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 .
Status of Action/Claims
Receipt of Remarks/Amendments filed on 11/3/2025 is acknowledged. Claims 1-3, 7, 10-13, 15-17 and 19-24 are currently pending and presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Withdrawn Rejections
Applicant’s arguments/amendments, filed 11/3/2025, with respect to the previous claim objections have been fully considered and are persuasive. The previous claim objections have been withdrawn due to claim amendments.
Applicant’s arguments/amendments, filed 11/3/2025, with respect to the previous 112(b) rejections have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn due to claim amendments.
Applicant’s arguments/amendments, filed 11/3/2025, with respect to the 103 rejection over Coleman in view of FR2405650 have been fully considered and are persuasive. The rejection has been withdrawn due to claim amendments which require the composition does not include a fatty acid.
New/Maintained Claim Objection(s) / Rejection(s)
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 1-3, 7, 10-13, 15-17 and 19-24 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.
Claims 1 and 24 recite a composition comprising an active ingredient consisting of phenylalanine in a concentration ranging from 0.5-30 mM, and does not include a fatty acid or salt thereof, and optionally at least one additional agricultural agent. The way this recitation is phrased makes it unclear whether the composition does not include refers only to a fatty acid or salt thereof or whether it also refers to the composition does not include at least one additional agricultural agent. In light of the previous claims set (3/26/2025), it appears the claims allow for optionally including additional agricultural agent. Thus, the examiner suggests that claim can be amended to recite “a composition comprising an active ingredient consisting of phenylalanine in a concentration ranging from 0.5-30 mM, optionally at least one additional agricultural agent, and the composition does not include a fatty acid or salt thereof”.
Claims 2-3, 7, 10-13, 15-17 and 19-23 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
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 of this title, 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.
Claims 1-3, 7, 10-13, 15-17 and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over FR2405650 in view of Coleman (US 2004/0266852 A1; Dec. 30, 2004), Egel (Purdue Extension Publication, Dec. 2015) and Juma (Biological Control, Volume 90, November 2015, Pages 92-95).
FR2405650 discloses an example of the practical conditions for treatment with (L) phenyl alanine, in the case of fusarium silt tomatoes. Phenyl alanine is dissolved in water (carrier). (page 3, lines 82-86, Translation).
Plantlets of lycopersicum esculentum, variety Saint-Pierre, are cultivated (page 3, lines 8-89, Translation) (claim 15, tomato).
Twelve days after emergence, when the seedlings have two developed leaves, following immersion in the mineral medium (claim 11 - applying pre-harvest, claim 12 - blossom stage), the tanks are immersed daily for 10 hours in a solution of (L) phenyl alanine M/100 this for 3 consecutive days (repeated application) (page 3, lines 95-97, Translation). The reference teaches immersion of developed leaves in a solution of phenylalanine. FR2405650 also discloses the treatment of plants infested by fungi is carried out by periodically watering the crops with aqueous solution of phenylalanine (page 2, line 69-70, Translation).
After the 3 days of treatment, the plantlets to be inoculated are pulled up. After washing the roots, their ends are cut to facilitate the penetration of the pathogen. The root system is then immersed for two hours in a suspension of conidia containing on the order of 8 to 10 x106 conidia/ml of Fusarium oxysporum F. sp. Lycopersici (page 3, lines 100-104, Translation). To estimate the severity of the disease triggered by fusarium, the size of the plants is measured as a function of time, the date of infestation, being time zero of the experiment, only aerial part being considered (page 3, lines 112-114, Translation). The treatment carried out with (L) phenyl alanine M/100 completely protects the tomato plants from Fusarium wilt and that the size of the plants is not influenced by the treatment with (L) phenyl alanine (page 4, lines 131-133, Translation). The reference teaches using ~10 mM concentrated phenylalanine (phenylalanine’s MW as 165g/mol, and the reference teaches dissolving 1.65g of phenylalanine in 1L volume) (page 3, line 85, Translation). Thus, the amount of approximately 10mM phenylalanine taught by FR2405650 is effective to inhibit germination of fungal spores (Fusarium oxysporum) because FR2405650 teaches this amount of phenylalanine completely protects the tomato plants from Fusarium wilt. Moreover, the instant specification (Fig. 1A – Fig. 1E) disclose 15 mM of phenylalanine being effective to reduce necrosis or chlorosis and approximately 10 mM of phenylalanine taught by FR2405650 reads on 15 mM of phenylalanine.
The reference teaches carrying out the treatment in “a condition room” (page 3, lines 100+, Translation), which reads on the “storage facility” as the term can be broadly and reasonably interpreted to be any room.
The teachings of FR2405650 have been set forth above.
As discussed supra, FR2405650 discloses the treatment of plants infested by fungi can be carried out by periodically watering the crops with aqueous solution of phenylalanine. FR2405650 does not teach the application method comprises spraying and wherein the composition is formulated as a spray. FR2405650 also does not teach spraying specifically flower of the plant and wherein repeated spraying comprises weekly spraying said flower of said plant during blossom pre-harvest. FR2405650 also does not teach the particular fungal infection of the plant such as the ones recited in instant claims 7 and 10. However, these deficiencies are cured by Coleman, Egel and Juma.
