DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1, 4-12, and 15-22 are pending, presented for examination and rejected as set forth in greater detail below.
Claim Interpretation
Applicants’ claim 1 is directed to a method of preparing a solution by dissolving in water a single-part powder compositions “consisting essentially of” a hydrogen peroxide source, an acetyl source, and a 1-arylazo-2-hydroxynapthyl dye which generates an initial color that is removed when a biocidally effective concentration of peracetic acid, specifically one in excess of 0.14% of the solution, is obtained, which the skilled artisan would understand represents the removal of a dye color through its bleaching by peracetic acid. Understanding the scope of the compositions addressing these limitations requires an understanding of what is permitted, and excluded, from the composition claimed. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976) (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). Understanding the breadth of components permissibly includable in this composition is aided by the consideration of the remaining claims which depend from Claim 1, because applicants are aware that dependent claims necessarily include every limitation of the claim from which it depends and specifies further limitations of the subject matter being claimed. MPEP 608.01(n)(III). It is helpful in this context to look to the limitations of Claim 10, in which applicants specify that the compositions of Claim 1 may permissibly incorporate any of acidifying agents, wetting agents, pH buffering agents, sequestering agents, flow modifiers, perfumes, additional dyes, or combinations thereof. These additional components are defined by the activities they contribute to the compositions into which they have been included. See, e.g., Specification pages 14-16 (“A wetting agent may be included in the composition to facilitate dispersion of the acetyl source into solution…preferably comprised of a solid surfactant capable of lowering the surface tension of the solvent…”, “A flow modifier may be added to improve the flow characteristics of the composition of the invention….”). “A patent applicant is free to recite features of an apparatus either structurally or functionally . . . Yet, choosing to define an element functionally, i.e., by what it does, carries with it a risk.” In re Schreiber, 128 F.3d 1473, 1477-78 (Fed. Cir. 1997) (once the Examiner finds that the prior art structure would be capable of performing all of the functions claimed, the burden shifts to the applicant to show this this is not the case). Art describing the use of components a skilled artisan would understand provide these functions or properties to the consumer products into which they have been incorporated will be considered as suitably addressing the limitations imposed on Claim 1 by Claim 10. Claims 4 and 5 narrow the identity of the dye of Claim 1 to Amaranth. Claims 6 & 7 narrow the identity of the peroxide source to, among others, sodium percarbonate. Claims 8 & 9 narrow the identity of the acetyl source to, among others, tetraacetylethylenediamine (TAED). Claim 11 indicates that the time in which the color is to be dispersed is approximately 10 minutes. As this reflects the rate at which the peracetic acid bleachable dye is to be consumed by the peracetic acid being generated, the Examiner understands this to reflect the inclusion of a defined amount of dye which will be consumed by the peracetic acid being generated.
Claim 12 indicates that the composition used in the method of generating an effective concentration of peracetic acid in solution is one which “consists of” a hydrogen peroxide source, an acetyl source, a peracetic acid bleachable dye, and optionally any of acidifying agents, wetting agents, pH buffering agents, sequestering agents, flow modifiers, perfumes, additional dyes, or combinations thereof. Again, Applicants are reminded that during examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005). While on its face a claim “consisting of” a list of required elements might appear narrow, the entirety of the claim must be taken into consideration under the prevailing legal standard, including the potential inclusion of any elements recited as “optional.” Therefore, art which requires only a combination of peroxide source, an acetyl source, a peracetic acid bleachable dye, wetting agents, and flow modifiers will in fact address even the composition “consisting of” the elements required by Claim 18. Claims 15-20 parallel the limitations set forth in claims 4-11 in a narrower manifestation of the method. Claims 21 and 22 reflect methods of using the solutions generated in Claims 1 and 12, respectively, to disinfect an object.
Response to Amendment
The declaration of inventor Dr. Glasbey under 37 CFR 1.132 filed 9 July 2026 is insufficient to overcome the rejection of claims 1, 4-12, and 15-22 based upon the combined teachings of Badertscher, Wei, Antonoplos, Ignacio, and Pegelow as set forth in the last Office action because the evidence discussed is that which has previously been presented in the specification as filed. Therefore, nothing of the evidence discussed in the declaration has not already been considered by the Examiner and already deemed unpersuasive. Furthermore, nothing of the data discussed rises to the level of overcoming the presumption of operability and reasonable expectation of success the skilled artisan would possess concerning the ability to combine the art of record to obtain applicants invention.
