Ex Parte Franciskovich et alDownload PDFPatent Trial and Appeal BoardOct 24, 201713480565 (P.T.A.B. Oct. 24, 2017) 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. 13/480,565 05/25/2012 Phillip P. Franciskovich STRSP0118USB 5380 23908 7590 10/26/2017 RENNER OTTO BOISSELLE & SKLAR, LLP 1621 EUCLID AVENUE NINETEENTH FLOOR CLEVELAND, OH 44115 EXAMINER CHOI, FRANK I ART UNIT PAPER NUMBER 1616 NOTIFICATION DATE DELIVERY MODE 10/26/2017 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): ipdocket @ rennerotto. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PHILLIP P. FRANCISKOVICH, DONALD G. ROSENHAMER, KATHLEEN A. FIX, and DANA HALL Appeal 2016-008043 Application 13/480,5651 Technology Center 1600 Before ULRIKE W. JENKS, ELIZABETH A. LaVIER, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving “a composition suitable for sterilizing articles such as medical, dental, pharmaceutical, veterinary or mortuary instruments, devices, and the like.” Specification 1. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a) and provisionally on the ground of non-statutory obviousness-type double patenting. We affirm. 1 According to Appellants, the real party in interest is American Sterilizer Company. App. Br. 3. Appeal 2016-008043 Application 13/480,565 STATEMENT OF THE CASE Claims 1—35 are on appeal. Claim 1 is illustrative and reads as follows: 1. A sterilizing apparatus comprising a sterilization chamber and a sterilant introduction system, wherein the sterilant introduction system separately supplies components (A) and (B) to form an aqueous composition consisting essentially of the components (A) and (B): (A) an anti-microbial agent consisting essentially of peracetic acid; and (B) a reagent mixture consisting essentially of a buffer, an anticorrosive agent and a chelator; wherein the composition does not contain molybdate, and wherein the components (A) and (B) in the sterilant introduction system are in an initial weight ratio of (A) to (B) from 0.45 to 1.3, component (A) comprises from 15% to 45% by weight of peracetic acid, and component (B) comprises from 35% to 98% by weight of the buffer, from 0.5% to 35% by weight of the anticorrosive agent, and from 0.3% to 60% by weight of the chelator. App. Br. 18. The claims stand rejected as follows: Claims 1—35 were rejected under 35 U.S.C. § 103(a) as unpatentable over the combination of Huth2 and Kralvoic.3 Claims 1—35 were provisionally rejected on the ground of non- statutory obviousness-type double patenting over claims 20—22, and 24-46 of copending Application No. 13/440,405.4 2 Huth et al., US Patent No. 6,448,062 Bl, issued Sept. 10, 2002 (“Huth”). 3 Kralovic et al., US Patent No. 4,731,222, issued Mar. 15, 1988 (“Kralovic”). 4 Application No. 13/440,405 is involved in copending Appeal No. 2016- 008041. The appeal addressed almost identical issues and involved the same 2 Appeal 2016-008043 Application 13/480,565 OBVIOUSNESS Appellants argue claims 1—35 together as a group. We designate claim 1 as representative for the group. The Examiner found that Huth disclosed a composition including all of the elements of claim 1 and that the only differences between claim 1 and Huth relate to using an apparatus where the article is placed in a sterilization chamber and to certain of the dependent claims that Appellants do not separately argue. Final Act. 2—10.5 We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art (Ans. 3—13; Final Act. 2—16) and agree that the claims are obvious over the combination of Huth and Kralovic. We address Appellants’ arguments below. Appellants argue that Huth teaches that the composition relied upon by the Examiner was intended to be combined with a cleaning composition that includes an enzyme. Appellants explain: While Huth et al. discloses a composition at col. 29, lines 10-20 that does not include an enzyme, this composition is disclosed as the disinfecting portion of the disclosed combined cleaning/ disinfecting composition, and would not be capable of the Huth-claimed simultaneous cleaning and disinfection. Real Party in Interest. Indeed, the argument portion of the briefs submitted in both cases is substantially identical. Notwithstanding the fact that significant portions of the briefs submitted in the two appeals were substantially identical, submitted on the same day, and signed by the same person, Appellants failed to identify the related appeal as required by 37 C.F.R. § 41.37(c)(ii). Appellants also failed to identify this case as related to Appeal No. 2016-000813, which involves similarly overlapping subject matter and briefing. 