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 .
Priority
The instant application, filed 06/16/2022, claims priority to U.S. provisional application 63/213,755, filed 06/23/2021.
Preliminary Amendments and Claim Status
The preliminary amendment filed on 08/11/2025 is acknowledged and entered.
Claim 1 is amended. Claim 20 is new. Claims 1-20 are pending and examined.
Response to arguments
Applicant’s arguments filed 08/11/2025 with respect to the rejections under 35 U.S.C. § 103 have been fully considered.
With respect to the 35 U.S.C. § 103 rejection of claims 1-5 and 7-19 as being unpatentable over Stulens (U.S. Patent Application Publication No. 2002/0175092A1, published 28 November 2002). Applicant arguments filed 08/11/2025 are herein addressed as follows.
Applicant argues that the instant specification, filed 06/16/2022, contains evidence of unexpected results which overcome the prima facia case of obviousness demonstrated by examiner. Applicants cite to tables to 2 and 3 of the instant specification as providing evidence of unexpected results. These tables are reproduced below:
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Applicants allege that the formulations of Table 2 and antiviral efficacy thereof reported in Table 3 provide evidence of secondary considerations sufficient to overcome the prima facie case of obviousness.
Examiner disagrees. The burden of demonstrating a secondary consideration such as unexpected results belongs to Applicants. According to MPEP § 716.02 (b) (I)
I. BURDEN ON APPLICANT TO ESTABLISH RESULTS ARE UNEXPECTED AND SIGNIFICANT
The evidence relied upon should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength “are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration.”); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).
With respect to the case law citation, the practical significance of the data is not demonstrated by the comparative examples, nor the arguments of Applicant’s counsel. According to Table 2, Applicant’s compositions #1-3 have a significantly lower pH than that of the Comparative compositions #4-6, owning to the significantly lower acid concentration, and total lack of citric acid salt, sodium citrate in the Comparative compositions. Additionally, the weight percentages of the quaternary ammonium compounds of Applicant’s composition #1-3 are only comparative with a single composition (Comparative composition #6). The combined effect of a total lack of buffering salt, and significantly lower acid concentration within the compositions, means that there are at least two variables which could contribute to the alleged unexpected result. According to MPEP § 716.02 (b) (II), Applicant must offer an explanation of said data, and explain why the results are unexpected.
II. APPLICANTS HAVE BURDEN OF EXPLAINING PROFFERED DATA
“[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness.” Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992).
Applicants have provided data which Applicants allege to contain unexpected results. Examiner disagrees that these results are sufficient to meet Applicant’s burden because Applicants have not explained why the results are unexpected and the results do not appear to be commensurate in scope with the instant claims. Specifically, even the narrowest claim presently presented, newly added claim 20 requires that the composition has an antiviral activity of at least 1 on a non-enveloped and enveloped virus at pH ranges of 3-6. The data of Table 3 demonstrate that at a pH of 4 and 3, the composition is not capable of achieving antiviral activity of at least 1 on a non-enveloped and enveloped virus. Therefore, the data is not commensurate in scope with the instant claims at least because of the broad pH recitation. See MPEP § 716.
According to the analysis above, not only are the results not directly comparative, whatsoever, the results are not unexpected in any way. It is widely known within the art that acidic conditions drastically change the biochemical microenvironment, leading to the unfolding of proteins, and change in trans membranous ion concentrations, which can interfere with biological activity and viability. The pH range of the comparative examples is akin to mildly acidic water. Thus, the pH range of the instantly claimed compositions is significantly lower than that of the comparative composition, which may contribute to the antiviral results, more than any combination of the components of the composition, altogether. Thus the compositions are not at all comparative. Furthermore, MPEP § 716.02 (b) (II) states,
III. DIRECT AND INDIRECT COMPARATIVE TESTS ARE PROBATIVE OF NONOBVIOUSNESS
Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). See In re Blondel, 499 F.2d 1311, 1317, 182 USPQ 294, 298 (CCPA 1974) and In re Fouche, 439 F.2d 1237, 1241-42, 169 USPQ 429, 433 (CCPA 1971) for examples of cases where indirect comparative testing was found sufficient to rebut a prima facie case of obviousness.
