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 .
Detailed Action
Previous Rejections
Applicants' arguments, filed 12/03/25, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-4, 7-8, 10-12, 15, 23, 26, 29 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Naqvi et al. (WO 2020/214916 A1) in view of (Anonymous: "Specification Sheet NeoDefend Characteristic Specification Appearance Off White Powder Glucono Delta Lactone", 18 February 2022 (2022-02-18), pages 1-1, presented in IDS), and (Anonymous: "NeoDefend | Lotioncrafter", 20 September 2020 (2020-09-20), pages 1-4, presented in IDS) and Moore et al. (USP 8,877,240).
Naqvi teaches use of NeoDefend, gluconolactone and sodium benzoate as preservative in 30-35%, see example 1. Naqvi teaches use of citric acid, sodium carbonate, polyethylene glycol 8000 and surfactant in example 1, [0059]. In Example 2, Naqvi teaches in tablets-Effervescent ingredients 45/55%, preservatives 30-40% and 10-20% surfactant in Example 2, see [0060]. Naqvi et al. teaches in example 8 an effervescent cleanser tablet with 10-16 wt % NeoDefend, see (paragraph [0005] - paragraph [0007]; paragraph [0009]; paragraph [0039]; paragraph [0045]; paragraph [0069]; paragraph [0088]; paragraph [0091]; paragraph [0096] - paragraph [0097]; paragraph [0101] - paragraph [0102]; paragraph [0104]; paragraph [0115]; paragraph [0229]; paragraph [0236] - paragraph [0237]; paragraph [0289] - paragraph [0293]) and claims. Completed tablets in packaging, such as compostable pouches, see description. The tablet of example 8 therefore contains 7-13 wt % GDL, 2.2-4.48 % SB, 34-40 wt% citric acid, (effervescence generator), 11-19 wt% sodium carbonate/sodium bicarbonate as base, a non-ionic surfactant (ethoxylated alcohol), chelating agent, binder, silicon dioxide carrier, lubricant, fragrance and dye. Examples 7 and 11 also disclose effervescent cleanser tablets with 10-30 wt% SB and 0-12 or 0-10 wt% GDL, and both of said ranges overlap with the claimed ranges. Furthermore, example 1 discloses an effervescent cleanser composition comprising 30-35 wt % NeoDefend, hence 21-28% GDL and 6.6-9.8% SB and example 3 discloses similar compositions with respectively 15-25 wt% SB and 0-6 wt% GLD or 14-24 wt% GDL and 4.4-8.4 wt% SB. According to paragraph 45 an MCT oil may create a hydrophobic layer on the exterior of the powder within the tablet press, such a layer is considered to be a protective layer. The tablets may be used to form hand soaps. Naqvi teaches use of humectant-Polyethylene Glycol 8000 and Neodefend-Gluconolactone and sodium benzoate, citric acid, sodium carbonate and sodium bicarbonate in example 8, [0067]. The tablet of embodiment 19 comprises emollient. Triglycerides as oil and process aid, see [0070]. Emollient, preservative sodium benzoate, sodium alginate as emollient, potassium sorbate as preservative, see example 13, [0072].
Naqvi does not provide breakdown of NeoDefend as used in the example discussed above.
According to the anonymous references it is shown on (page 1) that NeoDefend contains 70-80 wt% glucono delta lactone (GLD), (a sugar acid lactone), and 22-28 wt % sodium benzoate (SB) (a preservative). The anonymous document was publicly available before the priority date of the present application (see page 1).
It is explicitly disclosed in Naqvi that NeoDefend is added as a preservative. Since the compositions of Naqvi contain the claimed preservative combination in the claimed amounts it is inherent that the cleaning methods disclosed in Naqvi also result in a method of disinfecting in the course of carrying out what has been made available to the public in Naqvi. The method of disinfecting, insofar as sufficiently disclosed, therefore does not involve a new use of the known preservatives and compositions comprising them. Naqvi discloses that a spray bottle is filled with about 0.5-1 L water and that one or two of the effervescent tablets are dissolved in water to form a solution with a pH of 4-5 or 6. The instant claim recites that about 0.05-50 wt% of the solid composition is dissolved in the solvent, whereas Naqvi does not disclose the weight of the tablet. The effect of the difference is that these amounts of composition and solvent determine the amount of preservative in the solution. It would be an obvious matter for the skilled person to calculate the amount of composition that needs to be dissolved in order to arrive at the desired amounts of sugar acid lactone and preservative in the solution for preservative properties.
Naqvi does not teach the exact amount of sugar acid lactone and preservative. However, Naqvi teaches the generic amount of Neodefend components in an effervescent tablet, such as example 1, [0059] discloses an effervescent cleanser composition comprising 30-35 wt % NeoDefend, hence 21-28% GDL and 6.6-9.8% SB and example 3 discloses similar compositions with respectively 15-25 wt% SB and 0-6 wt% GLD or 14-24 wt% GDL and 4.4-8.4 wt% SB. Example 4 discloses Neodefend 25-30%, [0063]. Therefore, it would be obvious to one of ordinary skill to have optimized the amount of preservative and sugar acid lactone for disinfection purposes by performing experimental manipulations.
While the reference in example 8 teaches use of a binder, the references discussed above do not teach use of tablet binder such as sodium acetate, calcium acetate or magnesium acetate as claimed.
