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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18, in the reply filed on 05/04/2026 is acknowledged. Additionally, Applicant’s election of 2,2-dimehtyl-4-hydroxymethyl-1,3-dioxolane as the species of solvent is acknowledged. Accordingly, claims 19-21 are withdrawn as being drawn to a nonelected invention and claims 7, 9, and 13 are withdrawn as being drawn to a non-elected species.
Status of Claims
Claims 1-21 are amended and claim 22 is canceled. Claims 7, 9, 13, and 19-21 are withdrawn as set forth above. Claims 1-6, 8, 10-12, and 14-18 are examined on the merits herein.
Priority
The instant application filed 05/24/2024, is a 371 filing of PCT/EP2022/083214, filed 11/24/2022, which claims foreign priority to EP21210154.7, filed 11/24/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/03/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 6 objected to because of the following informalities: in the second line Applicant’s amendments have crossed through the word “is” following R4. This is assumed to be a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
1. Claim 2 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation of the microorganisms listed in claim 1, and the claim also recites a narrower group consisting of only a subset which is the narrower statement of the limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Additionally, the phrase “in particular” renders the claim indefinite since it is unclear if the limitations following this phrase are part 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.
1. Claims 1-6, 8, 10-12, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 20110033436 A1, 02/10/2011, IDS dated 07/03/2024), hereinafter Chen, in view of Schnabel (WO 2013153030 A1, 10/17/2013, PTO-892), hereinafter Schnabel, and Proulx et al. (WO 2020104612 A1, 05/28/2020, IDS dated 07/03/2024), hereinafter Proulx, as evidenced by Evonik. (2025). Technical Data Sheet for AEROSIL® R 202 (PTO-892), hereinafter Evonik.
Chen discloses stable aqueous spore-containing chemical formulations comprising at least one spore in a mixture of water and at least one water miscible solvent (abstract).
Regarding claims 1 and 12: The agriculturally acceptable stable aqueous formulation comprising (a) at least one spore, (b) a water miscible solvent , and (c) balance water ([0013]). The water miscible solvent is a polar, organic solvent selected from various glycols, alcohols, glycerol, DMSO, N-methyl pyrrolidone etc. ([0019]-[0020]; claim 7-8). The spore may be a bacterial species spore from the genus Bacillus ([0013]-[0016]; claims 1-4) or a fungal species spore of the genus Beauveria, Paecilomyces, or Trichoderma ([0018]; claim 6). In one embodiment, the formulation further comprises a stabilizing amount of at least one suspension aid ([0075]; claims 10-12), which provides rheology control and lubrication for the spore suspension concentrate ([0075]). Customary formulations may be prepared from the resulting formulations which include suspension-emulsion concentrates ([0079]). Example 2 specifically teaches a liquid spore suspension prepared with a Bacillus firmus powder and Aerosil R972 as a silica suspension aid and propylene glycol as a solvent ([0092]).
Regarding claims 2 and 3: As discussed above, Chen teaches bacterial and fungal spores from the genera Bacillus, Beauveria, Paecilomyces, and Trichoderma, as well as a specific example comprising Bacillus.
Regarding claim 14: The formulation further comprises a surfactant (abstract; [0044]; Examples; claims 10-11).
Regarding claim 16: The formulation may further comprise a insect control agent, pesticide and/or fungicide ([0022]; [0026]; claims 10-11 and 14), with Example 3 specifically teaching a spore chemical combo using Clothianidin and Example 4 teaching a spore chemical combo using an insecticide and a nematicide.
The teachings of Chen differ from that of the instant invention in that Chen does not explicitly teach a dioxolane-based solvent nor fumed silica surface-treated with polydimethylsiloxane, as recited in claims 1 and 12, and further defined in claims 4-6, 8, 10-11, and 15.
Schnabel teaches a solvent of the formula (A) as a solvent in a composition comprising a pesticide (abstract). Formula (A) has the following formula:
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(p. 1), which reads on the dioxolane-based solvent of claim 1. Schnabel teaches that it is very difficult to identify new solvents for agrochemical compositions comprising a pesticide, because such solvents should meet various requirements: good solvency for the pesticides, low phytotoxicity to the crops, low toxicity to humans, low flammability, compatibility to the application equipment of the farmers, low cost, and low environmental impact. Especially polar solvents are required which could substitute N-methylpyrrolidone, DMSO, or dimethylacetamide, which are not based on renewable resources. An object of Schnabel is to provide a composition comprising pesticide, which overcomes these disadvantages (p. 1, para. 2). Such an object is achieved by using a solvent of formula (A) above (p. 1, para. 3). Specifically suitable solvents of formula (A) include that of (A4):
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(p. 2, 6), which further reads on the dioxolane-based solvent of claims 4-6, 8, and 12. The compositions are usually in the form of agrochemical formulations, with suspensions concentrate (SC) being a preferred example (p. 7, para. 7-8).