The patentability of an intermediate may be established by unexpected properties of an end product “when one of ordinary skill in the art would reasonably ascribe to a claimed intermediate the ‘contributing cause’ for such an unexpectedly superior activity or property.” In re Magerlein, 602 F.2d 366, 373, 202 USPQ 473, 479 (CCPA 1979). “In order to establish that the claimed intermediate is a ‘contributing cause’ of the unexpectedly superior activity or property of an end product, an applicant must identify the cause of the unexpectedly superior activity or property (compared to the prior art) in the end product and establish a nexus for that cause between the intermediate and the end product.” Id. At 479.
For the reasons outlined above, the comparisons set forth in the instant specification are not direct and do not isolate variables. The tested compositions have different pH, different combined components, or and different concentrations of quaternary ammonium compounds. Thus, no trend in the data can be established which correlates to the instant claims. See MPEP § 716.01(d). According to MPEP § 716.02 (e), Applicant may rebut a case of prima facie case of obviousness, by direct comparison with the closest prior art.
An affidavit or declaration under 37 CFR § 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). “A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference.” In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential).
However, as discussed above, there is no such direct comparison demonstrated within the instant specification or direct comparison to the closest prior art. It is important that the evidence relied upon for the analysis is probative (MPEP § 716.01). Thus, Arguments by applicants or their representative will not suffice The prior art comparison chosen by Applicant is not directly comparative to the instantly claimed composition. Applicants have not provided conclusive explanation as to which altered parameter led to these results within the experiments. The examples are neither comparative, nor are the results unexpected in any way.
I. THE CLAIMED INVENTION MAY BE COMPARED WITH PRIOR ART THAT IS CLOSER THAN THAT APPLIED BY THE EXAMINER
Applicants may compare the claimed invention with prior art that is more closely related to the invention than the prior art relied upon by the examiner. In re Holladay, 584 F.2d 384, 199 USPQ 516 (CCPA 1978); Ex parte Humber, 217 USPQ 265 (Bd. App. 1961) (Claims to a 13-chloro substituted compound were rejected as obvious over nonchlorinated analogs of the claimed compound. Evidence showing unexpected results for the claimed compound as compared with the 9-, 12-, and 14- chloro derivatives of the compound rebutted the prima facie case of obviousness because the compounds compared against were closer to the claimed invention than the prior art relied upon.).
With respect to the obviousness rejection in the previous Final rejection, filed 03/11/2025, Stulens appears to be closer prior art than the comparative examples provided within the instant specification at tables 2 and 3. Namely the inclusion of citric acid salt in a buffering capacity, and the common pH range with respect to the instant claims. However, no such comparison with the prior art of record, or with prior art that is closer than that applied by the examiner has been set forth. Furthermore, no additional data has been provided or discussed by Applicant to demonstrate any unexpected results or arguments insufficient to overcome a prima facie case of obviousness. If Applicant presents such comparisons and any unexpected results, the results will be weighed according to MPEP § 716.02 (c)(I).
I. EVIDENCE OF UNEXPECTED AND EXPECTED PROPERTIES MUST BE WEIGHED
Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) The court held the evidence of nonobviousness was not sufficient to rebut the evidence of obviousness.); In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) (Evidence of improved feed efficiency in steers was not sufficient to rebut prima facie case of obviousness based on prior art which specifically taught the use of compound X537A to enhance weight gain in animals because the evidence did not show that a significant aspect of the claimed invention would have been unexpected.) See MPEP § 716.01(d) for guidance on weighing evidence submitted to traverse a rejection.
Thus, the burden is on the applicant to not only demonstrate that any asserted unexpected results are both significant and unexpected, but also that they are directly attributable to the instantly claimed composition and not on a parameter such as pH alteration, which may be considered a routine optimization and therefore, obvious. Most importantly, Applicant must provide a comparison with the closest prior art in order to demonstrate that a result is unexpected. Mere attorney argument or conclusory statements without adequate supporting evidence or insufficient to rebut a prima facie case of obviousness.
