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 .
Claim Status
Claims 1-16 are pending and under examination.
Claim Objections
Claim 8 is objected to because of the following informalities: “apples characteristics” should read “apple characteristics”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: the claim recites “AVG” and “ACC” and while AVG and ACC are understood to be aminoethoxyvinylglycine and 1-amino-1-cyclopropanecarboyxlic acid, the full name of the terms should precede abbreviated terms the first time they are used. For example, aminoethoxyvinylglycine (ACC). Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) or pre-AIA 1st ¶
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 11-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to a method of enhancing apple coloration and a method of reducing fruit drop comprising applying a combination of ACC and AVG. The relative skill of those in the art is high. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the examiner cites Steyn (Stellenbosch University, 2020, pp. 1-136), were AVG (125 mg/L, i.e., 125 ppm), ACC (200 µL/L, i.e., 200 ppm), and a combination of AVG and ACC were tested on apples. Although ACC alone increased percentage blush coverage, the combination resulted in fruit color similar to untreated control. Likewise, AVG reduced fruit drop, while the combination performed similar to untreated control. Application timing was known to affect the results. Environmental factors light, temperature, as well as thinning, pruning, fertilization, irrigation, and chemicals, influence color development in apples (pg. 7 last full ¶, 3-3.3).
The breadth of the claims
The claims are thus very broad insofar as they suggest any combination of ACC and AVG, in any concentrations, timing, application rate, climate, and to any apple species, enhances apple coloration and reduces fruit drop.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful therapeutic protocols for enhancing apple coloration and reducing fruit drop other than the working embodiments, which disclose specific concentrations of ACC and AVG.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to enhance apple coloration and decrease fruit drop with any concentrations, any ratio, any application rate, to any apple species, as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 recites a method of enhancing apple characteristics selected from the group consisting of color coverage, color intensity, anthocyanin content coverage, anthocyanin intensity, background color, soluble solids content, fruit greasiness, starch patter index, internal ethylene concentration, watercore incidence, watercore breakdown, watercore severity, soggy breakdown, internal browning, superficial scald, and lenticel breakdown. Although the specification discuss the combination of AVG and ACC, and with embodiments directed to average % red pixel area, ground color, firmness, starch, brix (i.e., dissolved solids), apple coloration, fruit drop, and greasiness, the specification does not appear to provide written description support for internal ethylene concentration, watercore incidence, breakdown, and severity, soggy breakdown, internal browning, superficial scald, and lenticel breakdown, nor does the specification identify a particular relationship between the claimed mixture and the enhancement of the apple characteristics listed above that would reasonably convey to the skilled artisan that Applicant was in possession of the claimed invention.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 1-8 and 11, are rejected under 35 U.S.C. 103 as being unpatentable over Steyn (Stellenbosch University, 2020, pp. 1-136), in view of McArtney (Some Uses of Plant Growth Regulators in Modern Apple Production Systems, Apal, 2019, pp. 1-17).
Steyn teaches the combination of aminoethoxyvinylglycine (AVG, 125 mg/L) and 1-aminocyclopropane-1-carboxylic acid (ACC, 200 µL/L) were evaluated for their effects on red color, fruit quality, and maturity of Cripps Pink apples (pg. iv). The combination of AVG and ACC had a statistically significant improved percentage of starch conversion (Table 9 ACC + AVG, Table 10 ACC + AVG and AVG + ACC), percent total soluble solids (Table 13 ACC + AVG), compared to control. ACC was known to enhance ethylene production in fruit and subsequently stimulate red color development, although ripening is also advanced, resulting in risk of overripening (summary, pg. 1 2nd ¶, pg. 32 last ¶). To prevent this, AVG can be applied which inhibits the activity of ACC synthase (pg. 32 last ¶). AVG was known to delay red color development, as well as fruit ripening (summary, pg. 20 last ¶, pg. 35 1st ¶). Future research should be dedicated to establishing the optimum time of application of AVG in combination ACC should this prove to be an economically beneficial practice for increasing red color of fruit without negatively effecting maturity (pg. 42). AVG reduced fruit drop while ACC increased fruit drop (pg. 37 1st ¶, table 6).
Steyn does not teach the combination as a mixture.
McArtney teaches ReTain (AVG) combined with NAA, a plant growth regulator that increases ethylene levels in fruit that can trigger ripening, including fruit softening, were known to be formulated into a tank mix (pg. 13 3rd ¶, pg. 15 1st ¶). ReTain (AVG) inhibits suppresses the ethylene formation by NAA, so that the risk of NAA-induced softening is eliminated (pg. 15 1st ¶). The tank mix further included Silwet L-77 adjuvant, as the label of ReTain specifies it must be applied with an adjuvant (pg. 15 1st and 2nd ¶¶). The combination reduced fruit drop of apples (pg. 15 1st ¶).
