WHITELEY CORPORATION PTY LTDDownload PDFPatent Trials and Appeals BoardApr 1, 20212020004217 (P.T.A.B. Apr. 1, 2021) 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. 15/035,633 05/10/2016 Trevor Glasbey 13124.00004(US from PCT) 4908 67883 7590 04/01/2021 Pryor Cashman LLP Patent Department 7 Times Square NEW YORK, NY 10036-6569 EXAMINER BASQUILL, SEAN M ART UNIT PAPER NUMBER 1613 MAIL DATE DELIVERY MODE 04/01/2021 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 Ex parte TREVOR GLASBEY Appeal 2020-004217 Application 15/035,633 Technology Center 1600 Before ULRIKE W. JENKS, TAWEN CHANG, and DEVON ZASTROW NEWMAN, Administrative Patent Judges. Opinion for the Board filed by NEWMAN Opinion Concurring-in-Part and Dissenting-in-Part filed by CHANG NEWMAN, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 3, 6–8, 11–15, and 18. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Whiteley Corporation Pty Ltd. Appeal Br. 3. Herein, we refer to the Appeal Brief Appeal 2020-004217 Application 15/035,633 2 STATEMENT OF THE CASE Organic peroxy acids, such as peracetic acid (PAA), have numerous advantageous properties for use as disinfectants. In particular peracetic acid displays a broad spectrum of biological activity including bactericidal, fungicidal, biocidal, and particularly sporicidal. Furthermore, peracetic acid is not deactivated by catalase and peroxidase, the enzymes responsible for breaking down hydrogen peroxide, and typically found in the tissues of all animal and plant species, as well as most aerobic bacteria. Spec. 1:6–12. However, the Specification states that peracetic acid is “typically supplied as an equilibrium mixture, also containing the precursor materials hydrogen peroxide and acetic acid,” and that peracetic acid generated by direct reaction of these precursors has a “sharp, pungent odour (due to the excess acetic acid) and [a] highly acidic pH [that] makes the solution corrosive to many surfaces.” Id. at 1:23–27. In addition, the solution is thermodynamically unstable. Id. at 1:29. The Specification states that, to avoid the above problems, “systems have been developed to generate . . . peracetic acid in situ from more stable precursors by reacting suitable peroxide sources with an acetyl transfer agent (activator)” such as tetraacetylethylenediamine (TAED). Id. at 2:1–3, 2:27– 28. According to the Specification, such formulations may be provided in the form of a powdered blend “which, upon dissolution in water, react to form the peroxy acid in situ.” Id. at 2:8–10. Further according to the Specification, a disadvantage of such a formulation is that “peracetic acid is filed March 26, 2020 (“Appeal Br.”), the Examiner’s Answer filed April 22, 2020, (“Ans.”), and the Reply Brief filed May 19, 2020 (“Reply Br.”) Appeal 2020-004217 Application 15/035,633 3 not generated instantaneously” and “[t]he requisite target peracetic acid concentration may not therefore be reached until several minutes after full dissolution of the precursor powder,” which in turn “poses real risk that the end user may begin to use the disinfectant solution before an effective amount of the active agent has been produced, leading to potentially compromised disinfection.” Id. at 4:27–30, 5:4–8. The Specification states that “it would be desirable to provide a means to provide the user with an indication of when sufficient peracetic acid has been generated and therefore when the disinfectant solution is ready for use.” Id. at 5:10–12. CLAIMED SUBJECT MATTER The claims are directed to powder compositions for generating peracetic acid. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A powder composition for generating and indicating an initial achievement of a biocidally effective concentration of peracetic acid upon dissolution in water, the powder composition consisting essentially of: (a) a hydrogen peroxide source; (b) an acetyl source; and (c) a peracetic acid bleachable dye, wherein said composition is configured to generate and indicate an initial achievement of a biocidally effective concentration of peracetic acid upon dissolution in water, said indication being a substantial removal of color generated by said peracetic acid bleachable dye. Appeal Br. 21 (Claims App.). Appeal 2020-004217 Application 15/035,633 4 REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Ramon T. Ignacio, et al. US 6,287,518 B1 September 11,2001 Patricia A. Antonoplos, et al. US 6,551,555 B2 April 22, 2003 Stanley William Huth US 2003/0096720A1 May 22, 2003 Ulrich Pegelow, et al. US 2007/0197416 Al August 23, 2007 REJECTIONS 1. Claims 1, 3, 6–8, 11–15, and 18 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement. Ans. 3. 