Applicants are reminded that “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Furthermore, applicant argues that the results of multiple antiviral and antibacterial activity demonstrated within the instant specification would not be expected by a person of ordinary skill in the art. The applicant further argues that the efficacy of the instantly claimed against both enveloped and non-enveloped viruses is limited because products which have such efficacy typically leave residue and/or stains on household services if used in high amounts in a product. Applicant further argues that there is a need to develop freshening composition for malodor removal, freshening intimate services while providing second benefits of reducing bacteria and/or virus activity on inanimate surfaces or articles without the need of increasing levels of the antimicrobial actives while minimizing residue and/or residue stains on the treated surfaces. Furthermore, the instantly claimed combination of instantly claimed acid with a salt of citric acid buffer is cited as the important factor for said activity. Applicant argues that the added advantage of the pH range of 3 to 6 allows for the instantly claimed composition to perform such functional properties, yielding improved antivirus activity values. Finally, Applicant argues that Stulens does not give one skilled in the art reason to expect these results of efficacy on one enveloped viruses and one non-enveloped viruses disposed on an inanimate surface.
Applicant arguments are found not persuasive because Stulens discloses all these components and a pH range of 3 to 5, which overlaps with the instantly claimed range, as outlined explicitly in the rejection, found in the following section. Therefore, a person of ordinary skill in the art would have arrived at the instantly claimed composition following the teachings of the prior art. Furthermore, since the claimed properties are dependent on pH and the specific mixture of antimicrobial agents and the composition of Stulens in substantially the same amount as instantly claimed, the composition of Stulens necessarily possess the properties claimed.
With respect to the 35 U.S.C. § 103 of claim 6 as being unpatentable over Stulens (see earlier citation), in view of Huetter (U.S. Patent Application Publication No. US 2008/0275113 A1, published 6 Nov 2008), Applicant argues that the deficiencies overcome using the arguments against claim 1, are grounds for overcoming the rejection of claim 6. However, no arguments, data, or additional experiments commensurate with unexpected results have been presented to overcome said case of prima facie obviousness.
Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein.
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. § 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16, 17, and 20 are rejected under 35 U.S.C. 112 § (b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 16 and 21, the terms “antiviral activity value of at least 1” in the claims do not adequately describe a specific test or result administered to determine the activity of the composition, and renders the claim indefinite. The terms “antiviral activity” or “antiviral activity value of at least 1” are not defined by the claim, the specification does not provide a standard for ascertaining the specific test used, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
For example, there are a number of tests used within the state of the art to determine whether or not a composition or material is antiviral. According to the International Organization for Standardization (ISO) offers several tests which can be used to determine the said functional property on porous and nonporous surfaces, such as ISO22196 and ISO18184 (International Organization for Standardization (ISO), Online Browsing Platform (OBP) https://www.iso.org/obp/ui/en/#iso:std:iso:21702:ed-1:v1:en). According to MicroStarLab, (ISO22196, R2020-306-1A, published July 22, 2020), ISO22196 measures efficacy of a composition as the log of reduction (R) which at 90% corresponds to a value of 1 (page 4). According to Ramkumar, (Microbe Investigations Switzerland, ISO 18184 Test Method Explained, published October 12, 2021) a similar 90% reduction value and ISO18184 also corresponds to a value of R equal to 1.
Thus, both ISO22196 and ISO18184 tests may yield antiviral activity results corresponding to an activity value of 1. However, tests are distinct in their interpretation of an activity value of 1. In the case of ISO22196, an activity value of 2 or more is deemed to be effective (MicroStarLab page 4). Thus, the activity value of the instantly claimed value of 1 will be considered an effective according to ISO22196. Similarly, with regard to ISO18184, an activity value of 3 or more is considered excellent performance. An activity value of 1 is considered a failure (Ramkumar page 2). A skilled artisan would not be apprised of the scope of the invention based on the presently recited antiviral value of 1, as a plurality of tests produce a similar measure of reduction value (R), and are interpreted distinctly as such.