Regarding claim 1, it would have been obvious to formulate the combination of AVG and ACC taught by Steyn in the form of a mixture, where McArtney teaches it was known to formulate AVG in combination with a plant growth regulator that increases ethylene formation as a tank mixture. The skilled artisan would have been motivated and have a reasonable expectation of success where the tank mixtures were effective in eliminating the risk of softening due to ethylene, and improving fruit control and fruit drop of apples, where both are directed to formulations comprising AVG in combination with AVG and a plant growth regulator that increases ethylene formulation.
Regarding claim 2, it would have been obvious to formulate the mixture with 125 mg/L AVG (i.e., 125 ppm) and 200 µL/L ACC (i.e., 200 ppm), resulting in a ratio of 125:200, or 1:1.6, falling within the claimed range.
Regarding claim 3, where the mixture made obvious above is formulated as a tank mix, it appears the limitation of a composition comprising the mixture of claim 1 is met.
Regarding claims 4 and 5, it would have been obvious to formulate the mixture with 125 mg/L AVG (i.e., 125 ppm) and 200 µL/L ACC (i.e., 200 ppm), falling within the claimed ranges.
Regarding claim 6, it would have been obvious to further include an excipient including the adjuvants taught by McArtney, were the references teaches that adjuvants are required in compositions comprising AVG.
Regarding claim 7, where the mixture made obvious above comprises AVG and ACC, and where Steyn teaches the combination had statistically improved starch conversion (Table 9 ACC + AVG, Table 10 ACC + AVG and AVG + ACC) and percent total soluble solids (Table 13 ACC + AVG) compared to control (tables 9, 10, 11, 12, 13), it would have been obvious to use the mixture for the method of enhancing starch conversion and percent total soluble solids, as taught by Steyn.
Regarding claim 8, where enhancing the starch conversion is made obvious above, it would have been reasonably expected that enhancement to the starch pattern index would naturally flow from the increase in starch conversion, where starch pattern index is a measure of starch in an apple.
Regarding claim 11, where Steyn contemplates the combination of ACC and AVG for increasing red color of fruit without negatively effecting maturity, teaches ACC was known to enhance red coloration though ethylene production, and AVG was known to delay red color development while decreasing the ripening effect of ACC, it would have been well within the relative skills of the skilled artisan to have routinely optimized the amount and ratios of AVG and ACC, in order to achieve enhanced apple coloration. It would have been reasonably expected that by increasing the concentration of ACC relative to AVG, that additional ethylene production would occur, thereby resulting in stimulation of red color development. 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. Where 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. See MPEP 2144.05(II)(A). Accordingly, it would have been obvious to apply a therapeutically effective amount of the AVG and ACC made obvious above to apples in order to enhance apple coloration.
Claims 9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Steyn (Stellenbosch University, 2020, pp. 1-136) and McArtney (Some Uses of Plant Growth Regulators in Modern Apple Production Systems, Apal, 2019, pp. 1-17), and further in view of Cetinbas et al (Erwebs-Obstbau, 2022, 64, 387–394, hereinafter “Cetinbas”).
Steyn and McArtney are discussed above but do not specifically teach the application rate of AVG in grams per hectare.
Cetinbas teaches it was known to apply ReTain (15% AVG) to improve fruit drop and fruit quality of apples in application rates of 830, 700, 550, and 400 g/ha (i.e., 124.5, 105, 82.5, and 60 g/ha AVG) (abs).
Where the combination of AVG and ACC is made obvious above, it would have been obvious to apply AVG in known rates suitable for treating apples, such as 124.5, 105, 82.5, and 60 g/ha, where these application rates were known to improve apple quality and reduce fruit drop, as taught by Centibas, falling within the claimed range. Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the application rate of AVG as it relates to ACC, in order to achieve desired and optimal apple characteristics, including apple color, for the same reasons discussed above.
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Steyn (Stellenbosch University, 2020, pp. 1-136) and McArtney (Some Uses of Plant Growth Regulators in Modern Apple Production Systems, Apal, 2019, pp. 1-17), and further in view of EPA (ACCEDE, Plant Growth Regulator Liquid Concentrate, 2021, pp. 1-12).
Steyn and McArtney are discussed above but do not specifically teach the application rate of ACC in grams per hectare.
EPA teaches ACC (as ACCEDE) plant growth regulator was known to be applied to apples and apple trees at 2.67 to 5.34 oz a.i. per acre, or 200 to 400 ppm ACC assuming a spray volume of 100 gallons per acre (pg. 6).
Where Steyn teaches 200 ppm ACC, and where ACC as a plant growth regulator was known to be applied to apples at 200 to 400 ppm ACC per 100 gallons per acre, it would have been obvious to apply the ACC made obvious above at an application rate of 187 g/ha (100 gal/acre = about 935 L/ha, 200 ppm = 0.2 g/L, 0.2 g/L x 935 L/ha = 187 g/ha of ACC). Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the application rate of ACC as it relates to AVG, in order to achieve desired and optimal apple characteristics, including apple color, for the same reasons discussed above. 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. Where 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. See MPEP 2144.05(II)(A).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Steyn (Stellenbosch University, 2020, pp. 1-136).