Coleman teaches a method of controlling fungal infection in crops, said method comprising applying to the crop an effective amount of a fungicidal composition comprising a fatty acid or a salt thereof and an organic carboxylic acid different from the fatty acid, selected from phenylalanine and tyrosine. The composition can be applied to flower, leaves or any other component of a plant before or after harvesting. (claims 1, 9, 20, 26-28; para 0021; 0015). The composition can be provided and applied to the crops either as a spray or dipped solution and can be used as a single or multiple treatment application. Coleman teaches the agricultural composition can be applied either as a pre-emergent, post-emergent, foliar or post-harvest application (pre-harvest, post-bloom stage, bloom stage, or pre-bloom stage). (para 0015; 0026; 0032). Coleman teaches fungus is selected from Botrytis cinereal and Alternaria sp. (Para 0033). Coleman also teaches phenylalanine exhibits fungicide activity against Pythium species. (Para 0033).
Egel discloses tomato plants are known to have fungal infection caused by Botrytis cinereal (gray mold) and Sclerotinia sclerotiorum (white mold) (see: Pages 2 and 3). Juma reference teaches tomato plants are known to have fungal infection caused by Pythium aphanidermatum (see: Pages 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teachings of FR2405650, Coleman, Egel and Juma and use phenylalanine taught by FR2405650 for controlling fungal infection caused by Botrytis cinereal and Pythium aphanidermatum in plants such as tomato plant. Coleman teaches the use of phenylalanine for controlling fungal infections caused by Botrytis cinereal and Pythium species, Egel discloses tomato plants are known to have fungal infection caused by Botrytis cinereal (gray mold) and Sclerotinia sclerotiorum and Juma teaches tomato plants are known to have fungal infection caused by Pythium aphanidermatum. Since FR2405650 teaches applying phenylalanine to tomato plant to control fungal infections, one would have been highly motivated to use phenylalanine to control fungal infections caused by Botrytis cinereal and Pythium aphanidermatum in tomato plants because Egel and Juma teach tomato plants are known to have fungal infection caused by Botrytis cinereal and Pythium aphanidermatum and Coleman teaches the use of phenylalanine for controlling fungal infections caused by Botrytis cinereal and Pythium species.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teachings of FR2405650, Coleman, Egel and Juma and apply the composition of FR2405650 as a spray as taught by Coleman because this method of application of phenylalanine for controlling fungal infection in plants was known in the art as shown by Coleman. Particularly, FR2405650 discloses application can be carried out by watering the crops with phenylalanine composition and watering encompasses spraying. Since Coleman teaches composition comprising phenylalanine can be applied by spraying, it would have been obvious to skilled artisan to use this method for application of the composition of FR2405650.
It would also have been obvious to one skilled in the art to spray specifically flower of the plant and wherein repeated spraying comprises weekly spraying said flower of said plant during blossom pre-harvest. As discussed supra, FR2405650 teaches repeated application of the composition to leaves of the plant during pre-harvest and blossom stage, and Coleman teaches composition comprising phenylalanine to control fungal infection can be applied, in multiple treatments, to flower, leaves or any other component of a plant before harvesting during bloom stage. Therefore, it would have been obvious to one skilled in the art to apply the composition to flower or leaves of the plant because both Coleman and FR2405650 are directed to controlling fungal infection in plants and Coleman teaches the composition can be applied to leaves or flower. With respect to the method step of weekly application, it would have been obvious to one skilled in the art to manipulate and optimize the frequency of application which would depend on the severity of fungal infection, and size and number of crops being treated.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made because every element of the invention has been fairly suggested by the cited references.
Response to Arguments
Applicant argued that FR240650 reference teaches immersion and watering methods for delivering phenylalanine to plant roots to treat tracheomycoses, which are systemic fungal infections. The reference explicitly describes immersing plantlets in phenylalanine solution and watering crops with aqueous phenylalanine solution. Importantly, FR2405650 teaches away from foliar applications by explicitly stating that phenylalanine cannot be utilized for controlling phytopathogenic parasites that induce infections of plant foliage, such as downy mildew. This teaching away is directly contrary to the claimed method, which specifically requires spraying the composition onto plant surfaces including fruits, leaves, seeds, and flowers.
