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 .
Status of the Claims
The listing of claims filed 07 August 2024 has been examined.
Claims 1-15 and 19-22 are pending.
Claims 1-15 are amended.
Claims 19-22 are newly added.
Claims 16-18 are cancelled.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 07 August 2024 and 20 August 2024 are acknowledged and have been considered.
Benefit of Earlier Filing Date
The instant application was received 07 August 2024; it is a national stage application of PCT/CZ2022/050015, filed 09 February 2022. Acknowledgment is made of Applicant’s claim.
Note a copy of PCT/CZ2022/050015 has not been received, so Examiner requests a copy of PCT/CZ2022/050015 be submitted.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains legal phraseology, specifically the term “comprising.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “…poly-y-(glutamic acid), diethyl aminoethyl hexanoate, N-acetyl thiazolidine 4-carboxylic acid.” The word “and” appears to be missing. Accordingly, Examiner suggests amending to, “…poly-y-(glutamic acid), diethyl aminoethyl hexanoate, and N-acetyl thiazolidine 4-carboxylic acid.” [Emphasis added.] Appropriate correction is requested.
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.
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 1-6, 8-15, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Nisler (WO 2016/037595 A1; IDS dated 07 August 2024, Cite No. 1) in view of Davison (US 2014/0274719 A1).
Regarding claims 1, 6, 9, 12-13, and 15, Nisler teaches a method by which 1,2,3-thiadiazol-5-yl-urea derivatives, including 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea (p. 3, Line 28; p. 10, Lines 35-36; p. 14, Line 9), are used on plants (p. 1, Lines 6-8). Nisler indicates said derivatives can be used as “…inhibitors of stress and stress-induced senescence in the production of crops…” like cereals, beets, pomes, drupes, soft fruits, leguminous plants, oil plants, cucumber plants, fibre plants, citrus fruits, vegetables, tobacco, nuts, eggplants, sugar cane, tea, vine grapes, hops, bananas, natural rubber, medicinal plants, and ornamentals (p. 7, Lines 5-20). Nisler discloses exemplary compositions, like dusts and wettable powders, containing 0.5-90% weight active ingredient mixture, 0.5-20% surfactant, and 5-95% solid carrier (p. 9, Lines 24-26). In one composition, Nisler describes a wettable powder containing 2-4% weight sodium lauryl sulfate (p. 30, Line 12), which a skilled artisan would recognize as an excipient, specifically a surfactant. Additionally, Nisler suggests, “The compositions may also comprise further ingredients, such as… fertilisers or other active ingredients.” (p. 9, Lines 32-35) and indicates the compounds may be applied to whole plants, plant organs, or in vitro plant cells (p. 6, Lines 28-29).
Nisler does not explicitly teach a nitrogen utilization enhancer, such as pyroglutamic acid and/or phosphite.
Davison teaches fertilizer compositions containing macronutrients, micronutrients, a plant growth regulator, and optional additional components (p. 1, ¶ [0015]). The macronutrients may include phosphite (p. 4, Claim 3) in an amount ranging from about 0.1-40% per hundred-weight as measured as P2O5 (p. 2, ¶ [0018]). The plant growth regulator could be Thidiazuron (TDZ), also called 1-phenyl-3-(1,2,3-thiadiazol-5-yl)urea, which is a 1,2,3-thiadiazol-5-yl-urea derivative, in an amount ranging from about 0.5-10 ppm per hundred-weight (p.2, ¶ [0031]-[0032]). Davison indicates about 0.1-1% micronutrients, like zinc, iron, and copper, can be included in the composition (p. 4, Claims 1 and 5). Furthermore, Davison discloses the compositions are suitable for application to agricultural seeds (p. 2, ¶ [0020]) and/or to soil (p. 3, ¶ [0040]).
Davison does not explicitly teach 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Nisler would have found it prima facie obvious to prepare a composition comprising 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and a nitrogen utilization enhancer, specifically phosphite, based on the teachings of Davison because Nisler indicates 1,2,3-thiadiazol-5-yl derivatives, like 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea, can be used on crops to increase their stress tolerance (p. 22, Example 12) and yield (p. 26, Example 16) and Davison indicates additional components, including macronutrients like phosphite, can be included in fertilizer compositions alongside a plant growth regulator like TDZ. Thus, a PHOSITA would have been motivated to substitute TBZ, which is disclosed by Davison, with another 1,2,3-thiadiazol-5-yl derivative, like 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea as taught by Nisler. Note the only structural difference between TDZ and 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea is the urea substituent, with TDZ having a phenyl group and 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea having a 2-methoxyethyl group. A skilled artisan would have predicted TDZ and 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea would have similar activity, owing to their similar structures and would have been motivated to substitute TDZ with 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea because Nisler indicates 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea lacks the “undesirable defoliating activity typical for thidiazuron” (p. 6, Lines 19-26). Furthermore, a PHOSITA would have had a reasonable expectation of success in combining 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and phosphite since Davison indicates such macronutrients provide additional benefit to the composition and suggests including additional components, like micronutrients, can be advantageous as well.