5 Office Action mailed July 22, 2015 (“Final Act.”). 3 Appeal 2016-008043 Application 13/480,565 App. Br. 10. Appellants then argue that the present claims are distinguishable over Huth because the claims are limited by the transitional phrase “consisting essentially of’ and the addition of an enzyme would materially change the basic and novel characteristics of composition used in connection with the claimed apparatus. Id. at 11—15. We are not persuaded. Claim 1 identifies the claim as being directed to “a sterilizing apparatus” comprising “sterilant introduction system” for an “aqueous composition.” The Specification defines the term “sterilizing” as follows: The term “sterilization” refers to rendering a substance incapable of reproduction, metabolism and/or growth. The term “sterilization” includes microbial deactivation. While sterilization is often taken to refer to a total absence of living organisms, the term may be used herein to refer to a substance free from living organisms to a degree agreed to be acceptable. Unless otherwise indicated, the term “sterilization” may be used herein to also refer to processes less rigorous than sterilization, for example, disinfection, sanitization, decontamination, cleaning, and the like. Variations of the term “sterilization,” such as sterilant, sterilizing, etc., may also be used herein to refer to and encompass related variants associated with sterilization processes as well as processes less rigorous than sterilization (e.g., disinfectant, disinfecting, etc.). Spec. 3. Huth discloses the following composition, described as an “[ajqueous solution of disinfecting agent.” Kuaeiiofi&l CoKiponeM Haw Materia* Concerttratio n ^?NV ,v Dislatecuag agest hydrogen peroxide 6,0-b,0 Disinfecting agent peracetic acid aos-o.20 Chel&dag age sit Na.EDTA 0.05-0.35 11,0, Stabi lizer Dequest 2010 0.10-1,0 Bitfl'et/H-,O, st a bi. lizer boric add (1006-0,60 Anticorrosive 3,2.3 - b enzo ttia zol e 0.10-1.0 Diluent water q.s. to volume- 4 Appeal 2016-008043 Application 13/480,565 Huth col. 29,11. 8—20. Huth uses the term “disinfection” to refer to “the removal of hazardous or unwanted materials such as bacteria, mold spores or other pathogenic forms and the like” and distinguishes between “high-level disinfection,” “intermediate-level disinfection,” and “low-level disinfection,” each of which provides different levels of decontamination. Huth col. 1,11. 28—33 and 41—45, and col. 2,11. 29—31 and 39-42. Huth’s disinfecting composition is, by itself, a “sterilizing” composition as that term is defined in the Specification. While it is true that Huth contemplates that its disinfecting composition will ultimately be used together with a cleaning composition, the disinfecting composition is separately disclosed. Id. at col. 29,11. 8—20. In addition, as the Examiner points out, Huth discloses examples in which the antimicrobial efficacy of peracetic acid compositions was tested without an enzyme. Ans. 5 (citing Huth Examples 12 and 13, col. 43,1. 63 — col. 46, 1. 26). Because Huth’s disinfecting composition can be used without an enzyme, Huth’s disclosure of an enzyme that may be used with its disinfecting composition does not distinguish that disinfecting composition from the composition recited in connection with the claimed sterilizing apparatus. Our finding that Huth discloses a disinfecting composition that can be used without an enzyme renders moot Appellants’ argument that the transitional phrase “consisting essentially of’ precludes the presence of an enzyme. Nonetheless, we note that we agree with the Examiner that the basic and novel properties of the claimed composition relate to the activity of the composition as a sterilizer, not to the advantages — including number ingredients, complexity of formulation, and/or cost of the ingredients — that 5 Appeal 2016-008043 Application 13/480,565 one embodiment of the claimed composition enjoys as compared to a single selected prior art composition. See Ans. 5—6. We further note that Appellants have not persuaded us that the presence of an enzyme would materially affect the sterilizing properties of Huth’s disinfecting composition. We acknowledge the declaratory testimony offered by Appellants that the presence of an enzyme reduces the amount of peracetic acid available for sterilization. See Kaiser Deck614. As the Examiner points out, however, Huth includes examples in which peracetic acid compositions including an enzyme retained antimicrobial activity. Ans. 5 (citing Huth Examples 12 and 13, col. 43,1. 