Regarding claim 17, the terms “antibacterial activity value of at least 1” in the claims do not adequately describe a specific test or result administered to determine the activity of the composition, and renders the claim indefinite. The terms “antibacterial activity” or “antibacterial activity value of at least 1” are not defined by the claim, the specification does not provide a standard for ascertaining the specific test used, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
For example, there are a number of tests used within the state of the art to determine whether or not a composition or material is antibacterial. According to the International Organization for Standardization (ISO) offers several tests which can be used to determine the said functional property on porous and nonporous surfaces, such as ISO22196 and ISO20743 (International Organization for Standardization (ISO), Online Browsing Platform (OBP) https://www.iso.org/obp/ui/en/#iso:std:iso:21702:ed-1:v1:en). As discussed earlier, MicroStarLab teaches wherein ISO22196 measures efficacy of a composition as the log of reduction (R) which at 90% corresponds to a value of 1. Similarly, according to Microbe Investigations Switzerland, hereinafter MIS, ISO20743 is measured as a log of reduction (R), which may also have an activity value corresponding to 1 (Microbe Investigations Switzerland, ISO 20742:2013).
Thus, both ISO22196 and ISO20743 tests may yield antibacterial activity results corresponding to an activity value of 1. However, tests are distinct in their interpretation of an activity value of 1. As discussed earlier, in the case of ISO22196, an activity value of 2 or more is deemed to be effective (MicroStarLab page 4). Thus, the activity value of the instantly claimed value of 1 will be considered ineffective according all to ISO22196 tests. Similarly, with regard to ISO20743, an activity value of 2 or more is considered a passing performance (MIS, page 4-), and as such, an activity value of 1 is considered a failure. A skilled artisan would not be apprised of the scope of the invention based on the presently recited antibacterial activity value of 1, as a plurality of tests produce a similar measure of reduction value (R), and are interpreted distinctly as such.
Therefore, claims 16, 17, and 20 are deemed indefinite for failing to particularly point out the specific the requisite test for which the composition which displays antiviral/antibacterial activities.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-5 and 7-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Stulens (U.S. Patent Application Publication No. 2002/0175092A1, published 28 November 2002).
Regarding claim 1, Stulens discloses a liquid cleaning composition for cleaning floors and other large surfaces (paragraph [0002]) wherein the ingredients in the composition are selected so as to avoid the appearance of spots/films on the treated surface, even when the surface is not rinsed (paragraph [0100]). The composition may comprise from about 99% to about 80% of deionized or softened water (paragraph [0186]). For purposes of soap scum and hard water stain removal, the composition can be made acidic with a pH of from about 2 to about 5 (paragraph [0052]). Acidity is accomplished through the use of one or more organic acids (paragraph [0052]). Suitable organic acids include polycarboxylic acids (paragraph [0052]). The amount of organic acid in the composition can be from about 0.01% to about 1% (paragraph [0053]). The composition may also comprise a buffer such as sodium citrate (i.e., salt of citric acid) (paragraph [0083]). The buffer may be present from about 0.005% to about 0.05% (paragraph [0083]). Further, Stulens teaches wherein the composition comprises preservatives such as dioctyl dimethyl ammonium chloride (i.e., claimed first antimicrobial agent) and didecyldimethyl ammonium chloride (i.e., claimed second antimicrobial agent). The preservatives are present at concentrations of from about 0.0001% to about 0.01%. (paragraph [0085]). The composition may be in neat form (paragraph [0004]).
Stulens discloses a no-rinse (paragraph [0100]) composition containing from about 99% to about 80% water (paragraph [0186]), a polycarboxylic acid (paragraph [0053]), sodium citrate (i.e., salt of citric acid) (paragraph [0083]), dioctyl dimethyl ammonium chloride (i.e., claimed first antimicrobial agent), and didecyldimethyl ammonium chloride (i.e., claimed second antimicrobial agent) (paragraph [0085]). Further, Stulens discloses preservatives such as quaternary ammonium salts including dioctyl dimethyl ammonium chloride and didecyl dimethyl ammonium chloride used as antimicrobial agents; stating they can provide antibacterial control on the surfaces, but typically will require use at higher levels from about 0.005 to about 0.1% (paragraph [0085]).