Regarding claims 2 and 8, Nisler in view of Davison teaches all of the claimed elements as stated above.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Nisler would have found it prima facie obvious to prepare a composition comprising 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and a nitrogen utilization enhancer wherein the weight ratio is 1:5000 to 1:10 based on the teachings of Davison because Davison suggests including 0.5-10 ppm per hundred-weight TDZ and 0.1-40% per hundred-weight phosphorous. Converting ppm per hundred weight to % per hundred-weight, by Examiner’s calculation, Davison indicates the composition can include 0.00005%-0.001% per hundred-weight TDZ. Thus, the ratio of the plant growth regulator to phosphorous (i.e., phosphite) disclosed by Davison is about 1:2000 to 1:40000. Since the instantly claimed ratios overlap those disclosed by Davison, a PHOSITA would have had a reasonable expectation of success in preparing a composition comprising a 1,2,3-thiadiazol-5-yl-urea derivatives and phosphite in the ratios suggested by Davison.
Regarding claims 3-5, Nisler in view of Davison teaches all of the claimed elements as stated above. Furthermore, Nisler indicates antisenescent compounds usually show an undesirable inhibitory activity on root growth, but even at high concentrations a negative effect on root growth is not observed with Nisler’s 1,2,3-thiadiazol-5-yl-urea derivatives, like 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea (p. 6, Lines 19-26). Additionally, Nisler suggests the indicated 1,2,3-thiadiazol-5-yl-urea derivatives may be used in “broad concentration ranges without negative effects” (p. 6, 28-32).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Nisler would have found it prima facie obvious to use 25 nM-100 pM 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and 10-5000 mg nitrogen utilization enhancer in the composition based on the teachings of Davison because Nisler suggests 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea is suitable for application in a broad concentration range, displaying insignificant toxicity even at high concentrations, and Davison indicates the composition may contain 0.1-40% phosphite, as measured by the concentration of P2O5.Thus, a skilled artisan would have had a reasonable expectation of success in optimizing the 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and phosphite amounts in the composition according to the amounts disclosed by Nisler and Davison in order to achieve the desired effect on plant growth and/or yield.
Regarding claims 10-11 and 19-22, Nisler in view of Davison teaches all of the claimed elements as stated above. Furthermore, Davison indicates the fertilizer composition comprises a nitrogen-containing material, as measured as elemental nitrogen, in amount ranging from about 0.1-20% per hundred-weight or per 100 pounds of fertilizer (p. 1, ¶ [0017]). The nitrogen-containing material may be ammonium nitrate, ammonium sulfate, or urea, which a skilled artisan would recognize are all fertilizers (p. 1, ¶ [0017]). Davison’s compositions also comprise a plant growth regulator, like TDZ, in an amount of about 0.5-10 ppm per hundred-weight (p. 2, ¶ [0032]).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Nisler would have found it prima facie obvious to prepare a composition comprising 0.1-95% by weight of a combination containing 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and a nitrogen utilization enhancer, 0.4-99.9% by weight of an additive like a fertilizer and/or micronutrient, and 1-99.9% by weight of an agronomically-acceptable excipient based on the teachings of Davison because Nisler and/or Davison disclose overlapping ranges. Specifically, Nisler discloses a wettable powder containing 0.5-90% by weight of an active ingredient mixture, which contains a 1,2,3-thiadiazol-5-yl-urea derivatives, and 1-40% by weight of a surfactant (p. 9, Lines 24-27). Additionally, Davison discloses the composition can contain additives such as 0.1-1% micronutrients and 0.1-10% nitrogen-containing material (i.e., fertilizer) as well as a 0.1-10% phosphorous-containing material (i.e., a nitrogen utilization enhancer, specifically phosphite) (p. 4, Claims 1-4). Thus, a skilled artisan would have had a reasonable expectation of success in preparing a composition containing said 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and phosphite-containing combination, excipients, and additives in the instantly claimed amounts because Nisler and Davison disclose similar ranges. Furthermore, a skilled artisan would have been able to optimize aforementioned amounts guided by Nisler’s and Davison’s teachings based on the desired effect on plant growth.
Regarding claim 14, Nisler in view of Davison teaches all of the claimed elements as stated above. Furthermore, Nisler teaches applying the composition in a liquid formulation in the amount of 0.005-5.0 kg per hectare (p. 10, Line 21). Additionally, Davison teaches applying the fertilizer composition at a rate of about 0.5-25 gallons per acre (p. 4, Claim 1).
