Ex Parte 7562656 et alDownload PDFPatent Trial and Appeal BoardDec 13, 201395001216 (P.T.A.B. Dec. 13, 2013) 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. 95/001,216 10/26/2009 7562656 8980-78 9982 23552 7590 12/13/2013 MERCHANT & GOULD PC P.O. BOX 2903 MINNEAPOLIS, MN 55402-0903 EXAMINER LEWIS, AARON J ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 12/13/2013 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 PATENT TRIAL AND APPEAL BOARD ____________ MONAGHAN MEDICAL CORP. Requester and Appellant v. PARI GmbH Patent Owner and Respondent ____________ Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 Technology Center 3900 ____________ Before JOHN C. KERINS, DANIEL S. SONG, and RAE LYNN P. GUEST, Administrative Patent Judges. GUEST, Administrative Patent Judge. DECISION ON APPEAL Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 2 Requester Monaghan Medical Corp. (“Requester”) appeals under 35 U.S.C. §§ 134(c) and 315(b) the Examiner’s decision not to reject claims 5, 20-23, 51, and 52. 1 We have jurisdiction under 35 U.S.C. §§ 134(b) and 315(a). We AFFIRM. STATEMENT OF THE CASE United States Patent 7,562,656 B2 (hereinafter the “’656 patent”), which is the subject of the current inter partes reexamination, issued to Thomas Gallem, et al. on July 21, 2009. Patent Owner PARI GmbH (hereinafter “Patent Owner”) filed a Respondent Brief in this appeal. See Patent Owners Respondent Brief 2 (filed December 5, 2012) (hereinafter “PO Res. Br.”). The ’656 patent relates to an apparatus for delivering aerosol medicament to a subject via a mouthpiece. Col. 1, ll. 31-35. Figures 1 and 2 of the ’656 patent are reproduced below. 1 See Requester’s Appeal Brief 2 and 7 (filed November 5, 2012) (hereinafter “Req. App. Br.”); Examiner’s Answer (mailed December 19, 2012) incorporating by reference the Examiner’s Right of Appeal Notice (mailed August 6, 2012) (hereinafter “RAN.”). Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 3 Figure 1 of the ’656 patent is a plan assembled view of an aerosol medicament delivery apparatus of the present invention. Col. 1, ll. 63-64 and col. 2, ll. 13-15. Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 4 Figure 2 of the ’656 patent depicts a perspective exploded view of the aerosol medicament delivery apparatus of Figure 1. Col. 1, l. 65 and col. 2, ll. 13-15. Common limitations of independent claims 5, 20, 51 and 52 include (labeling with respect to Figures 1 and 2 above added for clarity): An apparatus for aerosol medication delivery (10), comprising: a holding chamber (200) having a first and second ends, the first end being adapted to accept a source of aerosol medicament; and a mouthpiece member (100) provided at the second end of the holding chamber, for delivering aerosol medicament to a subject, the mouthpiece member comprising: a housing (101) defining a passage (102) through which aerosol medicament can be supplied to a subject and comprising a sidewall in which an opening (103) is formed that opens to the outside of the housing; and Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 5 a one-piece valve member (150) comprising a first valve element in fluid communication with the mouthpiece (100) and the holding chamber (200), the first valve element within the passage to permit delivery of aerosol to a subject during inhalation and blocks the passage during exhalation and a second valve element in fluid communication with the mouthpiece and the opening (103) in the side wall, the second valve element to prevent air from reaching the subject through the opening (103) in the sidewall of the housing (101) during inhalation and permits the flow of air to the outside of the housing (101) from the passage during exhalation; wherein the first valve element (such as a duckbill valve) extends axially away from the housing (101) when the apparatus is in a rest position. Req. App. Br. 25-29, Claims App’x. At issue in this appeal are further recited limitations in each of claims 5, 20, 51 and 52 which are discussed in further detail below. Requester contests the Examiner’s decision not to reject the claims as follows: I. claims 5, 20-23, 51 and 52 are unpatentable under 35 U.S.C. § 103(a) over Smith 2 in view of Sabo 3 (RAN 22, 24 and 25); II. claims 20-21 are unpatentable under 35 U.S.C. § 103(a) over Smith in view of Mortensen 4 (RAN 23); III. claims 20-21 are unpatentable under 35 U.S.C. § 103(a) over Puderbaugh 5 in view of Sabo and Smith (RAN 23); and 2 US 5,385,140, issued January 31, 1995 to Colin M. Smith. 