DETAILED ACTION
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 11-14 and 16 are pending in the present 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.
The factual inquiries 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 11-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tayler (US 5,244,866) in view of Gunsolus et al. (Herbicide mode of action and injury symptoms, 1991).
Regarding instant claim 11, Tayler teaches a method for inhibiting sprout formation on tubers comprising administering to said tubers an effective sprout inhibiting amount of an imidazolinone (Claim 1). Tayler teaches that imidazolinones are part of a class of herbicides that inhibit acetohydroxyacid synthase (AHAS), the enzyme responsible for the synthesis essential of amino acids in plants. Such AHAS inhibiting herbicides have been shown to produce growth regulating biological effects on agronomic crops. For example, U.S. Pat. No. 4,957,536 refers to the use of imidazolinones to increase axillary branching, tillering, flowering and yield of growing agronomic and horticultural crops. Surprisingly, we have found that certain AHAS inhibiting herbicides, in particular imidazolinones, are unexpectedly effective in inhibiting sprout formation in tubers and bulbs. As used herein, agronomic crops include, for example, bulbs, such as onions, and tubers, such as carrots, turnips, beets, radishes and especially, potatoes (col. 2, ln. 19-37).
Tayler teaches that this invention, for the first time, provides a safe and effective treatment for inhibiting sprout formation on fleshy roots and stems, such as tubers or bulbs, preferably while in storage. The treatment comprises the application of an effective sprout inhibiting amount of an AHAS inhibiting herbicide, for example, sulfonylureas, sulfamoylureas (sulfonamides), triazolopyrimidines and especially, imidazolinones, or combinations thereof, to agronomic crops before, or preferably after harvest. Preferred AHAS inhibiting herbicides in accordance with this invention are imidazolinones, such as those described in U.S. Pat. No. 4,798,619 which is incorporated herein by reference. More preferred are imazapyr and imazethapyr. Most preferred is imazethapyr (col. 2, ln. 38-53).
Tayler does not explicitly disclose that the imidazolinones include imazamox, as instantly claimed.
However, Gunsolus et al. teach that imazamox, imazapyr and imazethapyr are all imidazolinone herbicides with the site of action being inhibition of acetolactate synthase (ALS) (Table 3).
It would have been prima facie obvious for a person of ordinary skill in the art to substitute imazamox in the place of the imidazolinones of Tayler since Gunsolus et al. teach that they are functionally equivalent ALS inhibitors and imidazolinone herbicides. A person of ordinary skill in the art would have been motivated to include imazamox in the formulations of Tayler because Gunsolus et al. teach that imazapyr, imazethapyr and imazamox are all functionally equivalent ALS inhibiting imidazolinone herbicides. Thus, a person of ordinary skill in the art would reasonably expect imazamox to be similarly effective for inhibiting sprout formation as the imidazolinone compounds taught by Tayler.
Regarding the concentration of imazamox being 100 to 250 grams per liter, Tayler teaches that when mixed in aqueous solution, the herbicide dose is generally between about 50 ppm and 1000 ppm, i.e., between about 0.05 g and 1 g per liter of aqueous solution per ton of crop. Higher doses of AHAS inhibiting herbicides, however, may be used for certain agronomic crop according to the particular application without departing from the scope of this invention. For example, up to about 5000 ppm or more may be used, depending on the particular crop, particular treatment combination, and the ambient conditions (col. 3, ln. 3-12).
Tayler teaches that the amount of herbicide, or combination of herbicides, effective as a sprout suppressant will vary somewhat according to the particular herbicide(s), the type and the amount of the crop, the duration of storage and the size and configuration of the storage container, the environment in which the treatment is administered, and the like. As described above, about 50 ppm-1000 ppm in an aqueous solution is effective for most applications. Application of the herbicidal compositions at such rates is not only effective at inhibiting sprout formation but shows reduced toxicity compared to other fumigant sprout suppressants, particularly when imdiazolinones are used. Another advantage of these com positions is that they are stable for long periods of time at room temperature (col. 3, ln. 23-37).
