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 .
Priority
This application is a continuation of Application No. 16/746109 (filed on 1/17/2020), which is a continuation of Application No. 15/759660 (filed on 3/13/2018), which in turn is a national stage entry of PCT/US2016/048969 (filed on 8/26/2016). The latter application claims priority benefit of U.S. Provisional Application Nos. 62/320840 (filed on 4/11/2016) and 62/211282 (filed on 8/28/2015) under 35 U.S.C. 119(e).
Power of Attorney
There is no Power of Attorney on file and it is recommended that applicant submits one to facilitate prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 6/21/2024 complies with the provisions of 37 C.F.R. 1.97 and all references have been fully considered.
Claim Objections
Claims 90 and 99 are objected to because of the following informalities: a semicolon is used after “mercury fungicides” in line 15. To maintain consistency (with regards to how the other limitations are separated from each other), applicant should replace the semicolon with a comma.
Claim Rejections - 35 USC § 112
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.
Claims 85-104 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claims contain 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.
The claimed formulation, coated seed, and methods of use require a novel biological material, Bacillus subtilis subsp. subtilis strain AIP61892, which was deposited as NRRL No. B-67089 (lines 17-20, page 3). Since this bacterial strain is essential to the claimed inventions, it must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. Applicant must meet all the requirements of 37 C.F.R. 1.801-1.809, including providing an indication of the viability of the sample when the deposit was made.
According to the specification, the deposit will be maintained under the terms of the Budapest Treaty (lines 3-5, page 4). However, there is no indication with regards to their public availability. Thus, an affidavit or declaration by Applicant, or a statement by the attorney of record over his/her signature and registration number, stating that the biological materials will be released to the public irrevocably and without restriction or condition upon the issuance of a patent, would satisfy the requirement. Further, Applicant must state that the deposited material will be maintained for a period of 30 years, or 5 years after the most recent request date, whichever is longer.
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.
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 85-104 are rejected under 35 U.S.C. 103 as obvious over Yum et al. (Pub. No. US 2008/0267937 A1) in view of Voeste et al. (Pub. No. WO 2009/060012 A2).
Yum et al. discloses a composition for controlling plant diseases, as well as a method for controlling plant diseases using said bacterial strain (Abstract). The disclosed composition contains a pure culture of Bacillus subtilis strains KCCM 10639 and/or KCCM 10640 as an active ingredient (par. [0017], [0032]). The B. subtilis strains can be provided not only as a culture but also as an extract or spore combined with a carrier to form powders, pellets, granules, or solutions (par. [0033]).
Both B. subtilis strains have antagonistic effects on plant disease-causing microorganisms. Examples show that strains KCCM 10639 and KCCM 10640 inhibit Rhizoctonia solani, R. cerealis, and Pythium blight (par. [0053]-[0059], [0069]). When prepared as a liquid formulation and applied on turfgrass inoculated with R. solani or P. blight, the occurrence of disease was inhibited by 87-95% and 100%, respectively (par. [0077]).
Yum et al. is comparable to the instant application for the following reasons:
Regarding claim 85: the disclosed composition containing B. subtilis strain(s) is equivalent to “A formulation comprising a biocontrol agent”.
The B. subtilis strains KCCM 10639 and KCCM 10640 are analogous to “wherein the biocontrol agent is Bacillus subtilis subsp. subtilis strain AIP61892 deposited as Northern Region Research Laboratory (NRRL) No. B-67089”. The U.S. Patent and Trademark Office is not equipped to conduct experimental studies that would allow determination whether or not applicant’s strain differs, and is to what extent, from the strains disclosed by the prior art. In this case, it has been ascertained that strains KCCM 10639 and KCCM 10640, which are both B. subtilis like applicant’s strain and share the property of possessing antagonistic activity against plant disease-causing microorganisms, demonstrate a reasonable probability that one of them is identical to B. subtilis subsp. subtilis strain AIP61892. The burden of establishing novelty by objective evidence is therefore shifted to the applicant.
It should be noted that merely because a characteristic of a prior art strain is not disclosed in a reference does not make the claimed strain patentable. The prior art strain possesses inherent characteristics which might not be revealed by the tests performed in the prior art. However, the disclosed strain may be the same strain as claimed. Clear evidence that the strains of the cited prior art do not possess a critical characteristic that is possessed by the claimed strain, would advance prosecution and might permit allowance of claims to applicant’s strain.
Yum et al. is different from the claimed formulation in that the disclosed composition is not taught to be “a spray-dried formulation”.
Spray-drying, however, is a known technique for production of microbial powders as shown by Voeste et al.. Voeste et al. teaches preparing a particulate composition comprising a water-soluble carrier via well-known methods such as spray-drying (lines 27-38, page 20). Voeste et al. teaches mixing a liquid containing at least one microorganism with at least one substance suitable for forming a carrier, drying the resulting mixture in a spray-dryer heated to about >80°C, and removing the dried material from the spray-dryer at an exit temperature of about 40-85°C (lines 1-34, page 21).
Given that Yum et al. teaches formulating the disclosed strains with a carrier to form powders (par. 0033]), a person with ordinary skill in the art before the effective filing date of the claimed invention would have added a water-soluble carrier with strain(s) KCCM 10639 and/or KCCM 10640 and would have applied the known technique of spray-drying to the resulting mixture as taught by Voeste et al.. It can be predicted that a spray-dried powder comprising said B. subtilis subsp. subtilis strain(s) would be successfully produced. Obviousness is based on the rationale that applying a known technique to a known product ready for improvement yields predictable results. See MPEP § 2143 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Claim 85 is thus obvious over Yum et al. in view of Voeste et al..