Steyn teaches the combination of aminoethoxyvinylglycine (AVG, 125 mg/L) and 1-aminocyclopropane-1-carboxylic acid (ACC, 200 µL/L) were evaluated for their effects on red color, fruit quality, and maturity of Cripps Pink apples (pg. iv). The combination of AVG and ACC had a statistically significant improved percentage of starch conversion (Table 9 ACC + AVG, Table 10 ACC + AVG and AVG + ACC), percent total soluble solids (Table 13 ACC + AVG), compared to control. ACC was known to enhance ethylene production in fruit and subsequently stimulate red color development, although ripening is also advanced, resulting in risk of overripening (summary, pg. 1 2nd ¶, pg. 32 last ¶). To prevent this, AVG can be applied which inhibits the activity of ACC synthase (pg. 32 last ¶). AVG was known to delay red color development, as well as fruit ripening (summary, pg. 20 last ¶, pg. 35 1st ¶). Future research should be dedicated to establishing the optimum time of application of AVG in combination ACC should this prove to be an economically beneficial practice for increasing red color of fruit without negatively effecting maturity (pg. 42). AVG reduced fruit drop while ACC increased fruit drop (pg. 37 1st ¶, table 6).
Regarding claim 14, where Steyn contemplates the combination of ACC and AVG for increasing red color of fruit without negatively effecting maturity, teaches ACC was known to increase red color of fruit, ripening and fruit drop, and AVG was known to delay fruit ripening, coloration, and decrease fruit drop, it would have been well within the relative skills of the skilled artisan to have routinely optimized the amount and ratios of AVG and ACC, in order to achieve desired reduction in fruit drop, while achieving benefits from ACC, such as coloration, etc.. It would have been reasonably expected that by increasing the concentration AVG relative to ACC, that delayed ripening would occur due to partial ethylene inhibition, thereby resulting in a reduced fruit drop. 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. Where 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. See MPEP 2144.05(II)(A). Accordingly, it would have been obvious to apply a therapeutically effective amount of the AVG and ACC, to an apple tree, in order to reduce fruit drop.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Steyn (Stellenbosch University, 2020, pp. 1-136), and further in view of Cetinbas et al (Erwebs-Obstbau, 2022, 64, 387–394, hereinafter “Cetinbas”).
Steyn is discussed above but do not specifically teach the application rate of AVG in grams per hectare.
Cetinbas teaches it was known to apply ReTain (15% AVG) to improve fruit drop and fruit quality of apples in application rates of 830, 700, 550, and 400 g/ha (i.e., 124.5, 105, 82.5, and 60 g/ha AVG) (abs).
Where the combination of AVG and ACC is made obvious above for reducing fruit drop, it would have been obvious to apply AVG in known rates suitable for treating apples, such as 124.5, 105, 82.5, and 60 g/ha, where these application rates were known to improve apple quality and reduce fruit drop, as taught by Centibas, falling within the claimed range. Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the application rate and ratios of AVG and ACC, in order to achieve desired reduction of fruit drop. It would have been reasonably expected that by increasing the application rate or amount of AVG relative to ACC, that delayed ripening would occur due to partial ethylene inhibition, thereby resulting in a reduced fruit drop. 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. Where 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. See MPEP 2144.05(II)(A).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Steyn (Stellenbosch University, 2020, pp. 1-136), and further in view of EPA (ACCEDE, Plant Growth Regulator Liquid Concentrate, 2021, pp. 1-12).
Steyn is discussed above but do not specifically teach the application rate of ACC in grams per hectare.
EPA teaches ACC (as ACCEDE) plant growth regulator was known to be applied to apples and apple trees at 2.67 to 5.34 oz a.i. per acre, or 200 to 400 ppm ACC assuming a spray volume of 100 gallons per acre (pg. 6).
Where Steyn teaches 200 ppm ACC, and where ACC as a plant growth regulator was known to be applied to apples at 200 to 400 ppm ACC per 100 gallons per acre, it would have been obvious to apply the ACC made obvious above at an application rate of 187 g/ha (100 gal/acre = about 935 L/ha, 200 ppm = 0.2 g/L, 0.2 g/L x 935 L/ha = 187 g/ha of ACC). Further, it would have been well within the relative skills of the skilled artisan to have routinely optimized the application rate of ACC as it relates to AVG, in order to achieve desired and optimal apple characteristics, in order to achieve desired and optimal fruit drop reduction, while achieving benefits from ACC, were it would have been reasonably expected that by increasing the application rate of AVG relative to ACC, that delayed ripening would occur due to partial ethylene inhibition, thereby resulting in a reduced fruit drop. 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. Where 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. See MPEP 2144.05(II)(A).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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