3 US 5,501,214, issued March 26, 1996 to Kristine K. Sabo. 4 US 5,881,718, issued March 16, 1999 to Preben Korntved Mortensen et al. 5 US 6,026,807, issued February 22, 2000 to George Puderbaugh, et al. Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 6 IV. claims 51 and 52 are unpatentable under 35 U.S.C. § 103(a) over Puderbaugh in view of Sabo (RAN 24 and 25). Neither Requester nor Patent Owner presents any additional evidence for consideration by the Examiner and the Board. See Req. App. Br. 30, Evidence App’x; PO Res. Br. 9, Evidence App’x. CLAIM 5 The Requester proposes that claim 5 is unpatentable over the combined teachings of Smith and Sabo. RAN 22; Req. App. Br. 8-9. Claim 5 recites, inter alia: wherein the housing defining the passage comprises a delivery member and an adaptor member, the adaptor member is provided at the second end of the holding chamber, and the delivery member is releasably connected to the adaptor member; and wherein the opening in the sidewall is defined by a notch defined in an edge of the adaptor member and a notch defined in an edge of the delivery member. See Req. App. Br. 25-26, Claims App’x. Figure 4 and Figure 8 of the ’656 patent are reproduced below. Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 7 Figure 4 depicts a bottom perspective view of the delivery member 110 of a housing 101 having a notch 147. Col. 2, ll. 1 and 64-col. 3, l. 2; see also Figures 1 and 2 supra. Figure 8 depicts a top perspective view of the adaptor member 170 of a housing 101 having a notch 186. Col. 2, l. 7 and col. 6, ll. 10-13 and 27-29. Smith and Sabo The Examiner determined that “[a] careful review of Smith reveals no notch in an edge of the adaptor (e.g.17,12) nor in an edge of delivery member (e.g. 22,23).” Action Closing Prosecution (“ACP”) 34; RAN 25-26. Figure 1 of Smith is reproduced below. Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 8 Figure 1 of Smith depicts a schematic cross-sectional elevational view of a diaphragm valve mechanism showing the diaphragm valve 11 with central portion 32 open, upon the user breathing inwardly, and with peripheral outer edge portion 31 open, upon the user exhaling. Smith, col. 2, ll. 15-17 and col. 3, ll. 56-67. Smith states that, upon the user exhaling, central portion 32 of diaphragm valve 11 will close and be retained in a closed position while peripheral outer edge portion 31 of diaphragm valve 11 will open to allow exhaled breath to escape via passage 27 and exit ports 37 which are shown in Figure 5(a). Col. 3, ll. 63-67; Fig. 5(a). Smith also states that cylindrical holding shell 17 defines an aerosol holding chamber 15 into which an airborne medication is dispensed. Col. 2, ll. 44-50. Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 9 Requester contends that Smith teaches an opening 37 in the sidewall of the housing 23 (delivery member) and that it would have been obvious to one of ordinary skill in the art to have formed a notch in both the housing 23 (delivery member) and in the cylindrical shell 17 (adaptor member) because it would have been no more than the rearrangement of parts, and “an obvious matter of design choice because the specification of the ’656 patent does not disclose that the specific location off (sic, of) the opening provides an advantage, is used for a particular purpose, or solves a stated problem.” Req. App. Br. 9 (citing In re Japiskse, 181 F.2d 1019, 1032 (CCPA 1950)). Requester’s argument is not persuasive. Smith solves the problem of expelling exhaled breath in a different manner than required by the claims. Namely, Smith provides a gap (passage 27) between the structures that Requester identifies as the delivery member and the adaptor member. Thus, providing an opening in the adaptor member (cylindrical