2. Claims 1, 3, 6–8, 11–15, and 18 are rejected under 35 U.S.C. § 103 as being unpatentable over Huth, Antonoplos, Ignacio, and Pegelow. Id. at 5. OPINION A. Written Description The Examiner finds that “Appellant’s disclosure as originally filed is devoid of any mention whatsoever of a composition ‘consisting essentially of’ a hydrogen peroxide source, an acetyl source, and a peracetic acid bleachable dye.” Ans. 4. The Examiner concludes that the absence of direct support in the Specification for the amendment, which replaced “comprising” in sole independent claim 1 with “[the] powder compositions Appeal 2020-004217 Application 15/035,633 5 ‘consisting essentially of,’” warrants a new matter rejection.2 Id. The Examiner states that because “consisting essentially of” limits the scope of each claim to the specified steps or materials claimed and any that “do not materially affect the basic and novel characteristic(s)” of the claimed invention, that, to support this claim structure, the Specification would need to delineate “precisely which basic and novel characteristics the invention provides which additional included agents must not materially affect.” Id. The Examiner finds that Appellant instead provides “[a] litany of additional components which are explicitly envisioned as suitably combined with the three required elements of the composition claimed.” Id. Because the Specification does not clearly identify the basic and novel characteristics of the invention, the Examiner finds that the skilled artisan would not have had “any guidance though the forest of potential additional composition components known at the time.” Id. The Examiner concludes that the claims are not supported by sufficient written description. Id. at 5. Appellant argues that the Specification clearly articulates the invention the invention of independent claim 1 is directed to a powder composition that, upon dissolution in water, provides dual benefits: (1) The generation of a biocidally effective concentration of peracetic acid (“PAA”), which may serve as, e.g., a hospital disinfectant for surface cleaning; and (2) The indication of an initial achievement, i.e., the temporal onset, of a biocidally effective concentration of PAA. 2 Applicant’s claim amendments were submitted with its “Request for Continuation Examination (RCE) and Amendment in Response to July 5, 2019 Final Office Action” on October 3, 2019. Appeal 2020-004217 Application 15/035,633 6 Appeal Br. 7 (citing claim 1 as originally filed and Specification 10:3–6). Appellant argues that this description clearly describes the basic and novel characteristics of the invention as required by 35 U.S.C. § 112, which Appellant defines as: For the first characteristic relating to PAA generation, the claimed components/materials contributing to this aspect are “(a) a hydrogen peroxide source” and “(b) an acetyl source”; when (a) and (b) are dissolved in water, they produce PAA, a known disinfectant. . . . For the second characteristic relating to the onset or first indication of an efficacious concentration or amount of PAA in water, the claimed component/material contributing to this aspect is “(c) a peracetic acid bleachable dye.” Appeal Br. 8; Reply Br. 10. Appellant argues that additional materials like “one or more of an acidifying agent, a wetting agent, a pH buffering agent, a sequestering agent, a flow modifier, a perfume, other additives, or combinations thereof” do not affect the basic and novel characteristics of the claimed invention. Appeal Br. 10–11. We agree with Appellant that the Examiner has not shown that the Specification fails to adequately describe the claimed composition. A description adequate to satisfy 35 U.S.C. § 112, first paragraph, must “clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” In other words, the test for sufficiency is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (citation omitted, alteration in original). “The descriptive text needed to meet these requirements varies with the nature and scope of the invention at Appeal 2020-004217 Application 15/035,633 7 issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The phrase “consisting essentially of” is a transition phrase that, when used before a list of ingredients in a composition claim, indicates that “the invention necessarily includes the listed ingredients [but] is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention.” HZNP Medicines LLC v. Actavis Laboratories UT, Inc., 940 F.3d 680, 692–693 (Fed. Cir. 2019) (quoting AK Steel Corp. v. Sollac & Ugine, 344 F.3d 1234, 1239 (Fed. Cir. 2003)). Thus, to satisfy the written description requirement, Appellant’s disclosures must reasonably convey to those skilled in the art that the inventor had possession of a powder composition that (1) includes a hydrogen peroxide source, an acetyl source, and a peracetic acid bleachable dye, and (2) does not include any ingredients that would materially affect the basic and novel properties of a composition of these listed ingredients. The Specification describes a composition comprising a hydrogen peroxide source, an acetyl source, and a peracetic acid bleachable dye. Spec. 7:9–13. The composition, when dissolved in solution, generates color via the peracetic acid bleachable dye at the point when the concentration of peracetic acid is biocidally effective (ready for use as a disinfectant). Id. at 7:14–16. The composition is preferably provided in powder form. Id. at 10:11. The Specification further describes optionally added components: “wetting agents, sequestering and chelating agents, and other ingredients, such as bleach stable fragrances, corrosion inhibitors, powder flow modifiers, rheology modifiers etc.” Id. at 11:7–9. Finally, as Appellant Appeal 2020-004217 Application 15/035,633 8 points out, Appeal Br. 9–10, the Specification at 16:14–24 identifies a preferred embodiment that describes precisely the recited components and their function in the composition. We find these disclosures to be sufficient, in light of the scientific and technological knowledge in existence at the time of the invention, to satisfy the written description requirement. Capon, 418 F.3d at 1357. In short, we agree with Appellant that the Specification shows possession of a powder composition consisting essentially