In response, while FR2405650 discloses that development of tomato downy mildew is not inhibited by the treatment method of the invention, applicant have not clearly pointed out how this disclosure suggests that phenylalanine would fail to control or inhibit the fungus species recited in instant claims. Further, as discussed supra, FR2405650 teaches applying to the plant (i.e., tomato plant) ~10 mM of phenylalanine. As disclosed by the Egel reference, tomato plants are known to have fungal infection caused by Botrytis cinereal (gray mold) and Sclerotinia sclerotiorum (white mold) (see: Pages 2 and 3). Also, as disclosed by Coleman, phenylalanine was known to be used against fungal infection caused by Botrytis cinereal (Para 0033; Claim 1). Since FR2405650 teaches the method of applying to the plant (i.e., tomato plant) ~10 mM of phenylalanine as required in the instant claims, the method taught by the reference would necessarily result in controlling the fungus infection caused by the fungus recited in the instant claim because tomato plants are capable of fungal infection caused by Botrytis cinereal (gray mold) and Sclerotinia sclerotiorum (white mold) and phenylalanine was known to have antifungal properties against the fungus recited in the instant claims. FR2405650 discloses twelve days after emergence, when the seedlings have two developed leaves, following immersion in the mineral medium, the tanks are immersed daily for 10 hours in a solution of (L) phenyl alanine M/100 for 3 consecutive days. This teaching indicates that seedings that have 2 leaves are treated with (L) phenyl alanine M/100. FR2405650 further discloses that the treatment carried out with (L) phenyl alanine M/100 completely protects the tomato plants against Fusarium wilt. This teaching indicates that (L) phenyl alanine protects the tomato plants. The tomato plant includes the fruit and leaves of the tomato plant. The cited prior art teaches the same method as recited in the instant claims, therefore, the properties possessed by the composition of the instant application, control of fungus infection in the fruit, the leaf, the seed, or the flower, would be possessed by the prior art. Where the claimed and prior art product(s) are identical or substantially identical, the burden of proof is on applicant to establish that the prior art product(s) do not necessarily or inherently possess the characteristics of the instantly claimed product(s), see In re Best, 195 USPQ 430.
With respect to applicant’s arguments regarding Coleman, as discussed supra, the 103 rejection over Coleman in view of FR2405650 has been withdrawn because Coleman requires the composition include a fatty acid which is excluded from the instant claims.
Applicant argued that the specific concentration range of 0.5-30 mM recited in claims 1 and 24 represents a critical limitation that is not taught or suggested by the cited references.
In response, while applicant argue of the claimed amount being critical for controlling fungal infection, the applicant have not shown or provided and data which supports that the claimed amount of phenylalanine is critical and possess unexpected results over the amounts taught in the prior art. “The arguments of counsel cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 145 USPQ 716, 718 (CCPA 1965), In re Huang, 40 USPQ 2d 1685 (Fed. Cir. 1996), In re De Blauwe et al., 222 USPQ 191, (Fed. Cir. 1984). Applicant has not provided any factual evidence establishing unobviousness. Thus, applicant need to bring forth experimental data/results which support the argument that the claimed amount of phenylalanine is critical. In addition, one of ordinary skill in the art would have been motivated to use known application rates and experiment to optimize the amount of phenylalanine needed in the composition to provide fungicidal protection of the fruit, the leaf, the seed, or the flower. The adjustment of conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited reference) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Applicant also argued that Coleman focuses on post-harvest treatment and dipping applications for harvested products, whereas the claimed invention specifically targets pre-harvest foliar fungal infections through repeated spraying during plant growth stages, representing a different application and technical problem than Coleman addresses.
In response, as discussed supra, Coleman teaches the composition can be applied to flower, leaves or any other component of a plant before or after harvesting. (claims 1, 9, 20, 26-28; para 0021; 0015). The composition can be provided and applied to the crops as a spray and can be used as a single or multiple treatment application. Coleman teaches the agricultural composition can be applied either as a pre-emergent, post-emergent, foliar or post-harvest application (pre-harvest, post-bloom stage, bloom stage, or pre-bloom stage). (para 0015; 0026; 0032). While Coleman in claims 20 and 29 discloses application after harvesting, Coleman in its disclosure clearly states the application can be before harvesting or after harvesting. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 7, 10-13, 15-17 and 19-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11812746B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘746 patent claims a method of treating a fungus infection in a fruit, a leaf, a seed, or a flower of a plant, the method comprising selecting a plant infected with a fungus selected from the group consisting of Botrytis, Plenodomus tracheiphilus syn Phoma tracheiphila, Sclerotinia sclerotiorum, Pythium aphanidermatum and Alternaria; and applying to said plant infected with said fungus a composition comprising a carrier and active agent, wherein said active agent consists of 2-30 mM of phenylalanine for treating said fungus infection. Applying comprises pre-harvest applying or post-harvest applying. Said plant is at a post-blossom stage, at a blossom stage, or at a pre-blossom stage. Phenylalanine is formulated in a composition selected from the group consisting of a dip, a spray or a concentrate. Applying is by irrigation, drenching, dipping, soaking, injection, coating or spraying. Plant is selected from the group consisting of petunia, tomato, sweet basil, cucumber, avocado, strawberry, grape, apple, blueberry, cherry, bean, cabbage, carrot, onion and lemon. Applying is in a storage facility. Applying comprises repeated application. Applying comprises weekly administration during blossom pre-harvest. Applying is by spraying.
The difference between the instant claims and ‘746 patent is that the instant claims recite a method of controlling a fungus infection and ‘746 recites a method of treating a fungus infection. However, treating a fungus infection would constitute controlling of the fungus infection and therefore the instant claims and ‘746 patent claims overlap and the limitations “treating” and “controlling” are obvious variants of one another.
Response to Arguments
Applicant have not provided any arguments related to the double patenting rejection above and therefore, the rejection is maintained.
Conclusion
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.S/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616