DETAILED ACTION
All rejections and objections not mentioned below have been withdrawn.
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 .
Claim Rejections - 35 USC § 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 13-16 and 19 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.
The term “useful” in claims 13-16 and 19 is a relative term which renders the claim indefinite. The term “useful” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification provides no definition for ascertaining what would be considered a useful plant but instead only gives examples on page 11. One of ordinary skill in the art would not know what might be considered useful under the scope of this claim because for example many plants may be useful to one person and not another. Trees for example are useful for timber but useless to farmers. Grass might be useful to sports fields but considered a weed in a garden. Dandelions are often considered weeds but are edible plants.
Claim Rejections - 35 USC § 103 -Updated Due to Amendments
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claim(s) 1, 11, 12, 13, 14, 15, 16, 17, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over HONE (HONE et al., WO 2019158476 A1, 2019-08-22, IDS) in view of FABRI (FABRI et al., WO2018198009A1, 2018-11-01, IDS).
The reference HONE teaches “WO2013/14381 1 discloses methods for preparing the compound cis-N-[2-(2,4- dichlorophenyl)cyclobutyl]-2-(trifluoromethyl)pyridine-3-carboxamide which is a racemate of the two enantiomers N-[(1 S,2S)-2-(2,4-dichlorophenyl)cyclobutyl]-2-(trifluoromethyl)pyridine-3-carboxamide and N-[(1 R,2R)-2-(2,4-dichlorophenyl)cyclobutyl]-2-(trifluoromethyl)pyridine-3-carboxamide. Cis-N-[2-(2,4- dichlorophenyl)cyclobutyl]-2-(trifluoromethyl)pyridine-3-carboxamide is exemplified in Table 57, example 57.01” (page 1), The reference also teaches “The invention relates to crystalline forms of N-[2-(2,4-dichlorophenyl)cyclobutyl]-2- (trifluoromethyl)pyridine-3-carboxamide of formula (I), compositions comprising said crystalline forms and methods of their use as nematicides or fungicides.”(abstract) and “Agrochemical compositions comprising cis-N-[2-(2,4-dichlorophenyl)cyclobutyl]-2- (trifluoromethyl)pyridine-3-carboxamide or its enantiomer N-[(1 S,2S)-2-(2,4-dichlorophenyl)cyclobutyl]- 2-(trifluoromethyl)pyridine-3-carboxamide have generically been disclosed in both WO2013/14381 1 and WO2015/003951. However, the application of certain types of formulations is dependent on the particular form, i.e. polymorphic or amorphous form, used to prepare the formulation. For example, if the form used to prepare a suspension concentrate (SC) is not stable in such a SC formulation, polymorphic conversion might occur in the formulation leading to unwanted crystal growth. Such crystal growth may be detrimental because it may lead to thickening and potentially solidification of the formulation which can in turn lead to blockages in application equipment, e.g. in spray nozzles in agricultural application machinery. Hence, there is a need to provide stable crystalline forms of the above compound to prepare agricultural or pharmaceutical formulations thereof”(page 1). Which is the same compound as instant component A as shown below (abstract).
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The reference also teaches “As mentioned previously, it is crucial for the successful application of an agrochemical and/or pharmaceutical formulation that the crystalline form is stable in the particular formulation environment. Flowable concentrates for seed treatment (FS) formulations were prepared for both Form A and Form B. The only difference between the two formulations was the polymorphic form used, all of the other components were identical. The formulations were tested for the crucial stability according to a temperature cycling test which is shown in Figure 12. The formulations were analyzed under a microscope (40x) for possible crystal growth which can have detrimental consequences such as thickening and potentially solidification of the formulation which can in turn lead to blockages in application equipment, e.g. in seed coating equipment or in spray nozzles in agricultural application machinery. Pictures were taken of the formulations at (i) start (Figures 13a and 14a), (ii) immediately after the temperature cycling test (Figures 13b and 14b) and (iii) two days at room temperature (RT) after the temperature cycling test (Figures 13c and 14c). The pictures are shown for the formulation comprising Form A in Figures 13a, 13b and 13c and the pictures for the formulations comprising Form B in Figures 14a, 14b and 14c. One can see in Figures 13a and 14a that both formulations did not exhibit any crystal growth before the temperature cycling test. Figure 13b exhibited clear crystal growth after the temperature cycling test. Storing the formulation for another two days at RT led to even further crystal growth (Figure 13c). Surprisingly and unexpected, the same temperature cycling test showed for the formulation comprising Form B no such crystal growth, see Figures 14b and 14c. This is unexpected as both polymorphic forms were shown to be chemically stable in the formulations tested, i.e. no compound degradation was observed. However, Form B was found to be surprisingly resistant to crystal growth when exposed to typical storage conditions. Hence, agrochemical or pharmaceutical compositions comprising the crystalline Form B are preferred.