of: (a) a hydrogen peroxide source; (b) an acetyl source; and (c) a peracetic acid bleachable dye, wherein said composition is configured to generate and indicate an initial achievement of a biocidally effective concentration of peracetic acid upon dissolution in water, said indication being a substantial removal of color generated by said peracetic acid bleachable dye as recited in claim 1. The rejection under 35 U.S.C. § 112, first paragraph,3 is reversed. B. Obviousness The Examiner has rejected all of the claims on appeal as obvious based on the disclosures of Huth, Ignacio, Antonoplos, and Pegelow. The Examiner finds that Huth discloses “cleansing compositions which combine a per-compound oxidant as a decontaminating agent and enzymes, along 3 The Examiner asserts that “no indication of the basic and novel characteristics of the invention can be discerned from the disclosure, rendering it impossible for a skilled artisan to determine what potentially includable components would interfere.” Ans. 11–12. However, whether the Specification sufficiently identifies the basic and novel characteristics of the invention where the transitional phrase “consisting essentially of” is employed is an issue of definiteness resolved by the factfinder. See HZNP Medicines, 940 F.3d at 694. Appeal 2020-004217 Application 15/035,633 9 with any of chelators, buffers, dyes, and combinations thereof.” Ans. 7. The Examiner finds that Huth discloses all aspects of the composition except for the color change (removal of color) indicating “an initial achievement of a biocidally effective concentration of peracetic acid.” Id. at 8–9. The Examiner finds that Ignacio and Antonoplos disclose that sterilization monitors can “undergo distinct color changes in the presence of a peracetic acid” in a manner in which the concentration of the dye reflects the rate of removal of the oxidizing agent from the solution. Id. at 9–10. The Examiner further finds that Pegelow teaches that Amaranth (CI 16185) is an “exemplary dye capable of being oxidatively destroyed in the cleaning process.” Id. at 10–11. In light of these combined teachings, the Examiner concludes that the skilled artisan would have found the claimed subject matter obvious. Id. at 11. Appellant argues, among other things, that the claimed subject matter is not obvious because the central reference Huth “necessarily includes at least one enzyme and, yet, any inclusion of this enzyme component required by the teachings of Huth in the composition of Applicant’s claimed invention would materially affect its basic and novel characteristics.” Appeal Br. 12. Appellant argues that the enzyme disclosed in Huth acts to break down blood and other organic contaminants in or on medical instruments; a second enzyme recited in Huth acts to break down the decontaminating agent itself, e.g., PAA, which is necessarily removed in order to reuse the medical instrument after patient contact and disinfection. Id. Appellant argues that Huth discloses that “inclusion of the enzyme component necessarily affects and is necessarily affected by the inclusion of the decontaminating agent(s), e.g., H2O2 and/or PAA,” requires inclusion of Appeal 2020-004217 Application 15/035,633 10 additional components such as buffers to “limit the effects that the enzyme component and decontaminating agent(s) have on each other,” but that those components work “entirely differently than the claimed invention.” Id. at 12–14. Analysis As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): [T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability. . . . After evidence or argument is submitted by the applicant in response, patentability is determined on the totality of the record, by a preponderance of evidence with due consideration to persuasiveness of argument. In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007), although the Supreme Court emphasized “an expansive and flexible approach” to the obviousness question, id. at 415, it also reaffirmed the importance of determining “whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.” Id. at 418 (emphasis added). Thus, as the Federal Circuit has since explained, “obviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Ultimately, therefore, “[i]n determining whether obviousness is established by combining the teachings of the prior art, ‘the test is what the combined teachings of the references would have suggested to those of Appeal 2020-004217 Application 15/035,633 11 ordinary skill in the art.’” In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (citation omitted). We agree with Appellant that a preponderance of the evidence does not support the Examiner’s conclusion of obviousness. In particular, we are not persuaded that the teachings of Huth would have suggested to the skilled artisan that the chemical composition disclosed by Huth could be made without an enzyme, or that inclusion of the enzyme as taught by Huth would not affect the basic and novel characteristics of the claimed invention. Huth discloses “[a] composition for simultaneous cleaning and decontaminating a device. The composition is a per-compound oxidant in an amount effective for decontaminating the device and an enzyme in an amount effective for cleaning the device.” Huth Abstract (emphasis added). The “composition is a per-compound oxidant, such as hydrogen peroxide (H2O2) and/or peracetic acid (PAA) and an enzyme.” Id. ¶ 42. Huth discloses that an advantage of the invention is that it