Tayler further teaches that the herbicidal compositions may also be formulated as emulsifiable concentrates, flowable liquid concentrates, or wettable powders which are diluted with water, other suitable polar solvent or oil carrier, generally in situ, and then applied as a dilute spray. Said compositions may also be formulated in suspension concentrates, microemulsions, and the like, all of which lend themselves to plant (foliage), root, stem, seed, tuber, or bulb applications to provide the requisite sprout suppression (col. 3, ln. 38-47).
Tayler teaches that a typical emulsifiable concentrate can be prepared by dissolving about 5% to 50% by weight of the active ingredient in about 95% to 50% by weight of a solvent (col. 3, ln. 66-68). The compositions of the invention are prepared for use by adding a predetermined quantity of formulated product, such as described above, to the desired volume of water, other suitable solvent or liquid or solid carrier, alone or in combination with one or more other agronomic chemicals for sequential or simultaneous use (col. 4, ln. 6-11).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare a concentrate comprising up to 50% by weight of imazamox, wherein the composition is diluted with water for use, as suggested by Tayler.
Regarding instant claim 12, Tayler teaches a method of inhibiting sprouting of tubers, such as carrots, turnips, beets, radishes and especially, potatoes (col. 2, ln. 11-62; Claims 1-15). Tayler teaches applying the herbicide composition to the tubers to inhibit sprout formation (col. 2, ln. 41-46; Claim 1).
Regarding instant claim 13, Tayler teaches that the imidazolinone can be administered as a spray or as an aerosol (col. 2, ln. 54-62; Claims 8-9).
Regarding instant claim 14, Tayler teaches diluting the imidazolinones with an aqueous solution prior to application to the crop (col. 2, ln. 67 to col. 3, ln. 3).
Regarding instant claim 16, Tayler teaches that an important consideration for distribution and sale of agronomic crops is the total time from harvest to ultimate consumer use. Unfortunately, crops are often stored for long periods of time prior to their ultimate use. Efforts have been made to minimize this time period and to extend the useful life of the crop such that it retains its utility and commercial appeal (col. 1, ln. 28-34). Tayler teaches that it is an object of their invention to provide a post-harvest sprout inhibiting treatment for tubers and bulbs which is easily and uniformly applied in a single treatment (col. 1, ln. 67 to col. 2, ln. 2). Tayler further teaches that, except for Romano, which has a long dormancy, one treatment of imazethapyr at 250 ppm was as good as or better than three applications of the standard material (col. 6, ln. 49-54).
However, Tayler teaches that the sprout development was only assessed at about 8 weeks and 18 weeks post treatment. A person of ordinary skill in the art would have been motivated to determine through routine experimentation the frequency of application of the imidazolinone compounds according to Tayler for inhibiting tuber sprout formation during long term storage, such as longer than the 18 week assessment period shown in the examples. A person of ordinary skill in the art would have been motivated to determine the necessary frequency of application in order to maintain the utility and commercial appeal of the crop.
Response to Arguments
Applicant's arguments filed 21 August 2025 have been fully considered but they are not persuasive. Applicant argues that Tayler does not mention imazamox at all, nor does it provide any data, examples, or rationale for its use in sprout inhibition of potatoes. Tayler’s disclosure is limited to imazethapyr and imazapyr as preferred compounds, with imazethapyr being most preferred. The mere listing of imidazolinones as a class does not provide a teaching or suggestion to specifically use imazamox, especially in the absence of any indication that imazamox would be effective or safe for this purpose. Gunsolus only lists imazamox as an ALS inhibitor in a table of herbicide families and does not discuss its use for sprout inhibition, let alone in potatoes. There is no teaching, suggestion, or motivation in either reference to select imazamox for sprout inhibition in potatoes, and no reasonable expectation of success is provided by the prior art for this specific application.