shell 17) would not be a reasonable modification to provide a pathway for the exhaled air. To the contrary, repositioning the opening 37 to include defining a notch at the edge of cylindrical shell 17, without additionally reconfiguring the valve placement of Smith, would allow the aerosol medication in chamber 15 to escape cylindrical shell 17. Unlike the situation in In re Japiskse, it would be more than a mere design choice or rearrangement of parts to provide a notch in both the edges of cylindrical shell 17 (adaptor member) and housing 23 (delivery member), as it would also require modification of the operation of the device by modifying the pathway for expelled air and reconfiguration of the valve placement. See 181 F.2d at 1032 (“[T]here would be no invention in shifting the starting switch disclosed by Cannon to a different Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 10 position since the operation of the device would not thereby be modified.”) (emphasis added). Requester puts forth no argument or evidence to suggest that the teachings of Sabo overcome the deficiencies of Smith. See Req. App. Br. 9. Accordingly, we agree with the Examiner’s determination not to adopt the Requester’s proposed rejection of claim 5 based on the teachings of Smith and Sabo. We further agree with the Examiner’s determination not to adopt the Requester’s proposed rejection of claims 22 and 23, which depend from Claim 5, based on the teachings of Smith and Sabo for the same reasons. CLAIM 20 The Requester proposes that claim 20 is unpatentable over the combined teachings of Smith and Sabo, Smith and Mortensen, and/or Puderbaugh, Sabo, and Smith. Req. App. Br. 10-12 and 15-19; see also RAN 22 and 23. Claim 20 recites, inter alia: wherein the housing defining the passage comprises a delivery member and an adaptor member, the adaptor member is provided at the second end of the holding chamber, and the delivery member is releasably connected to the adaptor member; wherein the adaptor member and the delivery member define first and second opposed surfaces and the valve member is held between the first and second opposed surfaces; and wherein one of the delivery member and the adaptor member comprises a plurality of pins that extend from one of the first and second opposed surfaces and the other of the Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 11 delivery member and the adaptor member comprises openings for accepting the pins. See Req. App. Br. 26-27, Claims App’x. Figure 4 and Figure 8 of the ’656 patent, reproduced above, illustrate four positioning pins 141 provided on the adaptor side of the delivery member 110 which drop into four positioning openings 181 on a rim 180 of adaptor member 170 when the two members are joined. See ’656 patent, col. 2, ll. 61-63 and col. 6, ll. 41-46. Smith In each of the rejections of claim 20, the Examiner determined that “Smith (figs. 1, 4a, 4b, 5a, 5b) illustrates a plurality of pins (21) on adapter portion (12) but there are no openings on the delivery portion (22,23) for accepting the pins.” ACP 34, 42 and 44; RAN 26. Requester contends that “one of ordinary skill in the art would recognize that the pins (21) of the adaptor member (12) fit within the gaps formed between opposing and adjacent positioning protrusions (20) of the delivery member (23).” Id. According to Requester, “[u]nder the broadest reasonable interpretation standard, these gaps between opposing and adjacent protrusions (20) define openings in the adaptor member that accept the pins (21).” Id. Figure 1 of Smith is reproduced above and illustrates how projections 20, which are molded integrally with housing 23, prevent diaphragm 11 from lifting off of positioning pins 21 and grid 33. Smith, col. 3, ll. 11-14 and 30-32. Figure 1 shows positioning pins 21 disposed interiorly of the extent of projections 20. Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 12 The issue to be determined is: whether the phrase “openings for accepting pins” is reasonably interpreted to encompass the distances between oppositely disposed projections 20 in housing 23? During reexamination, “claims . . . are to be given their broadest reasonable interpretation consistent with the specification, and . . . claim language should be read in light of the specification as it would be interpreted by one of ordinary skill in the art.” In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (quoting In re Bond, 910 F.2d 831, 833 (Fed. Cir. 1990)). “While the Board must give the terms their broadest reasonable construction, the construction cannot be divorced from the specification and the record evidence.” In re NTP, Inc., 654 F3d 1279, 1288 (Fed. Cir. 2011) (citing In re Suitco Surface, 603 F.3d 1255, 1259 (Fed. Cir. 2010). “Though understanding the claim language may be aided by the explanations contained in the written description, it is important not to import into a claim limitations that are not a part of the claim.” See Superguide Corp. v. DirecTV Enter., Inc., 358 F.3d 870, 875 (Fed. Cir. 2004). We agree with Patent Owner that the space defined by the walls of housing 23 and projections 20 of Smith defines only a single passageway, and thus a single “opening” that “accepts” pins 21. Accordingly, a single opening is insufficient to meet the requirement of claim 20 which recites “openings,” or more than one opening, to accept the plurality of pins. We cannot agree with the Respondent’s assertion that each of the distances between opposing projections 20 constitutes a separate “opening.” We find this reasoning inconsistent with the use of “opening” in the ’656 patent. See, Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 13 e.g., col. 2, ll. 64-67, col. 4, ll. 64-66, and Figure 4 (describing “an opening 145” and “an interior opening 135” of adaptor member 110 defined by walls 142 and 128, respectively). A person of ordinary skill in the art would understand Smith as teaching a single spoke-shaped opening or pathway defined by the walls and projections 20 of housing 23. Requester puts forth no argument or evidence to suggest that the teachings of Sabo, Mortensen or Puderbaugh overcome the deficiencies of Smith. See Req. App. Br. 10-12, 15-17, and 17-19. Accordingly, we agree with the Examiner’s determination not to adopt the Requester’s proposed rejections of claim 20 based on the teachings of Smith and Sabo, Smith and Mortensen, or Puderbaugh, Sabo and Smith. We further agree with the Examiner’s determination not to adopt the Requester’s proposed rejections of claim 21, which depends from Claim 20, based on the teachings of Smith and Sabo, Smith and Mortensen, or Puderbaugh, Sabo and Smith for the same reasons. CLAIMS 51 AND 52 The Requester proposes that claims 51 and 52 are unpatentable over the combined teachings of Smith and Sabo and/or Puderbaugh and Sabo. RAN 24 and 25; Req. App. Br. 12-15. Claim 51 recites, inter alia, that the first valve element is a duckbill valve and: wherein the second valve element extends in a substantially axial direction when the apparatus is not in use. See Req. App. Br. 27-28, Claims App’x. Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 14 Claim 52 recites, inter alia, that the first valve element is a duckbill valve and: wherein the second valve element comprises a hinged flap extending axially in a direction generally parallel to a length of the holding chamber when the apparatus is in the rest position. See Req. App. Br. 28-29, Claims App’x. Thus, both of claims 51 and 52 require a second valve element extending in an axial direction. Figure 5B of the ’656 patent is reproduced below. Figure 5B depicts a top view of the valve system 150 used in the apparatus including a second valve element 153, namely two hinged flaps sized so as to be able to cover a corresponding notch 147 when assembled. See ’656 patent, col. 2, ll. 2-3, col. 3, ll. 11-18, col. 4, ll. 20-23. The ’656 Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 15 patent describes that the hinged flaps cover notch 147 during inhalation and move away from notch 147 during exhalation. Col. 4, ll. 26-30 and 34-41. Sabo In each of the rejections of claims 51 and 52, the Examiner determined that “[w]hen the apparatus of the prior art is not in use, the second valve elements of the prior art (#85 of Puderbaugh), (#31 of Smith) . . . , and (#124 of Sabo) extend in a direction that is transverse to the longitudinal axis of the valve or spacer housing to which each is mounted.” ACP 51; RAN 26 and 27. Figure 7 of Sabo is reproduced below. Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 16 Figure 7 of Sabo depicts an elevational cross-section view of an NRV device 112 including a duck-bill valve element comprising a duck-bill valve 116, a sealing portion 124, a U-shaped region 126 “for rendering the valve element less resistant to the pressure generated by the patient’s expiratory efforts,” and a peripheral portion 122 holding the valve in place. Col. 5, ll. 54-col. 6, ll. 57. Sabo teaches that “sealing portion 124 is adapted to releasably contact internal valve housing seat [128].” Col. 5, l. 66-col. 6, l. 1; see also col. 6, ll. 50-53. “When the patient exhales, the sealing portion 124 separates from valve seat 128 under the influence of the expiratory gas pressure and the expiratory gas is permitted to exit through discharge port means 130.” Col. 6, ll. 55-58. Requester argues that Sabo’s exhalation valve comprising a hinged flap adjacent an opening 130 in a sidewall has a U-shaped region 126 that extends in a substantially axial direction when the apparatus is not in use. Req. App. Br. 12-15 and 20-23. According to Requester, it would have been obvious for one of ordinary skill in the art to modify the exhalation valves of Smith and Puderbaugh in view of Sabo to include a region extending in a substantially axial direction “to reduce resistance to expiratory pressure exerted by a patient.” Id. We disagree with Requester’s characterization of the structure of the valve in Sabo. The second valve element (exhalation valve) of Sabo constitutes the removable contact between the sealing portion 124 and the internal housing valve seat 128. It is the entire central section of the valve of Sabo, including the sealing portion 124 and the duckbill portion 116, that Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 17 functions as the “second valve” recited in the claims, and it is the central section extending substantially in the direction transverse to the axial direction of the device that defines the structure of the second valve. We find it of no moment that the U-shaped portion 126, which is described as part of sealing portion 124, generally extends in an axial direction because it does not constitute the second valve recited in the claims. Rather, the entire central area of the valve 116 including the duckbill feature 134 and the sealing portion 124 flexes away from internal housing valve seat 128 thus removing the contacting seal between sealing portion 124 and the internal housing valve seat 128. The U-shaped portion merely acts as a spring “rendering the valve element less resistant to the pressure generated by the patient’s expiratory efforts.” Thus, we agree with the Examiner that Sabo describes a valve that substantially extends in a direction transverse to the axial direction and does not meet the directional requirements of claims 51 and 52. Requester puts forth no argument or evidence to suggest that the teachings of Smith or Puderbaugh overcome the deficiencies of Sabo. See Req. App. Br. 12-15 and 20-23. Accordingly, we agree with the Examiner’s determination not to adopt the Requester’s proposed rejections of claims 51 and 52 based on the teachings of Smith and Sabo or Puderbaugh and Sabo. DECISION In sum, we affirm the Examiner’s decision not to reject: Appeal 2013-006608 Reexamination Control 95/001,216 Patent 7,562,656 B2 18 I. claims 5, 20-23, 51 and 52 under 35 U.S.C. § 103(a) over Smith in view of Sabo; II. claims 20-21 under 35 U.S.C. § 103(a) over Smith in view of Mortensen; III. claims 20-21 under 35 U.S.C. § 103(a) over Puderbaugh in view of Sabo and Smith; and IV. claims 51 and 52 under 35 U.S.C. § 103(a) over Puderbaugh in view of Sabo. AFFIRMED ack PATENT OWNER: MERCHANT & GOULD PC P. O. BOX 2903 MINNEAPOLIS, MN 55402-0903 THIRD-PARTY REQUESTER: RICKARD K. DEMILLE BRINKS HOFFER GILSON & LIONE P.O. BOX 10395 CHICAGO, IL 60610 Copy with citationCopy as parenthetical citation