Declarant discusses the “unexpected challenges” faced by applicants in their particular formulation of a peracetic acid generating disinfecting system containing an indicator dye, presented as sections 8-10 of the declaration. Declarant does not actually present evidence tending to establish that, at the time the instant application was filed, a person of ordinary skill in the art would have faced challenges or an unpredictable field of endeavor in choosing an alternative indicator dye system to those explicitly available in the prior art. Applicants are reminded that obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness). Here, Declarant indicates that while the prior art in fact provides disinfectant systems which provide a color change when a desirable level of peracetic acid has been obtained, the particular “colour scheme for the product does leave a lot to be desired,” and then goes on to assert, without evidence, that an alternative color scheme would be preferable, or more aesthetically pleasing. (Pg.3). It has long been held that such aesthetic design changes, which impart no distinction to the functioning of the product in question, cannot be relied upon to patentably distinguish a claimed invention from the prior art. See In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947). Applicants assert that a decrease in the time needed to achieve an effective peracetic acid concentration at 20C represents applicants addressing a long felt need in the art. Applicants are reminded that establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. In re Gershon, 372 F.2d 535, 539, 152 USPQ 602, 605 (CCPA 1967). Second, the long-felt need must not have been satisfied by another before the invention by applicant. Newell Companies v. Kenney Mfg. Co., 864 F.2d 757, 768, 9 USPQ2d 1417, 1426 (Fed. Cir. 1988). Third, the invention must, in fact, actually satisfy the long-felt need. In re Cavanagh, 436 F.2d 491, 168 USPQ 466 (CCPA 1971). Here, neither evidence tending to establish the persistent existence of a need recognized by one of skill in the art, nor of any indication that no other solution has been provided, can be found of record. For at least these reasons, Declarant’s assertion the invention claimed satisfies a long-felt need is unpersuasive.
Declarant’s discussion of the relative stability of peracetic acid bleachable dye in hydrogen peroxide alone, versus a combination of peroxide and peracetic acid appears irrelevant to the question of obviousness on the record at present. The art relied on by the examiner does not rely on peroxide alone as a disinfecting agent, but rather points to art from 1992 to establish the existence of single-part powder compositions used to generate peracetic acid in solution, and art available between 2001-2007 to establish the use of dyes including the instantly claimed amaranth as color-changing indicators of desired peracetic acid concentrations in solution.
Applicants discussion of peracetic acid concentration generation measured at 10, 20, and 30 minutes, asserting that each of stirring and increased reaction time contributed to the achievement of a biocidally effective peracetic acid concentration is of little value. This is because each of stirring reactants and increased reaction times have long been known to assist in the dissolution of and therefore reaction between reactants in solution. See In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (indicating that "[a]n assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.").
Declarant’s discussion of the 10,660,338 patent in terms of unpredictability of the art is likewise unpersuasive. Applicants assertion that the ‘338 compositions achieve color changes as a result of time rather than as a result of peracetic acid concentrations is both factually inaccurate and irrelevant. Inaccurate in that the claim quoted by applicants specifically states the compositions include “a colour indicator arranged to provide a first colour signal when the concentration of peracetic acid is lower than about 1000ppm and a second colour signal when the concentration is higher than about 1000 ppm.” (Declaration, sec. 17). This explicitly states the color indicators act in response to peracetic acid concentrations. In addition, the ‘338 patent provides a composition which combines the peroxy compound and peroxy activator as well as the color indicator. These react to generate peracetic acid which activates the color change recited. Any changes between the ‘338 patent and the instant application in language used to describe these systems amount to a distinction without a difference, in that they each describe the same reactant systems used to generate peracetic acid and indicate when desired peracetic acid concentrations have been achieved. That the ‘388 patent may be silent as to the bleaching effect being attributable to peroxide or peracetic acid is irrelevant in view of the substantial similarity between reactants required by each.
For at least these reasons, the Glasbey declaration is unpersuasive.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-12, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Badertscher (U.S. 5,116,575), in view of Wei (6,319,888), Antonoplos (U.S. 6,551,555), Ignacio (U.S. 6,287,518), and Pegelow (U.S. PGPub. 2007/0197416).