Stulens does not disclose the instantly claimed features with sufficient specificity for anticipation. Rather the instantly claimed elements must be selected from various parts of Stulens. Nonetheless, it would have been prima facie obvious to a person having ordinary skill in the art following the teachings of Stulens to make the instantly claimed combination since all the instantly claimed elements were known in the prior art, one skilled in the art would have been motivated to combine the elements based on their respective prior art recognized functions, and the combination yielding nothing more than a person having ordinary skill in the art would have predicted. See MPEP 2143(I)(A).
Although Stulens teaches a lower concentration of quaternary ammonium compounds of skill in the art would have been motivated to increase the amount of first and second antimicrobial, in order to increase the antimicrobial effectiveness of the resulting composition. MPEP 2144.05(II). Firstly, the instant claims do not require the presence of polymers, whose properties should be preserved. Instant claim 12 lists polymers as one of four choices of malodor counteractant agents. In the case that the malodor counteractant is an aldehyde, chosen from the options in claim 12, the teaching of a quaternary ammonium surfactant at less than 0.05% to preserve the benefits of polymers in the composition does not apply. With respect to desirable alternatives suggested in the prior art, the courts have stated:
“The disclosure of desirable alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. In In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004), the claims of a utility patent application were directed to a shoe sole with increased traction having hexagonal projections in a "facing orientation." 391 F.3d at 1196-97, 73 USPQ2d at 1142. The Board combined a design patent having hexagonal projections in a facing orientation with a utility patent having other limitations of the independent claim. 391 F.3d at 1199, 73 USPQ2d at 1144. Applicant argued that the combination was improper because (1) the prior art did not suggest having the hexagonal projections in a facing (as opposed to a "pointing") orientation was the "most desirable" configuration for the projections, and (2) the prior art "taught away" by showing desirability of the "pointing orientation." 391 F.3d at 1200-01, 73 USPQ2d at 1145-46. The court stated that "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." Id. In affirming the Board’s obviousness rejection, the court held that the prior art as a whole suggested the desirability of the combination of shoe sole limitations claimed, thus providing a motivation to combine, which need not be supported by a finding that the prior art suggested that the combination claimed by the applicant was the preferred, or most desirable combination over the other alternatives. Id. See also In re Urbanski, 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed. Cir. 2016) (see MPEP 2143.01 (I)).
Thus, the suggestion in the prior art, that quaternary ammonium compounds be used at concentrations no higher than 0.05% of the composition, so as to preserve the integrity of polymers when applied to hard surfaces, is not considered “a teaching away.” It is specifically noted that Stulens teaches the limitation of the low concentration of quaternary ammonium compounds specifically applies to the use of the composition on hard surfaces (paragraph [0085]) in the presence of combinations that include polymers. However, the instant claims contain no mention of any polymer, which would be the only reason to limit the concentration of quaternary ammonium compounds. Furthermore, an ordinary skilled artisan would not exclude a higher concentration of quaternary ammonium compounds for uses other than the treatment of hard surfaces. Still, an ordinary artisan would have rationale to increase the quaternary ammonium compound, in order to increase the antimicrobial activity of the composition. Before the filing of the present application, a person having ordinary skill in the art would have been directly motivated to modify the concentration of quaternary ammonium compounds, so as to increase the antimicrobial property of the composition.
Furthermore, the alteration of a certain concentration does not support the patentability of subject matter, as it is considered a routine optimization or within prior art conditions. According to MPEP 2144.05 (II) A,
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.).
