer (Figures 98 and 99). FINALITY OF DECISION This decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b) (2007). 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 Appellants, 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. . . . (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). See 37 C.F.R. § 1.136(a)(1)(iv) (2007). REVERSED; 37 C.F.R. § 41.50(b) Appeal 2009-008649 Application 10/267,013 9 mls BATEMAN IP LAW GROUP P.O. BOX 1319 SALT LAKE CITY, UT 84110