The examiner respectfully directs attention to MPEP 2123(I) and (II):
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he 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….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
The Supreme Court in KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. One such rationale includes the simple substitution of one known element for another to obtain predictable results. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. See MPEP 2143.
Tayler teaches that their invention provides a safe and effective treatment for inhibiting sprout formation on fleshy roots and stems, such as tubers or bulbs, preferably while in storage. The treatment comprises the application of an effective sprout inhibiting amount of an AHAS inhibiting herbicide, for example, sulfonylureas, sulfamoylureas (sulfonamides), triazolopyrimidines and especially, imidazolinones, or combinations thereof, to agronomic crops before, or preferably after harvest. Preferred AHAS inhibiting herbicides in accordance with this invention are imidazolinones, such as those described in U.S. Pat. No. 4,798,619 which is incorporated herein by reference. More preferred are imazapyr (Arsenal®; American Cyanamid Co.) and imazethapyr (Pursuit®; American Cyanamid Co.). Most preferred is imazethapyr (col. 2, ln. 38-53).
Therefore, Tayler teaches that AHAS inhibiting imidazolinone herbicides are suitable for inhibiting sprout formation on fleshy roots and stems, such as tubers or bulbs, preferably while in storage. In view of the teaching of Gunsolus et al. that imazamox, imazapyr and imazethapyr are all imidazolinone herbicides with the site of action being inhibition of acetolactate synthase (ALS or AHAS) (Table 3); a person of ordinary skill in the art would have a reasonable expectation that imazamox would be suitable for use in the invention of Tayler.
Applicant argues that moreover, the claimed invention requires treating potato tubers with a composition comprising 100 to 250 grams per liter of imazamox. Tayler’s examples and preferred application rates are orders of magnitude lower, specifically 50 to 1000 ppm (0.05 to 1 g/L) for use in sprout inhibition. While Tayler does mention that higher doses may be used for certain crops, there is no teaching or suggestion to use concentrations in the range of 100 to 250 g/L for application to potatoes. The Office’s reliance on Tayler’s disclosure of concentrate formulations containing up to 50% by weight of active ingredient is misplaced, as these concentrates are intended to be diluted prior to application. The claims, by contrast, require the actual treatment of potatoes with a composition at the specified high concentration, not merely the preparation of a concentrate. There is no evidence in the prior art that such high concentrations are effective or safe for sprout inhibition in potatoes, nor any motivation to use them.
Regarding the concentration, the examiner respectfully argues that instant claim 14 requires diluting the composition by mixing the composition with an aqueous liquid prior to applying. Therefore, the concentration of imazamox applied to the potato tubers in claim 14 is less than 100 to 250 grams per liter.
Also, Tayler teaches that a typical emulsifiable concentrate can be prepared by dissolving about 5% to 50% by weight of the active ingredient in about 95% to 50% by weight of a solvent (col. 3, ln. 66-68). The compositions of the invention are prepared for use by adding a predetermined quantity of formulated product, such as described above, to the desired volume of water, other suitable solvent or liquid or solid carrier, alone or in combination with one or more other agronomic chemicals for sequential or simultaneous use (col. 4, ln. 6-11).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare a concentrate comprising up to 50% by weight of imazamox, wherein the composition is diluted with water for use, as suggested by Tayler.
Furthermore, a person of ordinary skill in the art would have been able to determine through routine experimentation the effective concentration of imazamox for the inhibition of sprouting of potato tubers within the concentration range taught by Tayler.