According to the instant specification, Table 4, the instantly claimed concentrations of the quaternary ammonium compounds have not been demonstrated to be critical, as their alteration within the instantly claimed embodiments and comparative embodiments perform differently at different pH values. That is, at the same quaternary ammonium compound concentrations, but different pHs, the behavior of said composition is different. This means that the critical component is the pH and not the quaternary ammonium compound concentration. Therefore, merely changing the instantly claimed concentrations of quaternary ammonium compounds as first and second antimicrobial agents in order to distance the instantly claimed from the prior art does not support patentability, as this range is not critical to the antimicrobial properties of instantly claimed composition.
Regarding the recitation of a mixture of first and second antimicrobial agent in instant claim 1, Stulens does not disclose wherein preservatives dioctyl dimethyl ammonium chloride (i.e., claimed first antimicrobial agent) and didecyldimethyl ammonium chloride (i.e., claimed second antimicrobial agent) are in a mixture. However, since Stulens discloses the use of various preservatives individually, the use of the individual species in combination would have been obvious since it is prima facie obvious where each preservative was taught by Stulens to be useful for the same purpose. The idea for combining them flows logically from having been individually taught in the prior art. See MPEP 2144.06.
Regarding claim 1 reciting a weight ratio of the total amount of the carboxylic acid and the salt of citric acid to the mixture of the first and second antimicrobial agent is from 1:1 to 10:1. As discussed above, Stulens teaches the amount of organic acid in the composition can be from about 0.01% to about 1%, the amount of sodium citrate is from about 0.001% to about 0.05% and the amount of preservatives (i.e., claimed antimicrobial agent) is from 0.0001 to about 0.01%. The claimed ratio of carboxylic acid and salt of citric acid to the first and second antimicrobial agents would have been obvious, because selecting an amount of carboxylic acid, sodium citrate, and preservatives from these ranges would lead to a ratio of carboxylic acid and sodium citrate to preservatives that overlaps with the claimed ratio. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP § 2144.05 (I).
Regarding claim 2, the composition taught by Stulens may have pH of from about 2 to about 5, more preferably about 3 (paragraph [0052]), and that the composition may be in neat form (paragraph [0004]).
Regarding claim 3, as discussed above, the composition may comprise a polycarboxylic acid.
Regarding claim 4, as discussed above, the amount of organic acid (e.g., polycarboxylic acid) may be from about 0.01 % to about 1% by weight of the composition.
Regarding claim 5, as previously stated with regards to claim 1, the composition may include sodium citrate.
Regarding claims 7, 8, and 9, as discussed above, the composition may comprise dioctyl dimethyl ammonium chloride and didecyl dimethyl ammonium chloride.
Regarding claims 10 and 11, as discussed above, the preservatives (i.e., claimed antimicrobial agents) are present at concentrations of from about 0.0001% to about 0.01%.
Regarding claim 12, the composition may further comprise perfume components such as aldehydes (paragraph [0075]).
Regarding claims 13 and 14 reciting wherein the composition is for treating a permeable soft surface, this is merely a recitation of the intended use of the composition. If the prior art structure is capable of performing the intended use, then it meets the claim. Stulens discloses wherein the composition may be used on walls (paragraph 0086]). Accordingly, the composition of Stulens would be useable on a permeable soft surface such as drywall since it may be applied to walls and drywall is a type of wall.
Regarding claims 13 and 15, Stulens teaches wherein the composition may be applied to wood floors (paragraph [0188]).
Regarding claims 16, 17, and 20, in reciting wherein the composition comprises an antivirus activity value of at least 1 and an antibacterial activity of at least 1, page 4, lines 2-9 of the instant specification discloses wherein providing a pH of from 3 to 6 at room temperature for a mixture of antimicrobial agents provides a low pH environment with higher concentration of protons to boost the performance of the mixture of antimicrobial agents to provide freshness and multiple secondary benefits of antivirus efficacy to reduce activity of specific enveloped and non-enveloped viruses and antibacterial efficacy to reduce activity of specific bacterium species. As a result, the levels of antimicrobial agents can be formulated at low levels to provide the antivirus and antibacterial efficacy without impacting a freshening product’s scent profile. Accordingly, since the claimed properties are dependent on pH and specific mixture of antimicrobial agents and the composition of Stulens has a pH of from about 2 to about 5 and comprises substantially the same antimicrobial agents as claimed (i.e., dioctyl dimethyl ammonium chloride and didecyldimethyl ammonium chloride) in substantially the same amount as claimed (i.e., about 0.0001% to about 0.01%), the composition of Stulens necessarily possess the properties claimed in claims 16, 17, and 20.