Moore teaches use of binders such as sodium acetate, calcium acetate or magnesium acetate in a disinfecting and cleaning tablet compositions/formulations, see claims 1-4 and 12. Moore teaches that the tablet binding compositions provided herein can produce tablets of increased hardness at lower compression forces and, when dissolved, yield solutions of increased clarity compared to some traditional binder compounds, see abstract. Moore further teaches that an object of the invention is to provide a tablet binding composition that reduces the number of components needed in the production of readily dissolvable tablets. Another object of the present invention is to provide a tablet binding composition that binds components of a cleaning composition during compression and releases the tablet from the press mold without breaking, sticking or picking, see column 2, second paragraph. The amount of acetate taught ranges from 15% to about 85%, see claim 14 and this amount overlaps with the claimed amount and thus creates a case of obviousness because in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
It would have been obvious to one of ordinary skill to have utilized the known binders for making tablet or compressing tablets used for disinfecting purposes into the formulation and composition of Naqvi et al. as Naqvi teaches use of binders in claim 1 and Moore teaches that the tablet binding compositions provided herein can produce tablets of increased hardness at lower compression forces and, when dissolved, yield solutions of increased clarity compared to some traditional binder compounds, see abstract. Moore further teaches that an object of the invention is to provide a tablet binding composition that reduces the number of components needed in the production of readily dissolvable tablets. Therefore, utilization of known ingredients in tablet formulation would have provided predictable results of making a tablet binding compositions. Additionally, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Claims 12, 15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Naqvi et al. (WO 2020/214916 A1) in view of (Anonymous: "Specification Sheet NeoDefend Characteristic Specification Appearance Off White Powder Glucono Delta Lactone", 18 February 2022 (2022-02-18), pages 1-1, presented in IDS), (Anonymous: "NeoDefend | Lotioncrafter", 20 September 2020 (2020-09-20), pages 1-4, presented in IDS), and Moore et al. (USP 8,877,240) and further in view of Stadler et al. (WO 2012/167920A1).
The references discussed above do not teach use of specific humectants, emollients and foam booster in the composition.
Stadler et al. disclose us of glycolipids for avoiding microbial contamination of materials, see title and abstract. Stadler teaches certain emollient solvents exhibit synergistic action when combined with essential oils or ingredients against microorganisms as noted in WO 03/034997, which is incorporated by reference in its entirety and the emollients are used as preservatives, see page 5, second paragraph. The tablets include effervescent mixtures, foam boosters, humectants, emollients, see page 68, first paragraph. Examples 27 and 28 disclose medical sanitizing/disinfecting compositions. Use of glycerin, stearyl alcohol, mineral oil and glyceryl isostearate is disclosed in examples. (Thus, the reference teaches use of the known humectants, emollients and foam boosters and effervescent used in the solid dosage forms which provide decontaminating and sanitizing effects). The use is taught for toilet water, a cleansing product, toilet soap, medical device and active packaging material etc., see page 67, fifth paragraph and page 66, 2nd paragraph.
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have utilized the humectant, emollient and foam booster in the effervescent solid dosage form of Naqvi et al. used for decontamination purposes. One of ordinary skill would have been motivated to do so because Naqvi teaches effervescent cleanser tablet with 10-16 wt % NeoDefend, comprising 70-80 wt% glucono delta lactone (GLD), (a sugar acid lactone), and 22-28 wt % sodium benzoate (SB) (a preservative) used in hand soaps etc. and Stadler teaches a solid composition which can include humectant, emollient (acting as preservatives) and foam boosters used in a composition for microbicidal effect which can be in the form of a toilet soap, or a cleansing product as discussed above. Thus, utilization of known components would have provided predictable results of making a composition in a solid dosage effervescent from used for microbicidal effects.
Applicant argues that Moore only includes acetate salts to help bind the C6 saccharide derivative sequestrants to achieve similar or superior results to that of boric acid. Moore, col.7, line 54- col. 8, line 13. Thus, Moore's teaching of acetate salts is due to the use of a C6 saccharide derivative in the tablet formulation. There is no teaching that an acetate salt would be an effective or useful binder in other formulations. Further, Naqvi teaches binders that include polyethylene glycol and sorbitol. Naqvi, Examples. There is no teaching, suggestion, or motivation for a person skilled in the art to replace the taught binders of Naqvi with an acetate that may not provide the same results as those in Moore, as the Examiner is suggesting. Thus, as there is no objective reason to modify and that there is no suggestion to modify the binders to replace with acetate, there is no prima facie case of obviousness.
Applicant’s arguments are fully considered but is not persuasive. As discussed in the rejections above, since Naqvi suggests use of binders in claim 1, it would have been obvious to one of ordinary skill to have utilized the known binder because Moore teaches that the tablet binding compositions provided herein can produce tablets of increased hardness at lower compression forces and, when dissolved, yield solutions of increased clarity compared to some traditional binder compounds, see abstract. Moore further teaches that an object of the invention is to provide a tablet binding composition that reduces the number of components needed in the production of readily dissolvable tablets. Another object of the present invention is to provide a tablet binding composition that binds components of a cleaning composition during compression and releases the tablet from the press mold without breaking, sticking or picking, see column 2, second paragraph. Therefore, Moore’s teaching of the acetate as binders was known in the art and one of ordinary skill would have utilized the known binder for its intended use. In regard to applicant’s arguments that Moore's teaching of acetate salts is due to the use of a C6 saccharide derivative in the tablet formulation is also not persuasive because the open-ended comprising language of the instant claims do not preclude reading any other limitation into the claim and additionally, it is due to the property of tableting and binding advantages of using the acetate binder that has been used in the rejections which is taught by Moore et al. whose use has been known in the art. It is held that it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07.
Action is final
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.
Correspondence
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/SNIGDHA MAEWALL/Primary Examiner, Art Unit 1612
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