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Nisler would have found it prima facie obvious to apply 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea at a rate of 100 mg/ha-2.5 g/ha and a nitrogen utilization enhancer at a rate of 25-500 g/ha based on the teachings of Davison because both Nisler and Davison disclose application rates. Furthermore, the rate disclosed by Nisler overlaps the instantly claimed application rate for a nitrogen utilization enhancer and a skilled artisan would have known to optimize the application rate for 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea based on the desired effect on plant growth and guided by the rates disclosed by Nisler and Davison.
Claims 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nisler (WO 2016/037595 A1; IDS dated 07 August 2024, Cite No. 1) in view of Davison (US 2014/0274719 A1) and further in view of Unkefer (US 2007/0105719 A1; IDS dared 07 August 2024, Cite No. 1).
With respect to claim 7, the combination of Nisler and Davison does not explicitly teach pyroglutamic acid.
Unkefer teaches a composition comprising a mixture of L- and D-pyroglutamate stereoisomers and its use in promoting plant growth and/or yield (p. 1, ¶ [0009]).
Unkefer does not explicitly teach 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Nisler would have found it prima facie obvious to prepare a composition comprising 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and pyroglutamic acid, wherein the weight ratio is 1:25 to 1:2000, based on the teachings of Davison and Unkefer because both components have been recognized in the art for their ability to promote plant growth and/or yield (MPEP 2143(I)(A)). Thus, a PHOSITA would have had a reasonable expectation of success in combining 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and pyroglutamic acid in a single fertilizer composition. Furthermore, Davison discloses fertilizer compositions containing macronutrients, like nitrogen and phosphorous, as well as a plant growth regulator, like TDZ. Thus, while Davison fails to explicitly disclose 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea or pyroglutamic acid, a skilled artisan could have optimized the ratio of each component, guided by the amounts disclosed by Davison, to prepare a fertilizer composition having the desired effects on plant growth and/or yield.
Non-Statutory 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 1-15 and 19-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,993,002 B2 in view of Davison (US 2014/0274719 A1) and of Unkefer (US 2007/0105719 A1; IDS dared 07 August 2024, Cite No. 1).
Patent ‘002 claims 1,2,3-thiadiazol-5-yl-urea derivatives, including 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea, and a method of inhibiting stress symptoms and/or senescence in plants using said derivatives.
Patent ‘002 does not claim a composition comprising 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and a nitrogen utilization enhancer, such as pyroglutamic acid and/or phosphite.
Davison teaches fertilizer compositions containing macronutrients, micronutrients, a plant growth regulator, and optional additional components (p. 1, ¶ [0015]). The macronutrients may include phosphite (p. 4, Claim 3) in an amount ranging from about 0.1-40% per hundred-weight as measured as P2O5 (p. 2, ¶ [0018]). The plant growth regulator could be Thidiazuron (TDZ), also called 1-phenyl-3-(1,2,3-thiadiazol-5-yl)urea, which is a 1,2,3-thiadiazol-5-yl-urea derivative, in an amount ranging from about 0.5-10 ppm per hundred-weight (p.2, ¶ [0031]-[0032]). Davison indicates about 0.1-1% micronutrients, like zinc, iron, and copper, can be included in the composition (p. 4, Claims 1 and 5). Furthermore, Davison discloses the compositions are suitable for application to agricultural seeds (p. 2, ¶ [0020]) and/or to soil (p. 3, ¶ [0040])..
Davison does not explicitly teach 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea.
Unkefer teaches a composition comprising a mixture of L- and D-pyroglutamate stereoisomers and its use in promoting plant growth and/or yield (p. 1, ¶ [0009]).
Unkefer does not explicitly teach 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea.
A PHOSITA would have been motivated to prepare a composition comprising 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and a nitrogen utilization enhancer as disclosed by Davison because Davison indicates additional components, including macronutrients like phosphite, can be included in fertilizer compositions alongside a plant growth regulator. A PHOSITA would have had a reasonable expectation of success in in combining 1-(2-methoxy-ethyl)-3-[1,2,3]thiadiazol-5-yl-urea and additional components, like phosphite, since Davison indicates such macronutrients provide additional benefit to the composition and suggests including further additional components, like micronutrients, can be advantageous as well.
Because claims 1-15 and 19-22 in the instant application would have been obvious over claims 1-18 of U.S. Patent No. 9,993,002 B2 in view of Davison and Unkefer, claims 1-15 and 19-22 in the instant application are not patentably distinct from claims 1-18 of U.S. Patent No. 9,993,002 B2.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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