Further regarding claims 16, 17, and 20, the claims are all dependent on claim 1, which claims the composition at a pH range of 3-6. However, the instant specification, tables 3 and 4 detail that only a single embodiment (at a pH of 5) is capable of efficacy against both enveloped and non-enveloped viruses as well as a range of bacterial species. The claims e data provided in the specification does not support the entirety of the claimed pH range because the data demonstrates proof of concept only at pH XYZ rather than across the claimed range. Thus, the specification is insufficient with respect to description of a representative number of species commensurate with the scope claimed. According to MPEP 2163 (II) A 3 (a) ii,
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Therefore, the Applicant’s demonstration of only a single species as having antimicrobial efficacy demonstrates that the property of the instantly claimed composition is not commensurate with the scope claimed.
Regarding claim 18, Stulens teaches wherein the cleaning composition may be delivered in the form of a pre-moistened mop (i.e., wipe) (paragraph [0189]).
Regarding claim 19, Stulens further disclose wherein it is beneficial to incorporate antimicrobials (paragraph [0158]). The antimicrobial actives are chosen to be effective against gram-positive and gram-negative bacteria and enveloped and non-enveloped viruses (paragraph [0165]). The composition has residual disinfectancy in that it is cidal against bacteria and other microorganism for a period of about 8 to about 72 hours (paragraph [0164]).
Claim 6 is rejected under of 35 § U.S.C. 103 as being unpatentable over Stulens (U.S. Patent Application Publication No. 2002/0175092A1, published 28 November 2002) in view of Huetter (U.S. Patent Application Publication No. US 2008/0275113 A1, published 6 Nov 2008).
Regarding claim 6, the teachings of Stulens are discussed above. Stulens does not disclose wherein the amount of sodium citrate is from about 0.25% to 5%.
Huetter teaches an antimicrobial composition (abstract). The antimicrobial composition may be used to sanitize and/or cleanse a surface prior to exposure to one or more bacterial and/or virus-related diseases (paragraph [0024]). The composition comprises at least one acid. The acid facilitates the creation of a low pH buffer on the surface of a substrate and prolong the residual antimicrobial activity (paragraph [0057]). The composition comprises at least one acid at concentrations from about 0.01% to about 15% (paragraph [0058]). Suitable acids include citric acid and salts thereof (paragraph [0059]). The composition has a pH of from about 1 to about 7 (claim 11).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its prior art recognized suitability for the particular use. See MPEP 2144.07. Stulens discloses wherein the composition has a pH of from about 2 to about 5 and comprises sodium citrate as a buffer. Accordingly, it would have been obvious to one of ordinary skill in the art to used sodium citrate at a concentration from about 0.01% to about 15% since this is another known and effective amount of buffer for a cleaning composition as taught by Huetter. One of ordinary skill in the art would have had a reasonable expectation of success since about 0.01% to about 15% of a citric acid salt is an effective amount for a composition with a pH from about 1 to about 7 as taught by Huetter and the pH of the composition of Stulens is from about 2 to about 5.
Finally, claims 1-18 are claims to a composition. The intended use of said composition for the cleaning of a hard surface does not affect the composition itself. For instance, a decrease in the operation of polymers would not affect the many uses of the composition outside of those of hard surface. Specifically, the use of the composition on soft surfaces, as detailed in claim 13, would not require that quaternary ammonium compounds be used at concentrations no higher than 0.05% of the composition. Regardless, all of the teachings of the instantly claimed composition are taught in the prior art by Stulens.
Correspondence
No claim is allowed.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623