Proulx teaches the stabilization of biological compositions with high colony-forming units (abstract). Traditionally, aqueous formulations containing microbes or other biologically active materials are difficult to stabilize within the shelf life of a typical suspension concentrate formulation. However, the compositions of Proulx aim to lower the overall formulation barrier by creating a biological composition with both a higher activity level (CFU) and stability (low change in CFU over time). A more stable composition lowers the formulation hurdles required to generate a usable product that is suitable for use in an agricultural field application. The advantages of the compositions of Proulx allow them to be formulated into both liquid and dry agrochemical formulation types. Examples of these formulation include SCs (Suspension Concentrates) ([0026]). The microorganisms include those of the Genera Bacillus, Beauveria, Paecilomyces, Isaria, and Metarhizium (p. 4, 1.21; [0023]; claim 14 and 41). The microorganisms are loaded onto the surface of a substrate which may further comprise a second substrate as an outer layer. In one embodiment the second substate is a fumed silica such as AEROSIL® R202 or AEROSIL® R972 silica ([0037]; claim 19). In several examples AEROSIL® R 202 silica is added to the final powder at 1 % g/g ([0067]). Samples that are mixed with AEROSIL®R 202 silica are seen to be more stable than those without. The addition of AEROSIL® R 202 silica helps to improve the stability of the spore powder and extends the shelf-life of the powder ([0073]). Adding AEROSIL® R 202 silica is the most effective way to improve long-term thermal and humidity stability ([0076]). Aerosil R 202 is a fumed silica surface treated with polydimethylsiloxane, as evidenced by Evonik, therefore reading on the rheology modifier of claims 1 and 12. Aerosil R 202 also has a specific surface area (BET) of 80 – 120 m2/g, as evidenced by Evonik, which reads on BET specific surface area of claims 10-12.
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention to incorporate the dioxolane solvent of Schnabel into the formulation of Chen since such a solvent is known and routine in the art as taught by Schnabel. Chen teaches the use of water miscible, polar organic solvents. The solvents of Chen are also water miscible polar organic solvent, specifically having good solvency, low phytotoxicity, low flammability, low cost, and low environmental impact. Thus, one of ordinary skill in the art could have substituted the solvent of Chen with the known dioxolane solvent of Schnabel to predictably yield the instant invention. Furthermore, the dioxolane solvents of Schnabel have the beneficial properties above and are good alternatives to N-methylpyrrolidone and DMSO solvents, which are taught by Chen. It would have also been obvious, given the benefits of Schnabel’s dioxolane solvents, to use these known solvents in a similar product such as that of Chen to improve it in the same way as taught by Schnabel. As such, the dioxolane-based solvent of claim 1 is obvious.
It would have been further prima facie obvious to one of ordinary skill in the art to select the dioxolane solvent of Schnabel represented by formula (A4), since it is a known and routine dioxolane solvent in the art. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. As such, the instantly elected structure of the dioxolane-based solvent, as defined in claims 4-6, 8, and 12, is obvious.
Second, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention to incorporate the Aerosil R202 of Proulx into the combined formulation of Chen and Schnabel above since Aerosil R202 is a known and routine silica stabilizer in the art as taught by Proulx. Chen teaches a specific formulation utilizing Aerosil R972 as a silica suspension aid. Both Aerosil R972 and Aerosil R202 are known and effective hydrophobic fumed silica stabilizers as taught by Proulx, specifically in regards to microorganism formulations for agriculture. Thus, one of ordinary skill in the art could have replaced the Aerosil R972 of Chen with the Aerosil R202 of Proulx via simple substitution to predictably yield the instant invention. Additionally, Aerosil R202 is taught by Proulx to improve the stability of spore powder and extend its shelf-life. One of ordinary skill in the art could have therefore mixed the spore powder of Chen with the Aerosil R202 of Proulx during formulation to improve the stability of Chen’s formulation in the same manner as taught by Proulx. As such, the rheology modifier (i.e., Aerosil R202), as defined in claims 1 and 10-12, is obvious.
