Ex Parte Sivigny et alDownload PDFPatent Trial and Appeal BoardDec 27, 201612599565 (P.T.A.B. Dec. 27, 2016) 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. 12/599,565 07/29/2010 Michael B. Sivigny 63206US006 1750 32692 7590 12/29/2016 3M INNOVATIVE PROPERTIES COMPANY PO BOX 33427 ST. PAUL, MN 55133-3427 EXAMINER DIXON, ANNETTE FREDRICKA ART UNIT PAPER NUMBER 3778 NOTIFICATION DATE DELIVERY MODE 12/29/2016 ELECTRONIC 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. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): LegalUSDocketing@mmm.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MICHAEL B. SIVIGNY and PETER D. HODSON Appeal 2015-002428 Application 12/599,565 Technology Center 3700 Before LINDA E. HORNER, ERIC C. JESCHKE, and GORDON D. KINDER, Administrative Patent Judges. HORNER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Michael B. Sivigny and Peter D. Hodson (Appellants)1 seek our review under 35 U.S.C. § 134 of the Examiner’s decision, as set forth in the Non-Final Action, dated March 7, 2014 (“Non-Final Act.”), rejecting claims 26, 33, and 34, which are all of the pending claims. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify 3M Innovative Properties Company as the real party in interest. Br. 2. Appeal 2015-002428 Application 12/599,565 CLAIMED SUBJECT MATTER Appellants’ claimed subject matter relates to “manufacture and provision of valve components, such as valve stems and valve bodies, for use in pressurized metered dose dispensing valves for dispensing pharmaceutical aerosol formulations.” Spec. 1,11. 5-7. Claim 26 is representative of the subject matter on appeal and is reproduced below. 26. A valve component of a medicinal metered dose dispensing valve for use in a medicinal pressurized metered dose dispenser containing a medicinal formulation comprising ethanol and HFA 134a, the valve component comprising 316-grade stainless steel, 316L-grade stainless steel, 304-grade stainless steel, 410-grade stainless steel, or 420-grade stainless steel. REJECTIONS The Non-Final Action included the following grounds of rejection: 1. Claims 26, 33, and 34 under 35 U.S.C. § 103(a) as unpatentable over Garrill (US 6,179,118 Bl, issued January 30, 2001) and Zhang (US 5,075,010, issued December 24, 1991). 2. Claims 26, 33, and 34 under 35 U.S.C. § 103(a) as unpatentable over Garrill and Davis, J.R., “Atmospheric and Aqueous Corrosion,” Stainless Steels: ASM Specialty Handbook, ASM International, 1994, page 133 (“Davis”). 2 Appeal 2015-002428 Application 12/599,565 ANALYSIS Appellants argue the claims subject to each ground of rejection as a group. Br. 3. We select claim 26 as representative of the group for each ground of rejection. Claims 33 and 34 stand or fall with claim 26. 37 C.F.R. §41.37(c)(l)(iv). In each ground of rejection, the Examiner found that Garrill discloses a valve component substantially as claimed in claim 26, including that the valve component is made of stainless steel, except that “Garrill does not expressly disclose the specific grade of stainless steel.” Non-Final Act. 3, 4. With regard to the first ground of rejection, the Examiner found that Zhang discloses the use of 304 and 316-grade stainless steel in construction of a valve “for the purpose of providing [a] valve constructed of a material suitable for obtaining and retaining fluid wherein the selection of the material composition is based upon the impurities of the fluid.” Id. at 3. The Examiner determined it would have been obvious to modify Garrill to use 304 or 316-grade stainless steel “to provide a valve component which is able to obtain[] and retain[] fluid based upon the impurities of the fluid.” Id. at 3—4. With regard to the second ground of rejection, the Examiner found that “Davis teaches the use of 304 and 316 stainless steel in order to provide corrosive resistance.” Id. at 4 (citing Davis 133 (col. 1, para. 3)). The Examiner determined it would have been obvious to modify Garrill to use 304 or 316-grade stainless steel “in order to provide corrosion resistance.” Id. at 4-5. 