The agrochemical compositions comprising the polymorphic Form B or C have a very advantageous spectrum of activities for protecting animals and useful plants against attack and damage by nematodes, in particular protecting useful plants against attack and damage by nematodes.
The agrochemical compositions comprising the polymorphic Form B or C have a very advantageous spectrum of activities for protecting animals and useful plants against attack and damage by fungi, in particular protecting useful plants against attack and damage by fungi.
The agrochemical compositions comprising the polymorphic Form B or C may be used for controlling or destroying pests which occur in particular on plants, especially on useful plants and ornamentals in agriculture, in horticulture and in forests, or on organs, such as fruits, flowers, foliage, stalks, tubers, seeds or roots, of such plants, and in some cases even plant organs which are formed at a later point in time remain protected against these pests. The agrochemical compositions of the invention are preventively and/or curatively valuable active ingredients in the field of pest control, even at low rates of application, which can be used against pesticide resistant pests such as insects and fungi, and have a very favorable biocidal spectrum and are well tolerated by warm-blooded species, fish and plants”(pages 4-5) and “1.1 Form A Methods for preparing Form A have been disclosed in WO2015/003951 (Example P5). An example for preparing Form A is as follows… to isolate N-[(1 S,2S)-2-(2,4-dichlorophenyl)cyclobutyl]-2- (trifluoromethyl) pyridine-3-carboxamide (141.6 g)…
1.2 Form B
Form A was dissolved in 10% water/methanol in a HPLC vial. The solvent was allowed to evaporate at room temperature.
…
1.3 Form C
cis-N-[2-(2,4-dichlorophenyl)cyclobutyl]-2-(trifluoromethyl)pyridine-3-carboxamide racemate
…“(page 21-22).
The reference HONE teaches “Normally, in the management of a crop a grower would use one or more other agronomic chemicals in addition to the crystalline polymorph of the present invention. Examples of agronomic chemicals include pesticides, such as acaricides, bactericides, fungicides, herbicides, insecticides, nematicides, as well as plant nutrients and plant fertilizers.
Accordingly, the present invention provides for the use of a composition according to the present invention together with one or more pesticides, plant nutrients or plant fertilizers. The combination may also encompass specific plant traits incorporated into the plant using any means, for example conventional breeding or genetic modification.
The mixtures of the polymorph Form B or C with other active substances may also have further surprising advantages which can also be described, in a wider sense, as synergistic activity. For example, better tolerance by plants, reduced phytotoxicity, insects can be controlled in their different development stages, or better behaviour relating to production, for example grinding or mixing, storage or use.”(page 13-14) and “Preferred mixtures are indicated below where the polymorph Form B or C is indicated as Ί”: Compositions comprising an adjuvant include I + compounds selected from the group of substances consisting of petroleum oils”(page 14). This helps to teach claims 1, 11, 14, 17.
The reference HONE teaches “The polymorphs of the invention may be applied in unchanged form but is more preferably incorporated into agrochemical or pharmaceutical compositions, in particular agrochemical compositions, by conventional means. Accordingly, in a third aspect, there is provided an agrochemical or pharmaceutical composition comprising the crystalline form according to the first aspect (Form B) or any of the embodiments of the first aspect and at least one acceptable, agrochemically and/or pharmaceutically, carrier or diluent. In a fourth aspect, there is provided an agrochemical or pharmaceutical composition comprising the crystalline form according to the second aspect (Form C) or any of the embodiments of the second aspect and at least one acceptable, agrochemically and/or pharmaceutically, carrier or diluent”(page 4). This helps to teach claim 12.
The reference also teaches “ Accordingly, in a fifth aspect, there is provided a method of protecting crops of useful plants against damages caused by nematodes or fungi, which comprises treating the plants or the locus thereof with a composition according to the third or fourth aspects or any embodiments of the third or fourth aspects, in particular treating the plants or the locus thereof with a composition according to the third aspect or any embodiments of the third aspect.