Regarding claim 15, the formulation of Chen comprises 2 to 90% w/w of a water miscible solvent ([0013]) and Schnabel teaches compositions comprising between 10% and 80% by weight of solvent of the formula (A) (p. 2, final paragraph). I would have been prima facie obvious to one of ordinary skill in the art to provide the dioxolane solvent of Schnabel at an amount within either of the ranges taught by Chen or Schnabel since these are known and effective amounts at which to incorporate a solvent. Both of the ranges taught by Chen and Schnabel overlap with the instantly claimed range of solvent (i.e., > 40%). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Furthermore, it is well within the abilities of an ordinary artisan to optimize the amount of solvent in the composition depending on the desired concentration and solubility of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed range of claim 15 through no more than routine experimentation using the broader ranges of Chen and Schnabel as a guide. 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. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claims 17 and 18, Chen further teaches methods of treating a plant wherein the formulation can be applied to the crop by means of a suitable device, such as a spraying device, but also commercial concentrated compositions which need to be diluted before they are applied onto the crop ([0080]). Chen teaches that the formulation comprises a surfactant in order to minimize foaming of the composition upon physical mixing or dilution into water ([0044]). Schnabel further teaches that in most cases, the compositions are to be diluted prior to application in order to prepare the so-called tank mix. The dilute composition is usually applied by spraying or fogging (p. 7-8, bridge paragraph). Thus, it would have been prima facie obvious to one or ordinary skill in the art to dilute the combined formulation of Chen, Schnabel, and Proulx prior to administration since this is a known and routine process in the art as taught by Chen and Schnabel. One of ordinary skill in the art could have formed a diluted composition ready for use with the combined formulation of Chen, Schnabel, and Proulx according to known methods to predictably yield the active formulation of claims 17 and 18.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modifications since Chen, Schnabel, and Proulx all teach formulations and methods for stabilizing agricultural actives that may be formulated as suspension concentrates. Additionally, Chen teaches formulations comprising water miscible solvents similar to those of Schnabel and a hydrophobically modified fumed silica (i.e., Aerosil R272) similar to the Aerosil R202 of Proulx. Thus, one of ordinary skill in the art would have a reasonable expectation of success in combining the elements of Schnabel and Proulx above with the formulation of Chen and using such a formulation in similar methods.
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.
1. Claims 1-6, 8, 10-12, and 14-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, and 15 of copending Application No. 18/712,230 in view of Proulx as evidenced by Evonik. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Proulx.
Copending claim 1 recites a liquid carrier concentrate comprising at least one beneficial microorganism selected from the group consisting of Bacillus, Streptomyces, Beauveria, Trichoderma, Metarhizium, Paecilomyces, Isaria, Baculovirus, Azospirillum, Penicillium and Rhizobium and at least one solvent, this solvent being a compound of formula (I), which reads on a dioxolane-based solvent. The concentrate further comprises at least one rheology modifier (Copending claim 12). The copending claims also define an agricultural active formulation comprising the liquid carrier concentrate (Copending claim 15). The copending claims differ from those of the instant invention in that they do not explicitly recite a fumed silica surface-treated with polydimethylsiloxane, as defined in instant claim 1. Proulx teaches compositions that aim to lower the overall formulation barrier by creating a biological composition with both a higher activity level (CFU) and stability (low change in CFU over time). The microorganisms include those of the Genera Bacillus, Beauveria, Paecilomyces, Isaria, and Metarhizium (p. 4, 1.21; [0023]; claim 14 and 41). The microorganisms are loaded onto the surface of a substrate which may further comprise a second substrate as an outer layer. In several examples AEROSIL® R 202 silica is added to the final powder at 1 % g/g ([0067]). Samples that are mixed with AEROSIL®R 202 silica are seen to be more stable than those without. The addition of AEROSIL® R 202 silica helps to improve the stability of the spore powder and extends the shelf-life of the powder ([0073]). Adding AEROSIL® R 202 silica is the most effective way to improve long-term thermal and humidity stability ([0076]). Aerosil R 202 is a fumed silica surface treated with polydimethylsiloxane, as evidenced by Evonik. It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention to incorporate the Aerosil R202 of Proulx as the rheology modifier of the copending claims since Aerosil R202 is a known and routine silica stabilizer in the art as taught by Proulx. One of ordinary skill in the art could have replaced the rheology modifier of the copending claims with the Aerosil R202 of Proulx via simple substitution to predictably yield the instant invention. Additionally, Aerosil R202 is taught by Proulx to improve the stability of spores and extend their shelf-life. One of ordinary skill in the art would have therefore been motivated to use Aerosil R202 as the rheology modifier since it is known to improve stability of microorganisms.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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