3 Appeal 2015-002428 Application 12/599,565 With regard to the first ground of rejection, Appellants contend that “nothing in Garrill or Zhang identifies corrosion resistance as a problem to be solved in the field of [metered dose inhalers (MDIs)].” Br. 6.2 The Examiner responds that: corrosion of stainless steel may occur in various environments, including but not limited to environments where “oxygen and water” may or may not be present. Specifically, various known types of stainless steel corrosion include but are not limited to pitting, crevice (based on low oxygen environments), galvanic (rust), leaching, erosion, intergranular (based on high temperature), and stress (based on chloride compositions), wherein the solution/material in contact with the stainless steel permits for the corrosive environment. Ans. 7. The Examiner further notes that Davis discloses several factors that affect corrosivity including “the concentration of [the] chemical species, pH, aeration, flow rate (velocity), impurities (such as, chlorides) and temperature.” Id. (quoting Davis 133 (col. 1, para. 3)). In other words, we understand the Examiner’s position to be that corrosion is a factor to be considered whenever stainless steel is used in an environment that permits corrosion. Garrill discloses the use of stainless steel in such an environment. We agree with the Examiner that Garrill discloses a stainless steel valve component of a medicinal metered dose dispensing valve for use in a dispenser containing a medicinal formulation comprising ethanol and HFA 2 Notably, Appellants are not contending that corrosion is not a problem in MDIs or that they were the first to discover the problem of corrosion in MDIs. 4 Appeal 2015-002428 Application 12/599,565 134a. Non-Final Act. 3 (citing Garrill, col. 4,11. 31^12, 65-66, col. 5,1. 65- col. 6,1. 43). Garrill discloses that the pressurized container comprising the valve component is filled with a drug formulation, which includes a mixture of a drug (Garrill, col. 5,11. 14-53), a propellant (e.g., HFA 134a) {id. at col. 5,1. 55-col. 6,1. 2), and an excipient (e.g., ethanol) {id. at col. 6,11. 4^12). “The pressurized container 34 preferably includes a liquid stored within the pressurized container 34 at a predetermined pressure. The liquid preferably includes a drug dispersed or dissolved therein such as salmeterol or fluticasone propionate.” Id. at col. 11,11. 33-37. Garrill further discloses that “where appropriate, the medicaments may be used in the form of. . . solvate (e.g. hydrates) to optimise the activity and/or stability of the medicament and/or to minimize the solubility of the medicament in the propellant.” Id. at col. 5,11. 44 49. Thus, the medicinal formulation with which the valve component of Garrill comes into contact may include water in the form of a hydrate of the drug that forms the formulation, along with the propellant and the excipient. In light of these findings, we agree with the Examiner’s determination that one having ordinary skill in the art would have taken into account the environment in which the valve component operates, including the interaction of the stainless steel with the medicinal formulation with which it comes in contact and any corrosive effects of the formulation on the valve component material, when selecting the grade of stainless steel to use for the valve component. Appellants further argue that “Zhang is concerned with aqueous corrosion” while “the medicinal formulation recited in claim 26 is a non- 5 Appeal 2015-002428 Application 12/599,565 aqueous composition” and thus “[t]he Examiner has provided no technical authority to support extrapolating the teaching of Zhang, which deals with corrosion in a water-abundant and oxygen-abundant environment, to a water-starved and oxygen-starved environment.” Br. 6. Appellants present the same arguments in rebuttal to the second ground of rejection based on Garrill and Davis. Br. 8-9 (Appellants arguing that Davis “is concerned with atmospheric and aqueous corrosion, which . . . relate[s] to water- abundant and oxygen-abundant environments” and thus, the rejection “is based on a ‘problem’ that is not evident from Garrill that is ‘solved’ by extrapolating the inapposite teachings of Davis”). We agree with the Examiner that the claim language does not recite the medicinal formulation is a “non-aqueous composition,” and Appellants’ Specification does not support such a narrow reading of claim 26. Ans. 6 (Examiner noting that “this limitation of ‘water-starved and oxygen-starved’ has not been recited in the claim listing” and “there is no disclosure that [the] ‘medicament formulation recited in claim 26 is a non-aqueous composition’”). Although the Specification discusses dispensing “pharmaceutical aerosol formulations” (see, e.g., Spec. 1,11. 