combines the “enzymatic detergent precleaning treatment with the decontaminating step so that cleaning and decontaminating are performed simultaneously.” Id. ¶ 51. Huth refers to the invention as “the combination of enzyme plus decontaminant.” Id. ¶ 54. In short, the invention of Huth requires the enzyme component to perform the cleaning step. Moreover, the amount of enzyme used in the solution must be “effective and efficacious” as described: An effective and efficacious amount is that which (1) removes, in a reasonable time a substantial portion of the proteinaceous or other deposits which occur during the use of the medical device, (2) does not decrease the efficacy of the decontaminating agent(s) when combined with the latter Appeal 2020-004217 Application 15/035,633 12 agent(s) in the working solution, and (3) allows the decontaminating agent(s) to achieve the standards, e.g., high- level disinfection and sterilization, required for the reprocessing of the particular device or instrument. Huth ¶ 78 (emphasis added). The amount of enzyme required depends on multiple factors, including: enzyme activity and purity, the amount of proteinaceous and other matter deposited, the desired soaking period and temperature, the nature and concentration of the decontaminating agent(s), the specific medical device or instrument, the delivery form of the enzyme and its related shelf stability, the presence of surfactants and other solution components known to enhance the activity of the particular enzyme. Id. ¶ 79. The decontaminant concentration directly affects enzyme concentration (see, e.g., Huth ¶ 81 “[e]nzyme activity loss from exposure to the decontaminant is greater with longer regimen soak times. Thus, these two effects need to be balanced in the final enzyme formula”; ¶¶ 82–86, discussing pH, temperature, enzyme activity loss, and dilution considerations in achieving correct concentration of enzyme and PAA); ¶ 204, reflecting loss of PAA concentration over time in solution with enzyme and organic matter. Because the enzyme must be balanced against PAA, the solution must be stabilized to avoid PAA entirely dissolving the enzyme. See, e.g., Huth ¶¶ 96–99 regarding balancing components to maximize concentration of hydrogen peroxide and minimize concentration of acetic acid to produce desired amount of peracetic acid for effective but minimally corrosive solution. We, therefore, disagree with the Examiner’s strict interpretation of Appeal 2020-004217 Application 15/035,633 13 paragraphs 78 and 79 of Huth as generally teaching that, in the compositions of Huth, “the enzyme does not interfere with the decontaminating agents with which they are to be combined.” Ans. 16. A composition where the enzyme does not interfere is only achieved where the composition has been carefully balanced with formulation of pH, temperature, stabilizers and enzyme dilution as described above, and that will permit the enzyme to cleanse and the peracetic acid to decontaminate such that, “the combined cleaning and decontaminating solutions of the present invention achieve significantly greater cleaning per unit of enzyme than prior stand-alone enzyme solutions,” which allows less enzyme to be used for cleansing. Id. ¶ 83. Some of these combinations are formulated as “single use” because application will exhaust one or more components (see e.g., Huth ¶¶152– 155). Notably, there is no teaching in Huth to use peracetic acid and color indicator dye without enzyme to perform decontamination. Rather, the cleaning enzyme and decontaminating components are explicitly stated as “[t]he two essential components.” Id. ¶ 136. Appellant states that, to overcome the rejection based on Huth, Appellant amended the claimed invention to recite “[a powdered composition] ‘consisting essentially of’” the listed components that did not include an enzyme. Appeal Br. 13–14. As noted by the Examiner and Appellant, “the [transitional] phrase ‘consisting essentially of’ limits the scope of a claim to the specified [materials or steps] ‘and those that do not materially affect the basic and novel characteristic(s)’ [of the claimed invention].” In re Herz, 537 F.2d 549, 551–52 (CCPA 1976). As described above, Huth teaches a carefully balanced cleaning and decontaminating Appeal 2020-004217 Application 15/035,633 14 solution that is balanced to permit a greater total benefit than each individual component. Therefore, we consider the enzyme (cleaning component), as an “essential component” to materially affect the “basic and novel characteristics” of the claimed composition. Because Appellant amended the claim to recite the transitional phrase “consisting essentially of,” without including an enzyme in the composition, and because Huth does not teach use of the composition without an enzyme, we are not persuaded that the skilled artisan would have found it obvious based on Huth to make the composition of claim 1. None of Antonoplos, Ignacio, or Pegelow are cited to teach use of the composition without an enzyme. We conclude that the Examiner has not met the burden to present a prima facie case of unpatentability, and we reverse the rejection of all claims. In re Oetiker at 1445. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 3, 6–8, 11– 15, 18 112 Written description 1, 3, 6–8, 11–15, 18 1, 3, 6–8, 11– 15, 18 103 Huth, Antonoplos, Ignacio, Pegelow 1, 3, 6–8, 11–15, 18 Overall Outcome 1, 3, 6–8, 11–15, 18 REVERSED Appeal 2020-004217 Application 15/035,633 15 CHANG, Administrative Patent Judge, concurring-in-part and dissenting- in-part While I agree with the Majority that a preponderance of evidence of record does not support the Examiner’s written description rejection, I respectfully dissent from the Majority’s opinion with respect to the reversal of the Examiner’s rejection under 35 U.S.C. § 103. A. Issue The Examiner rejects claims 1, 3, 6–8, 11–15, and 18 as obvious over Huth, Antonoplos, Ignacio, and Pegelow. Ans. 5. The Examiner finds that Huth teaches all of the limitations of claim 1, except that it does not explicitly disclose a composition “configured to generate and indicate an initial achievement of a biocidally effective concentration of peracetic acid upon dissolution in water” through the “substantial removal of color generated by said peracetic acid bleachable dye,” as required in claim 1. Ans. 7–8. Citing Ignacio and Antonoplos, however, the Examiner finds that this limitation merely describes “a difference in the amount of bleachable dye present in the composition relative to the quantity of peracetic acid to be generated from the peroxide and acetyl sources.” Id. at 8–10. The Examiner concludes that a skilled artisan would have found it obvious to modify the relative concentration of bleachable dye to oxidizing agent in Huth’s composition to arrive at the claimed composition, because “difference in concentration . . . will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration . . . is critical,” and “it Appeal 2020-004217 Application 15/035,633 16 is not inventive to discover the optimum or workable ranges by routine experimentation” where “general conditions of a claim are disclosed in the prior art.” Id. at 10.4 Appellant contends that the prior art does not suggest a composition consisting essentially of the explicitly recited components, as required by claim 1. Appeal Br. 11–15. Appellant further contends that the cited prior art combination does not suggest the limitation of a composition “configured to . . . indicate an initial achievement of a biocidally effective concentration of peracetic acid upon dissolution in water, said indication being a substantial removal of color generated by said peracetic acid bleachable dye.” Id. at 15–17. Appellant does not separately argue the claims. I therefore focus my analysis on claim 1 as representative. The issues with respect to this rejection are (1) whether a preponderance of the evidence of record supports the Examiner’s finding that the prior art combination suggests a composition consisting essentially of the explicitly recited components of claim 1, and (2) whether a preponderance of evidence of record supports the Examiner’s finding that the prior art combination suggests a composition “configured to . . . indicate an initial achievement of a biocidally effective concentration of peracetic acid.” 4 The Examiner further cites Pegelow for the specific hydrogen peroxide source and dye recited in certain dependent claims. Ans. 10–11. Appeal 2020-004217 Application 15/035,633 17 B. Analysis 1. “consisting essentially of: (a) a hydrogen peroxide source; (b) an acetyl source; and (c) a peracetic acid bleachable dye” As the Majority explained in its opinion, the phrase “consisting essentially of” is a transition phrase that, when used before a list of ingredients in a composition claim, indicates that “the invention necessarily includes the listed ingredients [but] is open to unlisted ingredients that do not materially affect the basic and novel properties of the invention.” HZNP, 940 F.3d at 692–693. Furthermore, Appellant has the burden of showing that the additional ingredient taught by the prior art reference materially affects the basic and novel characteristics of the claimed invention. See In re De Lajarte, 337 F.2d 870, 874 (CCPA 1964). Appellant asserts that the “basic and novel properties” of its invention are “(1) The generation of a biocidally effective concentration of peracetic acid (‘PAA’) . . . ; and (2) The indication of an initial achievement, i.e., the temporal onset, of a biocidally effective concentration of PAA.” Appeal Br. 7; see also Reply Br. 3, 7–8. Accordingly, based on Appellant’s own identification of the “basic and novel properties” of its invention, the dispositive question with respect to the obviousness rejection is whether Appellant has shown that the composition suggested by the cited prior art combination includes ingredients that materially affect either the generation of a biocidally effective concentration of PAA or the indication of the initial Appeal 2020-004217 Application 15/035,633 18 achievement of a biocidally effective concentration of PAA. I agree with the Examiner that Appellant has not met this burden. Ans. 15. Appellant contends that Huth is “directed to a . . . composition [that] includes a per-compound oxidant (such as H2O2 and/or PAA) and an enzyme” and/or “a multi-component composition including at least one enzyme, a chelating agent, and a buffer.” Appeal Br. 11–12, 13. Appellant contends that “any inclusion of this enzyme component required by the teachings of Huth in the composition of Applicant’s claimed invention would materially affect its basic and novel characteristics.” Id. at 12; see id. at 13 (asserting that “the enzyme of Huth works in a contrary manner to the use of PAA as a surface decontaminant”). Assuming for the sake of argument that Huth does not suggest a claimed composition without inclusion of an enzyme,5 I am not persuaded that the enzyme