In a sixth aspect, there is provided a method of protecting plant propagation material against damages caused by nematode or fungi, which comprises treating the plant propagation material with a composition according to the third or fourth aspects or any embodiments of the third or fourth aspects, in particular treating the plant propagation material with a composition according to the third aspect or any embodiments of the third aspect”(pages 7-8). This helps to teach claim 13.
The reference HONE teaches “Suitable target plants are for the compositions of the invention, in particular, cereals, such as wheat, barley, rye, oats, rice…”(page 8). This helps to teach claims 15 and 20-21.
The reference HONE does not teach Phenamacril (all claims).
The reference FABRI teaches “Phenamacril has the chemical name ethyl (2EZ)-3-amino-2-cyano-3- phenylacrylate. It is a cyanoacrylate fungicide, which is known to control certain fungi such as fusarium. Benzamacril has the chemical name (EZ)-3- [benzyl(methyl)amino]-2-cyanoacrylic acid, which is another cyanoacrylate fungicide. Monogenic resistance to a new fungicide, JS399-19, in Gibberella zeae (Chen et.al. Plant Pathology (2009) 58, 565-570) teaches discovery of five new Phenamacril resistant isolates for fusarium head blight. There is therefore, a need for resistance management that will allow increased control and decreased resistance.
It has been found that the addition of a cyanoacrylate fungicide such as phenamacril or benzamacril or a combination thereof to benzovindiflupyr leads to a synergistic action with broad spectrum control. It was surprising that the addition of a benzovindiflupyr to the cyanoacrylate fungicides resulted in an enhancement of the efficacy, and a surprising reduction in fungal disease incidence, seen only when these actives are combined. As will be demonstrated in the examples, the synergistic effect of the present combination is far superior to the combinations of the prior art.
These surprising advantages of the combinations of the invention were not observed when the either benzovindiflupyr or either of the cyanoacrylate fungicides were not present in the combination, or when benzovindiflupyr was replaced by similar compounds. Therefore, these unexpected advantages of the combination of the present invention could be attributed to synergism between the two active compounds or class of compounds of the present invention.
Thus, in an aspect, the present invention provides a fungicidal combination comprising:
(a) benzovindiflupyr; and
(b) phenamacril or benzamacril or a combination thereof.
The combination of the present invention may be used to control a broad spectrum of plant diseases, such as: Disease in rice: Blast (Magnaporthe grisea), Helminthosporium leaf spot (Cochliobolus miyabeanus), sheath blight (Rhizoctonia solani), and bakanae disease (Gibberella fujikuroi).
Diseases in wheat: powdery mildew (Erysiphe graminis), Fusariuin head blight (Fusarium graminearum, F. avenacerum, F. culmorum, Microdochium nivale), rust (Puccinia striiformis, P. graminis, P. recondita), pink snow mold (Micronectriella nivale), Typhula snow blight (Typhula sp . ), loose smut (Ustilago tritici), bunt (Tilletia caries), eyespot (Pseudocercosporella herpotrichoides), leaf blotch (Mycosphaerella graminicola), glume blotch (Stagonospora nodorum), septoria, and yellow spot (Pyrenophora tritici-repentis) ” (page 4-5) and “In an aspect, the present invention may provide a combination comprising: (a) benzovindiflupyr;
(b) phenamacril or benzamacril or a combination thereof; and
(c) at least another agrochemical. In an embodiment, said at least another agrochemical may be selected from a fungicide, insecticide, herbicide, biocide, plant growth regulator, plant activator, fertilizers and the like.
In an embodiment, said at least another agrochemical is a fungicide”(page 11-12). This helps to teach claims 1, 16 and 19.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified HONE with FABRI because both disclose fungicidal compositions for the same purpose of protecting useful plants from fungi. It thus would have been obvious to combine the cyclobutrifluram compositions of HONE with the Phenamacril compositions of FABRI to form a third composition for the very same purpose of protecting useful plants from fungi. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One would have a reasonable expectation of success because both compounds are suggested for combination with additional anti-fungi compounds. One would be motivated to do so because HONE teaches mixtures of the polymorph Form B or C with other active substances may also have further surprising advantages which can also be described, in a wider sense, as synergistic activity. For example, better tolerance by plants, reduced phytotoxicity, insects can be controlled in their different development stages, or better behaviour relating to production, for example grinding or mixing, storage or use.(page 13-14)
The unexpected results in the instant specification have been considered. However, unexpected results must be commensurate in scope with the claimed invention to be persuasive. The instant claims are not commensurate in scope compared to the unexpected results because they are not limited to the ratios in the examples, the concentrations in the examples, the stereoisomers in the examples, the carriers in the examples, the pesticide combinations that are in the examples, or the fungal pathogens the examples were tested against.