63 — col. 46, 1. 26). Thus, even if we were to accept Appellants’ argument that, for purposes of assessing obviousness, Huth’s disinfecting composition can only be considered in connection with an enzyme, we find that the presence of the enzyme does not materially affect the basic and novel characteristics of the disinfecting composition.7 Appellants argue that claim 1 is not obvious over Huth because Huth’s disinfecting composition includes at least a H2O2 stabilizer, Dequest 2010®, the active ingredient of which (hydroxyethylidenediphosphonic acid) is excluded from the claims by the transitional phrase “consisting essentially of.” App. Br. 15—17. We are not persuaded. The Dequest 2010® component of Huth’s disinfecting composition is identified as a hydrogen peroxide stabilizer. Huth col. 29,11. 8—20. While 6 Declaration of Nancy Kaiser under 37 C.F.R. § 1.132, signed March 23, 2015 (“Kaiser Decl.”). 7 Appellants’ arguments regarding the effect of peracetic acid on the properties of the enzyme are not relevant because it is the sterilizing composition that is claimed, not the enzyme. 6 Appeal 2016-008043 Application 13/480,565 Huth does teach a need for a hydrogen peroxide stabilizer and exemplify a composition including Dequest 2010® as such a stabilizer {id.), Huth expressly states: “destabilization can be prevented with sequestrants such as hydroxy-ethylidene diphosphonic acid (Dequest 2010™, Monsanto Co.), or with the use of conventional chelating agents.’ '’ Id. at col. 22,11. 31—35 (emphasis added). In view of this statement, a person of ordinary skill in the art would have recognized Dequest 2010® as interchangeable with conventional chelating agents and it would have been obvious to substitute a “conventional chelating agent” for Dequest 2010® in Huth’s disinfecting composition. See KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.”). As claim 1 expressly includes a “chelator” as part of the claimed composition, the use of a conventional chelating agent does not render the claimed composition nonobvious over Huth. Our finding that Huth’s disinfecting composition may use a “conventional chelating agent,” renders moot Appellants’ argument that the transitional phrase “consisting essentially of’ precludes the presence of a peroxide stabilizer. Nonetheless, we note that Huth uses Dequest 2010® and/or conventional chelating agents to stabilize its composition. Huth col. 22,11. 21—39. We recognize the testimony of Mr. Rosenhamer that because the use of a stabilizer “would affect the stability and activity of the [composition], it must necessarily affect the ‘basic and novel characteristics’ 7 Appeal 2016-008043 Application 13/480,565 of any . . . composition to which it is added.” See Rosenhamer Decl.814. However, we are not persuaded because we do not consider stability to be a basic and novel characteristic of the claimed compound. Accordingly, we affirm the Examiner’s decision to reject claims 20— 22 and 24-46 under 35 U.S.C. § 103(a) as unpatentable over the combination of Huth and Kralvoic. DOUBLE PATENTING Appellants do not address the Examiner’s provisional obviousness- type double patenting rejection. We therefore summarily affirm this rejection. See Manual of Patent Examining Procedure § 1205.02 (“If a ground of rejection stated by the examiner is not addressed in the appellant’s brief, that ground of rejection will be summarily sustained by the Board.”). SUMMARY For these reasons and those set forth in the Examiner’s Answer, and the Final Office Action, we affirm the Examiner’s rejection of claims 1—35 under 35 U.S.C. § 103(a) as unpatentable over the combination of Huth and Kralvoic and the Examiner’s provisional rejection of claims 1—35 on the ground of nonstatutory obviousness-type double patenting over claims 20— 22 and 24-46 of copending Application No. 13/440,405. 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). AFFIRMED 8 Declaration of Donald G. Rosenhamer under 37 C.F.R. § 1.132, signed July 22, 2013 (“Rosenhamer Decl.”). 8 Copy with citationCopy as parenthetical citation