in Huth materially affects either the generation of a biocidally effective concentration of PAA or the indication of the initial achievement of such a concentration. As an initial matter, Appellant does not appear to suggest in the Appeal Brief that the enzyme would interfere with the function of a dye or other similar indicators. Thus, I understand 5 I note that Huth teaches that “dyes may be added to either the separate cleaning formula, a separate decontaminant formula, both separate formulas or to a combined cleaning plus decontaminant formula to differentiate the formula from water or other reprocessing solutions.” Huth ¶ 129. Thus, Huth appears to at least suggest a composition comprising a dye and a decontaminant formula without the inclusion of an enzyme. Appeal 2020-004217 Application 15/035,633 19 Appellant’s argument to be focused on the characteristic of “the generation of a biocidally effective concentration of PAA.”6 Appellant first contends that “[o]ne enzyme recited in Huth acts to break down blood and other organic contaminants in or on medical instruments; a second enzyme recited in Huth acts to break down the decontaminating agent itself, e.g., PAA, which is necessarily removed in order to reuse the medical instrument after patient contact and disinfection.” Appeal Br. 12; see also id. at 13–14 (asserting that, “[b]ased on the full disclosure of Huth, there is no doubt that, in order to be employed effectively and according to its intended purpose, the composition of Huth requires at least one, likely two, enzymes in addition to a chelating agent and a buffer so that the PAA decontaminating agent may also be included”) (emphasis added). Appellant contends that “breaking down the PAA by 6 In the Reply Brief, Appellant contends for the first time that “Huth requires stated enzymes to function . . . and those enzymes described by Huth counteract the disinfectant and color changing aspects of the disclosed invention.” Reply Br. 9 (emphasis added). Appellant provides no argument or support as to how the enzymes in Huth counteract the “color changing aspects of the disclosed invention.” Moreover, Appellant has not explained why such an argument could not have been raised in the Appeal Brief. Hence, the argument has been waived. See Ex parte Nakashima, 93 USPQ2d 1834 (BPA1 2010) (informative) (arguments and evidence not timely presented in the Principal Brief will not be considered when filed in a Reply Brief, absent a showing of good cause explaining why the argument could not have been presented in the Principal Brief); Ex parte Borden, 93 USPQ2d 1473, 1477 (BPA1 2010) (informative) (explaining that “the Rules do not require the Board to take up a belated argument that has not been addressed by the Examiner, absent a showing of good cause”). Appeal 2020-004217 Application 15/035,633 20 Huth is directly contrary to the present invention, which decontaminates by using PAA as the agent for the same on surfaces.” Id. at 12. I am not persuaded. Appellant does not cite to any portion of Huth that supports its contention that Huth requires an enzyme that breaks down the PAA. “Attorneys’ argument is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989). In fact, Huth teaches “unique device reprocessing steps employing a bulk soil removal rinsing step, followed by a simultaneous cleaning and decontaminating step employing a per-compound oxidant and an enzyme, and a last rinsing step to remove the oxidant and enzyme solution from the device.” Huth ¶ 52. Thus, contrary to Appellant’s assertion, the decontaminating agent in Huth appears to be removed by rinsing rather than enzymatic breakdown. Appellant does cite to paragraphs 78–79 of Huth for the proposition that “inclusion of the enzyme component necessarily affects and is necessarily affected by the inclusion of the decontaminating agent(s), e.g., H2O2 and/or PAA and, thus, additional components are required to limit the effects that the enzyme component and decontaminating agent(s) have on each other.” Appeal Br. 12; see also Reply Br. 10–11 (alleging that Huth paragraphs 78–79 teaches the “negative impact of enzyme and decontaminating agent, e.g., PAA, on each other”). The cited paragraphs do not support Appellant’s argument. While paragraph 79 of Huth does teach that “[t]he precise amount of enzyme required . . . will depend on several factors including . . . the nature and concentration of the decontaminating agent(s),” this general teaching does not suggest that the enzyme will interfere with or materially affect the Appeal 2020-004217 Application 15/035,633 21 generation of a biocidally effective concentration of a decontaminating agent. Indeed, paragraph 78 teaches the opposite – that Huth’s invention generally employs “an effective and efficacious amount of enzyme to clean the device or instrument” and that this amount is “that which . . . does not decrease the efficacy of the decontaminating agent(s) when combined with the latter agent(s) in the working solution[] and . . . allows the decontaminating agent(s) to achieve the standards, e.g., high-level disinfection and sterilization[] required for the reprocessing of the particular device or instrument.” In short, these paragraphs teach that the amount of enzyme in Huth’s composition is one that will not materially affect “the generation of a biocidally effective concentration” of decontaminating agents such as PAA. Appellant further cites to paragraph 48 of Huth as describing the inactivation of