Claim(s) 1, 2, 5-7, 11, 12, 13, 14, 15, 16, 17, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over HONE (HONE et al., WO 2019158476 A1, 2019-08-22, IDS) in view of FABRI (FABRI et al., WO2018198009A1, 2018-11-01, IDS) further in view of O'SULLIVAN (O'SULLIVAN et al., WO 2013143811 A1, 2013-10-03).
The references HONE and FABRI has been discussed supra (and are incorporated by reference herein) and do not disclose the specific ratios of claims 2, 5-7 or 18.
The reference O'SULLIVAN teaches (page 15-27):
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The reference O'SULLIVAN teaches “A compound of formula (I) has been found to control the damage caused by a pest and/or fungi”(page 32) and “Compounds of this invention are effective for controlling nematode, insect, acarid pests and/or fungal pathogens of agronomic plants, both growing and harvested, when employed alone, they may also be used in combination with other biological active agents used in agriculture, such as one or more nematicides, insecticides, acaricides, fungicides, bactericides, plant activator, molluscicide, and pheromones (whether chemical or biological). Mixing the compounds of the invention or the compositions thereof in the use form as pesticides with other pesticides frequently results in a broader pesticidal spectrum of action. For example, the formula (I) compounds of this invention may be used effectively in conjunction or combination with pyrethroids, neonicotinoids, macrolides, diamides, phosphates, carbamates, cyclodienes, formamidines, phenol tin compounds, chlorinated hydrocarbons, benzoylphenyl ureas, pyrroles and the like.
The activity of the compositions according to the invention can be broadened considerably, and adapted to prevailing circumstances, by adding, for example, one or more insecticidally, acaricidally, nematicidally and/or fungicidally active agents. The combinations compounds of formula (I) with other insecticidally, acaricidally, nematicidally and/or fungicidally active agents may also have further surprising advantages which can also be described, in a wider sense, as synergistic activity. For example, better tolerance by plants, reduced phytotoxicity, pests or fungi can be controlled in their different development stages or better behaviour during their production, for example during grinding or mixing, during their storage or during their use”(page 40).
The reference O'SULLIVAN teaches “The mass ratio of of any two ingredients in each combination is selected as to give the desired, for example, synergistic action. In general, the mass ratio would vary depending on the specific ingredient and how many ingredients are present in the combination. Generally, the mass ratio between any two ingredients in any combination of the present invention, independently of one another, is from 100:1 to 1 :100, including from 99:1 , 98:2, 97:3, 96:4, 95:5, 94:6, 93:7, 92:8, 91 :9, 90:10, 89:1 1 , 88:12, 87:13, 86:14, 85:15, 84:16, 83:17, 82:18, 81 :19, 80:20, 79:21 , 78:22, 77:23, 76:24, 75:25, 74:26, 73:27, 72:28, 71 :29, 70:30, 69:31 , 68:32, 67:33, 66:34, 65:45, 64:46, 63:47, 62:48, 61 :49, 60:40, 59:41 , 58:42, 57:43, 56:44, 55:45, 54:46, 53:47, 52:48, 51 :49, 50:50, 49:51 , 48:52, 47:53, 46:54, 45:55, 44:56, 43:57, 42:58, 41 :59, 40:60, 39:61 , 38:62, 37:63, 36:64, 35:65, 34:66, 33:67, 32:68, 31 :69, 30:70, 29:71 , 28:72, 27:73, 26:74, 25:75, 24:76, 23:77, 22:78, 21 :79, 20:80, 19:81 , 18:82, 17:83, 16:84, 15:85, 14:86, 13:87, 12:88, 1 1 :89, 10:90, 9:91 , 8:92, 7:93, 6:94, 5:95, 4:96, 3:97, 2:98, to 1 :99. Preferred mass ratios between any two components of present invention are from 75:1 to 1 :75, more preferably, 50:1 to 1 .50, especially 25:1 to 1 :25, advantageously 10:1 to 1 :10, such as 5:1 to 1 :5, for example 1 :3 to 3:1 . The mixing ratios are understood to include, on the one hand, ratios by mass and also, on other hand, molar ratios.
