Ex Parte Schuler et al

Patent Trial and Appeal BoardApr 30, 2013

10601127 (P.T.A.B. Apr. 30, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte CARLOS SCHULER, STEVE PABOOJIAN, DERRICK J. TUTTLE, ADRIAN E. SMITH, DENNIS R. RASMUSSEN, ANEESH BAKSHI, ANDREW CLARK, BRIAN R.S. WARD, WILLIAM W. ALSTON, JR., and KEVIN S. NASON ____________________ Appeal 2011-003188 Application 10/601,127 Technology Center 3700 ____________________ Before: WILLIAM V. SAINDON, NEIL T. POWELL, and BEVERLY M. BUNTING, Administrative Patent Judges. SAINDON, Administrative Patent Judge. DECISION ON APPEAL Appeal 2011-003188 Application 10/601,127 2 STATEMENT OF THE CASE Appellants appeal under 35 U.S.C. § 134 from the Examiner’s decision rejecting claims 53-60. We have jurisdiction under 35 U.S.C. § 6(b). The Claimed Subject Matter Claim 53, reproduced below, is illustrative of the claimed subject matter. 53. A method for aerosolizing a pharmaceutical formulation, the method comprising: providing a valve within an airway leading to the lungs to prevent respiratory gases from flowing to the lungs when a user attempts to inhale, and then abruptly permitting respiratory gases to flow to the lungs by opening the valve when a threshold actuating vacuum caused by the attempted inhalation is exceeded, providing a flow regulator within the airway, wherein the flow regulator varies the flow resistance through the airway to control the flow of respiratory gases, wherein the flow resistance through the flow regulator is low when the respiratory gases are permitted to flow and increases when the vacuum generated by the user increases thereafter; and using the flow of respiratory gases to extract a pharmaceutical formulation from a receptacle and to place the pharmaceutical formulation within the flow of respiratory gases to form an aerosol. References The Examiner relies upon the following prior art references: McAughey Clarke Schultz US 5,724,959 US 5,727,546 US 6,116,237 Mar. 10, 1998 Mar. 17, 1998 Sep. 12, 2000 Appeal 2011-003188 Application 10/601,127 3 Rejections I. Claims 53-55, 57, and 59 are rejected under 35 U.S.C. § 102(b) as anticipated by Clarke. Ans. 3. II. Claim 56 is rejected under 35 U.S.C. § 103(a) as unpatentable over Clarke and Schultz. Ans. 6. III. Claims 58 and 60 are rejected under 35 U.S.C. § 103(a) as unpatentable over Clarke. Ans. 6. IV. Claim 60 is rejected under 35 U.S.C. § 103(a) as unpatentable over Clarke and McAughey. Ans. 7. SUMMARY OF DECISION We AFFIRM. OPINION Rejection I – Anticipation by Clarke1 The Examiner found that Clarke discloses a valve 24 and a flow regulator 23. Ans. 3-4. Appellants argue that Clarke does not disclose a separate threshold valve and flow regulator. App. Br. 4-5. First, we note that claim 53 does not specify a structural relationship between the valve and flow regulator, and specifically, it does not preclude them being attached to one another. Claim 53 merely specifies that the method has steps of providing a valve and a flow regulator that perform the claimed functions. The Examiner’s findings that portion 24 of vane 27 satisfies the limitations set forth for the claimed valve and that portion 23 of vane 27 satisfies the 1 Appellants argue the claims of Rejection I as a group; we select claim 1 as representative. See App. Br. 6. Appeal 2011-003188 Application 10/601,127 4 limitations set forth for the claimed flow regulator are well reasoned. As the Examiner explains, portion 24 performs the claimed function of preventing respiratory gasses from flowing into the lungs when a user attempts to inhale by way of the biasing spring. Ans. 3-4, 8-9. Accordingly, this argument is unpersuasive. Appellants next argue that Clarke does not disclose a flow regulator wherein flow resistance is low when gases are permitted to flow and increases when the vacuum increases thereafter. App. Br. 5. Appellants explain that “permitted to flow” should be interpreted to mean “first permitted to flow.” App. Br. 5-6; Reply Br. 4-5. That Appellants require the addition of the word “first” to clarify their desired meaning of the claim suggests that such a word is necessary to distinguish. Indeed, permission is a state, not just an event that occurs at a single point in time. Air is permitted to flow whenever it is allowed to flow. Appellants point to nothing in the Specification that necessitates their narrow interpretation. Accordingly, we are not apprised of error in the Examiner’s rejection, which states that gases are permitted to flow in Clarke (fig. 2b) and flow resistance provided by the flow regulator increases as vacuum increases (fig. 2c). Ans. 4, 9.2 Having reviewed Appellants’ arguments in both Briefs, we are not apprised of error in the Examiner’s rejection of claim 53. Claims 54, 55, 57, and 59 fall therewith. 2 We note that even if the claim were amended to include “first permitted,” the flow regulator 23 of Clarke blocks the least amount of air immediately (fig. 2a), and blocks an increasing amount of air as vacuum increases and the flow regulator rotates into the air stream (2b, 2c). The particular aspect of the claim argued here is directed to increasing resistance through the flow regulator, not resistance through the airway (which is, itself, merely varied). Appeal 2011-003188 Application 10/601,127 5 Rejection II – Obviousness over Clarke and Schultz Appellants argue that Schultz does not make up for alleged deficiencies in Clarke (in the rejection of claim 53). App. Br. 7. Not being apprised of deficiencies of Clarke in that regard, we sustain Rejection II. Rejection III – Obviousness over Clarke Appellants argue that “Clarke et al fails to disclose or teach the duckbill valve” of claim 58. App. Br. 6. As the Examiner points out, Clarke describes a duckbill valve in figure 9(a). Ans. 6, 9-10. Accordingly, Appellants’ argument fails to apprise us of error. Appellants next argue, with respect to claims 58 and 60, that the Examiner’s modification is deficient as not being “well within the grasp of one of ordinary skill” and as not having “evidence to suggest.” App. Br. 7. These bald allegations are not persuasive in view of the Examiner’s articulated reasons and factual underpinnings, which evidence that a duckbill valve is substitutable (being an alternative in the same reference) and that explain that parallel/serial arrangements are obvious design choices. Ans. 6- 7, 9-10. Appellants provide no explanation as to why we should accept that such modifications are not “well within the grasp of one of ordinary skill.” Having reviewed Appellants’ arguments in both Briefs, we are not apprised of error in Rejection III. Rejection IV – Obviousness over Clarke and McAughey The Examiner provides an alternative rejection for claim 60, citing McAughey for the premise that a parallel arrangement is known in the art. Ans. 7-8. Appellants merely state that McAughey does not make up for the deficiencies of Clarke (in the rejection of claim 53). Reply Br. 4. Not being apprised of deficiencies of Clarke in that regard, we sustain Rejection IV. Appeal 2011-003188 Application 10/601,127 6 DECISION We AFFIRM the Examiner’s decision regarding claims 53-60. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Klh