7, 11, 17), the claim language is not as limited, reciting only a “medicinal formulation comprising ethanol and HFA 134a.” Br. 11 (Claims App.) (emphasis added). As noted by the Examiner, the use of the open-ended term “comprising” means that the claimed “medicinal formulation” can include components in addition to the propellant and excipient, such as an aqueous drug. Ans. 6. We also note that “aerosol” does not connote necessarily a 6 Appeal 2015-002428 Application 12/599,565 non-aqueous composition, as an “aerosol” encompasses either solid particles or liquid droplets dispersed in air or gas.3 Further, Garrill discloses an MDI containing an aqueous composition, and the Examiner provided reasoning to support application of the teachings of Zhang and Davis to the environment of Garrill. Non-Final Act. 3—5. Appellants further argue “the Examiner has failed to establish that Zhang provides teaching that leads a person of ordinary skill in the art to modify the valve component described in Garrill to arrive at the valve component recited in claim 26 with predictable results.” Br. 7 (Appellants arguing that “Zhang provides no discussion of corrosion beyond the specific oxygen-abundant aqueous environment of groundwater filtering”). Appellants present similar arguments for the second ground of rejection based on Garrill and Davis. Br. 9 (Appellants arguing that “the information provided in Davis . . . provides no predictive information that relates to corrosion resistance in a water-starved and oxygen-starved environment”). These arguments turn on the asserted distinction between a water- abundant and oxygen-abundant environment of Zhang and Davis, and a non- aqueous environment of the claimed invention. For the reasons set forth above, we find this distinction is not commensurate in scope with the claim language. Further, we note that Garrill discloses an aqueous environment, in 3 “Aerosol” is defined as “a suspension of fine solid or liquid particles in gas” and “a substance (as an insecticide or medicine) dispensed from a pressurized container as an aerosol.” https://www.merriam- webster.com/dictionary/aerosol. 7 Appeal 2015-002428 Application 12/599,565 which the teachings of Zhang and Davis of how to select a grade of stainless steel to resist corrosion in such an environment, would have direct applicability. Further, we agree with the Examiner’s finding that “there is predictability as more corrosive formulations require more corrosion resistant stainless steels in order to prevent failure and encourage proper operation, while less corrosive formulation may utilize less corrosion resistant stainless steels.” Ans. 8. As explained by the Examiner, Davis teaches that the “selection of the appropriate grade of stainless steel is then a balancing of the desire to minimize cost and the risk of corrosion damage by excursions of environmental conditions during operation or downtime.” Ans. 9 (citing Davis 133 (col. 3,11. 3-8)). We find the Examiner’s determination that one having ordinary skill in the art would have been led by the teachings of Zhang and Davis to select the claimed stainless steel grade in the device of Garrill based on the desired corrosion resistance necessitated for the intended use of the valve is based on rational underpinnings. Id. Appellants have not demonstrated adequately an unpredictability in this art that would render unobvious the use of the claimed grades of stainless steel in the valve component of Garrill. For these reasons, we sustain the rejections of claim 26, and claims 33 and 34, which fall with claim 26, under 35 U.S.C. § 103(a) as unpatentable over Garrill and one of Zhang and Davis. 8 Appeal 2015-002428 Application 12/599,565 DECISION The decision of the Examiner to reject claims 26, 33, and 34 is AFFIRMED. 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)(l)(iv). AFFIRMED 9 Copy with citationCopy as parenthetical citation