Regarding claim 92: the instant claim is drawn to “A coated seed comprising a seed and a coating on the seed, wherein the coating comprises the formulation of claim 85”.
Yum et al. differs from the instant claim in that it only teaches applying the composition to soil or plants in general, but not specifically to seeds of plants.
Despite this, application of a microbial formulation to seeds in order to protect plants from diseases and/or improve plant health is known and conventional in the art. Voeste et al., for example, states that conventional seed treatment formulations include powders for dry treatment and water dispersible powders for slurry treatment, and water-soluble powders. Voeste et al. teaches preparing plant health compositions suitable for controlling pathogenic fungi as any of these formulations and applying them to seeds (lines 15-21, page 27). Examples of applicable seeds include corn, wheat, rice, barley, oats, rye, banana, sunflower, tomato, pepper, potato, cotton, soybean, sugarbeet, tobacco, cucumber, lettuce, and peas (lines 1-8, page 28).
Accordingly, a person with ordinary skill in the art before the effective filing date of the claimed invention would have applied Yum et al. and Voeste et al.’s spray-dried powder to seeds and would have expected that strain(s) KCCM 10639 and/or KCCM 10640 would protect the seeds from diseases caused by R. solani and P. blight. The rationale to support obviousness is that all claimed elements were known in the prior art and the combination would have yielded nothing more than predictable results. See MPEP § 2143 and KSR, 550 U.S. 398, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976).
Hence, claim 92 is obvious over Yum et al. in view of Voeste et al..
Regarding claims 86 and 93: the embodiment of providing strain(s) KCCM 10639 and/or KCCM 10640 in the form of spores meets “wherein the spray-dried formulation further comprises at least one of a spore, or a forespore, or a combination of cells, forespores and/or spores from NRRL No. B-67089”.
Regarding claim 87: Voeste et al. teaches that the water content of particulate formulations via methods like spray-drying is low and characterized by a water activity that is below about 0.4, 0.2, 0.1, or 0.01 (lines 4-8, page 20). There is thus reasonable expectation that Yum et al. and Voeste et al.’s spray-dried powder has such water activity, thereby satisfying “wherein said formulation is dried to a water activity of 0.3 or less”.
Regarding claim 88: the spray-dried powder of Yum et al. and Voeste et al. comprising a water-soluble carrier makes the powder wettable, which fulfills “wherein the formulation is a wettable powder or a granule”.
Regarding claims 89, 98, and 101: the formulation of claim 85 and coated seed of claim 92 are further required to comprise “a pesticide, a fungicide, an insecticide or a herbicide”.
Although Yum et al. does not teach the limitation of these claims, Voeste et al. teaches combining at least one microorganism and at least one chemical compound having plant health activity and/or crop protection activity. The combination provides the benefit of more significantly improving the health of a plant than when only either one is used (lines 28-37, page 1; lines 14-19, page 7). Applicable microorganisms include B. subtilis (lines 1-2, page 12-14), while suitable chemical compounds include insecticidal compounds and fungicidal compounds (lines 15-16).
In addition, Yum et al. teaches an embodiment of using the disclosed strains simultaneously with agricultural chemicals to which they exhibit resistance (par. [0078]). Since a working example demonstrates that strains KCCM 10639 and KCCM 10640 are resistant to several fungicides (Table 1, page 4), one with ordinary skill in the art would have added at least one chemical compound having crop protection activity like one of the tested fungicides to the spray-dried powder containing strains KCCM 10639 and KCCM 10640. It can be expected that such combination would beneficially protect a plant not only from R. solani and P. blight but also from other fungi and insects. Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention is the basis of obviousness. See MPEP § 2143.01 and KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Accordingly, claims 89, 98, and 101 are obvious over Yum et al. in view of Voeste et al..
Regarding claims 90-91 and 99-100: Voeste et al.’s teaching that applicable fungicides include azoles, strobilurins, carboxamides, heterocyclic compounds, and carbamates (pages 15-17) such as metalaxyl, flutriafol, prothioconazole, tebuconazole, azoxystrobin, pyraclostrobin, trifloxystrobin, and metconazole meets the requirements of the instant claims.
Regarding claims 94-97: Voeste et al.’s teaching of coated seeds include monocots like corn, wheat, rice, barley, oats, rye, and banana, as well as dicots like sunflower, tomato, pepper, potato, cotton, soybean, sugarbeet, tobacco, cucumber, lettuce, and peas (lines 1-8, page 28).
Regarding claim 102: the biocontrol agent in the composition of claim 101 is additionally specified to be “present in about 105 CFU/gram to about 1012 CFU/gram or in about 105 CFU/ml to about 1012 CFU/ml”.
Yum et al. does not disclose the amount of the disclosed strains.
Nonetheless, a person with ordinary skill in the art before the effective filing date of the claimed invention would have been able to find the recited amount via routine experimentation and optimization since microbial compositions are typically formulated to contain 106 to about 1012 CFU of viable microorganism according to Voeste et al. (lines 1-2, page 20) as concentrates, granules, and powders for plant application.
Regarding claims 103-104: Yum et al.’s teaching of using the disclosed composition for controlling plant diseases caused by pathogens like Rhizoctonia and Pythium in plants (par. [0017], [0053]-[0059]) is the same as “A method of controlling a plant pathogen” and “A method of growing a plant”, respectively.
Treating the soil having plants or the surface of the growing plant with the disclosed composition, wherein the composition contains an effective amount of KCCM 10639 or KCCM 10640 (par. [0034]-[0035]; claims 3-4), is akin to the step “applying to a plant, a seed, or an area of cultivation an effective amount of the formulation of claim 85, wherein said effective amount controls said plant pathogen”.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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