Examples of application methods for the compounds of the invention mad compositions thereof, that is the methods of controlling pests / fungi in the agriculture, are spraying, atomizing, dusting, brushing on, dressing, scattering or pouring - which are to be selected to suit the intended aims of the prevailing circumstances”(page 58).
This helps to teach claims 2, 5-7 or 18.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified HONE and FABRI with O'SULLIVAN because all disclose fungicidal compositions for the same purpose of protecting useful plants from fungi and because O'SULLIVAN and HONE disclose the same compound. Thus it would have been obvious to use the ratios of compounds of those structures ( as taught by O'SULLIVAN) with combinations of other fungicidal compositions and optimize the ratio of compounds for synergy. "[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.) It thus would have been obvious to combine the cyclobutrifluram compositions of HONE and O'SULLIVAN with the Phenamacril compositions of FABRI to form a third composition for the very same purpose of protecting useful plants from fungi. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One would have a reasonable expectation of success because both compounds are suggested for combination with additional anti-fungi compounds. One would be motivated to do so because HONE teaches mixtures of the polymorph Form B or C with other active substances may also have further surprising advantages which can also be described, in a wider sense, as synergistic activity. For example, better tolerance by plants, reduced phytotoxicity, insects can be controlled in their different development stages, or better behaviour relating to production, for example grinding or mixing, storage or use.(page 13-14).
Response to Arguments
Applicant's arguments filed 09/24/2026 have been fully considered but they are not persuasive.
35 USC § 112
The argument against the 112b rejection due to the term “useful” having been removed is not persuasive as claim 13 still recites another copy of the term.
35 USC § 103
The arguments against the 103 rejections were not considered persuasive.
The applicant argued that:
The examiner failed to establish a prima facie case of obviousness due to a failure to establish a "reasonable expectation of success" because the surprising advantages of the combinations of the invention were not observed when the either benzovindiflupyr or either of the cyanoacrylate fungicides were not present in the combination, or when benzovindiflupyr was replaced by similar compounds." This was not considered persuasive for multiple reasons the first is it is obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose (antifungal activity), in order to form a third composition to be used for the very same purpose. One would have a reasonable expectation of success because both compounds are suggested for combination with additional anti-fungi compounds. This would have a reasonable expectation of success because Phenamacril is taught as a fungicide in its own right by itself (pages 11-12) and one would be motivated to do so because HONE teaches mixtures of the polymorph Form B or C with other active substances may also have further surprising advantages which can also be described, in a wider sense, as synergistic activity. Additionally, the argument that one would have no reasonable expectation of success when combining the two references because the synergistic activity requires benzovindiflupyr is also not persuasive because it would have been obvious to combine the cyclobutrifluram compositions of HONE with the Phenamacril compositions (including benzovindiflupyr) and this is also a composition of the instant invention because the instant invention uses the open ended comprising (see claim 1) and actually even suggests benzovindiflupyr in claim 11.
The applicant also argues that the unexpected results are reasonably commensurate in scope with the claimed invention. This was not found to be a persuasive argument because while a single member of a claimed subgenus, a narrow portion of a claimed range [can] be sufficient and it is not required to show unexpected results over the entire range of properties possessed it still must be reasonably commensurate in scope due to the large number of variables including ratios, additional pesticides, plant and fungi types the argument is not persuasive that it is reasonable commensurate in scope. For example, the claims to not read on any amounts (only ratios) and thus also read on trivial amounts for one or more components (including trace or contaminate amounts). In re Lindner, 457 F.2d 506, 509, 173 USPQ 356, 359 (CCPA 1972) (Evidence of nonobviousness consisted of comparing a single composition within the broad scope of the claims with the prior art. The court did not find the evidence sufficient to rebut the prima facie case of obviousness because there was "no adequate basis for reasonably concluding that the great number and variety of compositions included in the claims would behave in the same manner as the tested composition." Additionally, 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). As no error bars are given it is impossible to tell if the unexpected results are of statistical and practical significance.
Conclusion
Claims 1, 2, 5-7, 11, 12, 13, 14, 15, 16, 17, 18-21 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