enzymes by PAA and paragraph 52 of Huth as describing “destabilization of the decontaminating agent by contact with blood and trace metals,” which Appellant contends to be the intended purpose of Huth. Appeal Br. 12–13; see also Reply Br. 10. Citing these paragraphs, Appellant contends that, “[i]n order to permit the competing decontaminating agent and enzyme of Huth to effectively coexist in the composition, Huth requires the additional inclusion of ‘a unique chelating agent and/or buffer,” where “[t]he chelating agent in the proper concentration prevents destabilization of the decontaminant due to contact with blood and trace metals” and “the buffer ‘provides adequate buffering capacity for a large volume of decontaminant during multiple device processing cycles.’” Appeal Br. 13; see also Reply Br. 10–11. Appeal 2020-004217 Application 15/035,633 22 I am not persuaded. While paragraph 48 may suggest that PAA may inactivate certain cleaning enzymes, it does not suggest the opposite. Because it is the generation of a biocidally effective concentration of PAA rather than the enzyme that is the alleged basic and novel property of the invention, the cited paragraph does not preclude the prior art composition suggested by Huth and other cited prior art from reading on claim 1. Appellant’s citation to paragraph 52 is similarly inapposite. That paragraph lists as an advantage of Huth’s composition that it is reusable because of “the incorporation of a combination of enzyme plus decontaminant plus a unique chelating agent and/or buffer.” Huth teaches that the buffer “provides adequate buffering capacity for a large volume of decontaminant during multiple device processing cycles.” Huth ¶ 52. It also teaches that “[t]he chelating agent in the proper concentration prevents destabilization of the decontaminant due to contact with blood and trace metals.” Id. While Appellant is correct that paragraph 52 teaches that the decontaminant in Huth’s composition may be destabilized due to contact with blood and trace metals when used to clean medical instruments such as endoscopes, Appeal Br. 12–13, and not withstanding Appellant’s emphasis that such use is the “intended purpose” of Huth’s composition, id., this is irrelevant to whether the composition taught by Huth includes any ingredient that materially affects the basic and novel properties of the invention, because blood and trace metals are not part of Huth’s composition.7 7 In this regard, I note that claim 1 is to a composition rather than a method of use. For this reason, I am similarly unpersuaded Appellant’s arguments Appeal 2020-004217 Application 15/035,633 23 Finally, Appellant does not point to any specific teaching in paragraphs 48 and 52, or elsewhere in Huth, that the chelating agent and/or buffer is required “[i]n order to permit the competing decontaminating agent and enzyme of Huth to effectively coexist in the composition.” Appeal Br. 13. As discussed above, the purpose of the chelating agent in Huth is to prevent destabilization of the decontaminant due to contact with blood and trace metals. Likewise, paragraphs 48 and 52 of Huth both suggest that the purpose of the “unique chelating agent and/or buffer” is to create a reusable decontaminating and cleaning solution. Huth, however, also clearly teaches a single-use solution. Huth ¶ 48; see also id. at Abstract (“The composition may additionally contain a corrosion inhibitor . . . , a chelator, a buffer, a dye and combinations thereof.”) (emphasis added).8 Appellant appears to contend that the Examiner engaged in “impermissible hindsight to pick and choose only one or two of the components of Huth relevant to the claimed invention for purposes of . . . the present prior art rejection.” Appeal Br. 13; see also id. at 14 (“The to the extent they are based on a particular use of the claimed composition. See, e.g., Appeal Br. 13 (arguing that “the enzyme of Huth works in a contrary manner to the use of PAA as a surface contaminant”) (emphasis added); 14 (arguing that the “consisting essentially of” language “captures the truly critical components of the claimed composition and associated impact on the use of PAA in a surface disinfecting composition) (emphasis added). 8 Assuming that the chelating agent and/or buffer is required in Huth’s composition, Appellant appears to agree that the chelating agents and buffers, in and of themselves, do not “interfere with the basic and novel characteristics of the invention claimed.” Reply Br. 11. Appeal 2020-004217 Application 15/035,633 24 Examiner turns a blind eye toward the teachings of Huth in order to cherry- pick out only the PAA-producing components, willfully ignoring the vital presence and role of the enzymes, the chelating agent, and the buffer”), Reply Br. 12. Appellant also contends in the Reply Brief that the obviousness rejection should be reversed because the Examiner explicitly and improperly construed “consisting essentially of” as equivalent to “comprising.” Reply Br. 10. I am not persuaded because the Examiner provided an alternative basis for the rejection, namely that “even if Appellant’s disclosure would support such an intermediate interpretation of claim scope—i.e., “consisting essentially of” construed as excluding ingredients that materially affect the basic and novel properties of the invention—“nothing in Huth would in fact interfere with either the generation of peracetic acid or of the peracetic acid bleaching of oxidizable dye combined with the peracid-generating components.” Ans. 15. As discussed above, I agree that Appellant has not shown that the enzyme, chelator, and/or buffer materially affect these alleged basic and novel properties of the claimed invention. 