Badertscher describes powders containing a water-soluble acid precursor and a water soluble peroxy compound, used to form antimicrobial agents when combined with water. (Col.1, L.13-20; Col.2, L.45-52). Badertscher indicates that the TAED of the present claims is known to be useful in such compositions as an acid precursor component combined with hydrogen peroxide releasing agents. (Col2, L.21-31). Badertscher indicates these compositions are configured to provide peracetic acid in solution, when combined with water, in concentrations of 0.2%, which is greater than the claimed 0.14% to render the present claims obvious. (Col.2, L.57-8), see In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Sodium perborate of the present claims is recited as an exemplary peroxide compound. (Col.2, L.55-68). Badertscher indicates that wetting agents of the present claims may optionally be included. (Col7, L.3-8). Badertscher indicates that these compositions may be used by dissolving them in water, and then exposing surfaces to be disinfected with the resultant solution. (Col.4, L.35-37; 57-60)
While explaining the utility of powdered compositions combining acid precursors such as TAED with peroxy compounds in forming disinfecting compositions by their dissolution in water and subsequent contact with surfaces to be disinfected, Badertscher does not recite the sodium percarbonate of the present claims as a peroxy compound, nor is the inclusion of an acid bleachable dye recited as an indicator of when the solution formed has achieved the desired peracetic acid concentration.
Wei also describes peracid forming compositions combining a peracid precursor and a peroxygen source. (Col.2, L.50-54). Wei describes these compositions as simple mixtures of components which generate peracid solutions when hydrated. (Col.3, L.31-2; 55-6; Col.5, L.3-10; 48-54; Col6, L.52-55). Wei indicates that components other than the peracid precursor and peroxygen source may be included in the peracid forming compositions. (Col.6, L.12-16). Each of the presently claimed sodium perborate and sodium percarbonate are recited as peroxygen sources. (Col.9, L.10-12).
The art therefore establishes that the skilled artisan was aware combining solid peracid precursors such as the presently claimed TAED with solid peroxygen sources such as the presently claimed sodium percarbonate to provide a single powder composition which could reliably remain stable during storage to provide, upon combination with aqueous media, disinfecting peracid solutions having peracid concentrations of about 0.2% to then be used in methods of disinfecting surfaces.
The difference between the powdered peracetic acid precursor compositions suggested by Badertscher and Wei and the instant Claims lies in the fact that the claimed composition is one which achieves a substantial removal of color generated by said peracetic acid bleachable dye when a particular peracetic acid concentration is reached, which in dependent claims is identified as a particular peracetic acid concentration achieved after a certain period of time. In view of the art available at the time the instant application was filed, the Examiner considers this merely a functional description of including an amount of bleachable dye in the composition relative to the quantity of peracetic acid to be generated from the peroxide and acetyl sources. This interpretation is supported by the teachings of Ignacio, which describes sterilization monitors used in sterilization processes employing peracids to advantageously establish various desired endpoints in sterilization processes. (Col.1, L.24-35, L.59-67; Col.2, L.45-52). Ignacio establishes that in the context of sterilization compositions, monitors, and more specifically sterilization monitors which undergo distinct color changes in the presence of a peracetic acid, (Abs., Col.2, L.46-52), “the quantity of dye in the composition also will influence the rate at which the composition undergoes the distinct color change.” (Col.3, L.26-28). This color change may explicitly be employed to determine whether particular concentrations of peracetic acid have been achieved, (Col.2, L.1-6), or after a certain period of time has passed, including particularly mentioned times of 5 or 15 minutes, defining a range encompassing and therefore rendering obvious the ten minutes of the instant claims. (Col.2, L.65 – Col.3, L.4), see Peterson, supra. This understanding is augmented by the teachings of Antonoplos, which, again in the context of methods of employing sterilization monitors which change color upon exposure to an oxidative sterilant (Abs., Col.2, L.6-9), explicitly reminds the skilled artisan that each of exposure time, the quantity of oxidant used (Col.5, L.43-51; Col.7, L.31-35), and the concentration of dye present in the composition effect the rate at which the color the dye represents is removed from solution. See (Col.7, L.35 – Col.8, L.4) (indicating that “the concentration of dye will alter the degree of bleaching that occurs when the dye is exposed to an oxidation-type sterilant. Use of a high concentration dye mixture decreases the rate of color change. Applying dye in a low dye concentration mixture increases the rate of color change.”) As such, the skilled artisan would understand that adjusting the amount of bleachable dye present in a sterilizing and indicator system relative to the amount of oxidizing agent would decrease the time from mixing at which the color change would occur, coinciding, should the artisan choose, with a point at which a particular peracetic acid concentration is achieved following the suggestions of Ignacio. Armed with this understanding, applicants language indicating the solution achieves a substantial removal of color generated by said peracetic acid bleachable dye when a particular peracetic acid concentration is reached simply represents a modification of the concentration of bleachable dye present in the composition relative to the oxidizing agent present, and is therefore an obvious modification of the teachings of the Badertscher and Wei references. As the physical manifestation of the functional language describing the compositions of the instant claims arises from the difference in relative amounts of peroxide/acetyl source and the bleachable dye present in the compositions, applicants’ compositions, by this recitation, simply encompass a greater redox pair/dye concentration, so that an excess of oxidant will remain or continue to be generated after sufficient oxidant has oxidized the quantity of bleachable dye present. Given the art of record this is prima facie obvious because generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Neither Badertscher, Wei, Ignacio, nor Antonoplos specifically recite Amaranth as the indicator dye capable of being decomposed on exposure to the oxidant-based decontaminant.