Applicant further asserts that obviousness requires not only that the prior art provides a motivation to combine or modify known elements, but also that there is a reasonable expectation of success. In this case, neither Tayler nor Gunsolus provides any data or rationale suggesting that imazamox would be effective for sprout inhibition in potatoes, particularly at the claimed concentrations. Tayler’s data and examples are limited to imazethapyr and imazapyr, and there is no indication that imazamox would perform similarly. Gunsolus discusses herbicide mode of action and injury symptoms, not sprout inhibition. The claimed invention demonstrates, through experimental data in the specification, that imazamox provides surprising efficacy and selectivity for sprout inhibition in potatoes, with reduced phytotoxicity compared to other treatments (see SPEC, Examples 2-3). These results are not predictable from the prior art and provide strong evidence of nonobviousness.
Applicant argues that still further, the specification provides robust experimental data showing that imazamox, when used at the claimed concentrations, is highly effective in inhibiting sprout formation in potatoes, with minimal phytotoxicity and superior performance compared to other sprout inhibitors such as maleic hydrazide and CIPC (see SPEC, Tables 3-5). These unexpected results are not suggested or predictable from Tayler or Gunsolus, which do not disclose or contemplate the use of imazamox for this purpose or at these concentrations.
The examiner respectfully argues that the instant specification, Examples 2-3, Tables 1-5, do not clearly disclose application of a composition comprising 100-250 g/l of imazamox to potato tubers.
Example 1 prepares a concentrated composition comprising 40 g/L imazamox, and states that the concentrated imazamox composition was diluted in an aqueous liquid, in particular water, to form a diluted liquid composition, which is to be applied as a spray onto potatoes. The example does not state how much the composition is diluted for application as a spray onto potatoes. Thus, it is unclear what the imazamox concentration is in the diluted liquid composition to be applied to potatoes.
Example 2 states applying the composition of the present invention to potatoes at an application rate of 400 ml/1000 kg (Table 1). One interpretation is that 400 ml of the composition of the present invention is applied per 1000 kg of potatoes, but it is not clear what the imazamox concentration is in the 400 ml being applied. In an alternatively interpretation, 400 ml of the composition of the present invention is diluted by combining with 1000 kg of water. However, it is still unclear what the imazamox concentration is in the initial 400 ml before dilution with the 1000 kg water. If the initial composition is the concentrate from Example 1, i.e., 40 g/l, then the concentration of imazamox after 400 ml is diluted with 1000 kg of water would be 16 g imazamox in approximately 1000.4 liters of water, or approximately 0.016 g/l of imazamox.
Example 3 states an application rate of 12-30 g a.i./1000 kg (Table 3), as well as 50-250 ml/1000 kg (Tables 4-5). However, the example does not state the concentration of imazamox in the composition being applied to the potatoes. If the volume is the same as Example 2, i.e., 400 ml/1000 kg, then the concentration of imazamox would be 12-30 grams per 400 ml (i.e., 30-75 grams imazamox per liter solution).
Therefore, it is not clear what concentration of imazamox is being applied to the potatoes in the examples; and the examples do not provide data showing the treatment of potatoes with a composition comprising 100-250 g/L of imazamox.
Also, regarding reasonable expectation of success, the examiner respectfully argues that Tayler teaches application of imidazolinones on tubers, such as potatoes, to inhibit the post-harvest growth of sprouts. Tayler further teaches that imidazolinones are part of a class of herbicides that inhibit AHAS, and the preferred imidazolinones are imazapyr and imazethapyr. Gunsolus et al. teach that imazamox, imazapyr and imazethapyr are all imidazolinone herbicides with the site of action being inhibition of acetolactate synthase (ALS, also known as AHAS) (Table 3). Therefore, a person of ordinary skill in the art would have a reasonable expectation that imazamox, a functionally equivalent imidazolinone herbicide, would be suitable for use in the invention of Tayler.
Applicant also argues that the Office’s rejection appears to be based on hindsight reconstruction, using the applicant’s own disclosure as a roadmap to combine elements from the prior art that are not actually taught or suggested in combination. The prior art does not provide any motivation to use imazamox for sprout inhibition in potatoes, nor to use the claimed concentration range.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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/N.W.S/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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