2. “configured to . . . indicate an initial achievement of a biocidally effective concentration of peracetic acid” Appellant contends that the cited combination of prior art does not suggest a composition “configured to . . . indicate an initial achievement of a biocidally effective concentration of peracetic acid.” In particular, Appellant contends that “[i]n Huth, the indicator signals the end of the disinfection period, and not the initial presence of a biocidally effective concetration of PAA, as in Applicant’s invention.” Appeal Br. 15. Appellant contends that Appeal 2020-004217 Application 15/035,633 25 both Antonoplos and Ignacio likewise teach “indicators designed to indicate that the disinfection conditions were met, rather than showing an initial concentration has been reached” and are further “directed towards specific indicator systems or devices that are external to the composition, rather than integral with the composition, as in Applicant’s invention.” Id. I am not persuaded. Although Huth teaches using indicator dyes to “serve as an indicator of completion of the required decontamination soak time,” Huth also teaches that colorants may also be incorporated into Huth’s formulations to “indicate the presence or absence of H2O2 or PAA or other peroxides.” Huth ¶ 130. Furthermore, Ignacio teaches that, “[d]uring a typical sterilization cycle, the instruments being sterilized are exposed to a sterilization solution containing, for example about 200 ppm or 2500 ppm of peracetic acid.” Ignacio 1:15–18. Ignacio further teaches “a method of determining whether a solution including peracid has a concentration of peracetic acid of about 2500 ppm,” i.e., a biocidally effective concentration of peracetic acid, wherein “[a] monitor composition is exposed to the peracetic acid solution under conditions that will cause the monitor composition to undergo a color change at about 2500 ppm of peracetic acid.” Id. at 2:1–6. In light of these teachings, I agree with the Examiner that a skilled artisan would have had a reason to incorporate into Huth a dye that indicates the presence of a biocidally effectively concentration of HAA. For these reasons, I am also not persuaded by Appellant’s argument that Ignacio Appeal 2020-004217 Application 15/035,633 26 does not teach indicators designed to indicate “an initial achievement of a biocidally effective concentration of peracetic acid.” Finally, I am unpersuaded by Appellant’s criticism that Antonoplos and Ignacio do not teach an indicator integral with the composition. “Non- obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Furthermore, “[t]he test for obviousness is not whether the features of one reference may be bodily incorporated into another reference. Rather, we look to see whether combined Teachings render the claimed subject matter obvious.” Application of Wood, 599 F.2d 1032, 1037 (CCPA 1979). In this case, Huth teaches an indicator integral with the composition, and the combination the cited prior art renders claim 1 obvious for the reasons discussed above. Appellant contends in the Reply Brief that “it is factually incorrect to assert that Huth teaches or suggests the presence of a bleachable dye in a composition in which a quantity of peracetic acid is generated from a hydrogen peroxide source and an acetyl source, with the dye color dissipating upon the initial presence of a sufficient PAA concentration for use as an effective disinfectant.” Reply Br. 12–13. Appellant does not provide any explanation as to how, much less why, the statement is factually incorrect. In the Reply Brief, and in the context of responding to the Examiner’s written description rejection, Appellant further argues that “the indicator dye mechanism of Huth is distinct in composition and function Appeal 2020-004217 Application 15/035,633 27 from that of the claimed invention and, if anything, is completely opposite in its operation” for a variety of reasons. Reply Br. 5–7. To the extent Appellant’s argument is that the prior art only teaches “indicators designed to indicate that the disinfection conditions were met” rather than “the initial presence of a biocidally effective concentration of PAA,” I am not persuaded for the reasons already discussed. Appellant has waived additional arguments on this issue with respect to the obviousness rejection, because they were not raised in the Appeal Brief, and Appellant has not shown good cause why such arguments could not have been raised therein. See Ex parte Nakashima, 93 USPQ2d 1834; Ex parte Borden, 93 USPQ2d at 1477. Finally, Appellant contends that, “[a]s further evidence of the inventiveness and/or nonobviousness of Applicant’s claimed composition, Applicant notes that counterpart foreign applications have been allowed around the world, with broader independent claims and having considered the same art as before the USPTO, particularly Huth and Pegelow.” Appeal Br. 17–18; see also Reply Br. 13. The decisions of foreign patent offices, however, are not binding on the Board, and, as discussed above, I do not find Appellant’s arguments on this record persuasive. Accordingly, for the reasons discussed above, I would affirm the Examiner’s rejection under 35 U.S.C. § 103. Copy with citationCopy as parenthetical citation