Pegelow describes granulated materials, which the examiner considers sufficiently analogous to the instantly claimed “powder composition,” containing a bleach activator in combination with, among others, bleaching agents, dyes, and additional components. (Abs.). Sodium percarbonate powder is described as an exemplary agent providing an oxidizing bleaching action. [0153-55]. Each of E110 Sunset Yellow; food Yellow 3 (15985) (, [ 0195], and Amaranth (CI 16185) are each described as exemplary dyes capable of not only being included as colorants in disinfecting dye compositions, but also of being oxidatively destroyed by the formation of peracids from precursors with which they are combined. [0165-69]. Fragrances ([0229]), surfactants ([0114]), builders ([0075]) and co-builders ([0090]), may also be included in the granulated materials described.
It would have been prima facie obvious to one having ordinary skill in the art at the time of the instant invention to have combined sodium percarbonate powder with solid peracid precursors such as TAED and optional wetting agents to provide a solid disinfecting composition powder as described by Badertscher and Wei, and as obvious to have incorporated the Amaranth taught by Pegelow through the teachings of Ignacio and Antonoplos as an indicator dye in the disinfecting compositions suggested by Badertscher and Wei. It furthermore would have been obvious to have then dissolved such a single part powder composition in water and then waited until the dye has been removed to indicate the solution is ready for use as a disinfectant, then applied such a solution to the surface of an object to be disinfected. One having ordinary skill in the art would have been motivated to do so because the strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95 (Fed. Cir. 1983). Here, Badertscher and Wei teach the solid granular disinfecting compositions of the instant claims to be dissolved in water and used as a disinfecting solution, but for the recitation of an indicator dye such as Amaranth and a particular peroxide source as sodium percarbonate. The teachings of Ignacio, Antonoplos, and Pegelow establish that including indicatory dyes such as Amaranth into peracid containing disinfecting compositions serves to establish a point at which a desired concentration of peracid disinfectant has been achieved. As has been explained above, the composition being one which indicates the solution achieves a substantial removal of color generated by said peracetic acid bleachable dye when a particular peracetic acid concentration is reached simply describes an amount of dye which functions to establish that a certain concentration of peracid has been produced by the peracid precursors Badertscher and Wei teaches provide the disinfecting capacity of the compositions described. The skilled artisan would understand that these dyes would be oxidatively destroyed in the process of peracid precursors reacting to form peracids to provide what applicants consider, and which each of Badertscher and Wei and Ignacio render obvious, to be biocidally effective concentrations of peracids, simply by including an amount of bleachable dye which would be consumed when the peracid concentration reaches the effective peracid concentrations taught by Badertscher and Wei and Ignacio. This is an explicit goal which Ignacio teaches the inclusion of such dyes are to provide. See Ignacio, Col.2, L.1-6.
Response to Arguments
Applicant's arguments filed 9 July 2026 have been fully considered.
Applicants assertion that Seelow fails to address certain claim aspects is unpersuasive, as Pegelow has not been relied on to establish these Claim limitations were known or obvious. Pegelow is relied on simply to establish that the amaranth claimed was a peracetic acid bleachable dye suitable for use as an indicator dye for use with peracetic acid disinfecting compositions.
Applicants arguments concerning the Ignacio and Antonoplos references fail to persuade for similar reasons. Neither Ignacio nor Antonoplos are relied on to establish the disinfecting components of the disinfecting system, but rather to establish that relative quantities of dye to peracid generating compounds influences the rate at which the composition undergoes a color change. Applicants arguments concerning the particular use of these indicators by Ignacio fails to detract from the knowledge conveyed to the skilled artisan, as the Patent Trial and Appeal board held on at least pages 17-19 in their opinion of 1 December 2025 in the related 15/035,633 application.
Applicants arguments reiterating the issues raised in the Glasbey Declaration have been addressed above and will not be repeated here.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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