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 1-12 are pending and currently under examination.
Priority
Applicant’s claim to the following priority is acknowledged:
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Information Disclosure Statement (IDS)
The IDS (1) filed on 31 May 2024 has been considered by the examiner. A signed copy is enclosed.
Applicant is reminded of their duty to disclose to the Office all information known to the person to be material to patentability as defined in 37 CFR 1.56. As stated therein, “[e]ach individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in this section.”
Claim Rejections - 35 USC § 112(a)
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 1-12 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.
It is apparent that the Muscodor albus strain SA-13 is required to practice the claimed invention. As a required element, it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. If it is not so obtainable or available, the enablement requirements of 35 USC 112, a deposit of the strain may satisfy first paragraph. See 37 CFR 1.801-1.809.
If the deposit(s) have been made under the terms of the Budapest Treaty, an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the strain has been deposited under the Budapest Treaty and that the strain will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. See 37 CFR 1.808. Further, the record must be clear that the deposit will be maintained in a public depository for a period of 30 years after the date of deposit or 5 years after the last request for a sample or for the enforceable life of the patent whichever is longer. See 37 CFR 1.806. If the deposit has not been made under the Budapest treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature must be made, stating that the deposit has been made at an acceptable depository and that the criteria set forth in 37 CFR 1.801-1.809, have been met.
Amendment of the specification to disclose the date of deposit and the complete name and address of the depository is also required. As an additional means for completing the record, Applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
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.
Claims 1-12 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, 5, and 9 are drawn to a method of using a composition “comprising Muscodor albus strain SA-13 (NRRL Accession No. B-50774) fermentation.”
The term ‘fermentation’ does not clearly identify what component is present in the composition. ‘Fermentation’ ordinarily identifies a process rather than a physical component as reinforced in Applicant’s disclosure (“[t]he MBI-601 material is prepared by applying the end of fermentation whole cell broth on to sterile barley…” ([0043]); “…pearled barley is sterilized for a minimum of 30 minutes before the addition of whole cell broth from fermentation…” ([0081])). It is therefore unclear whether the claims require the composition comprise viable SA-13 cells, nonviable cells, whole-cell fermentation broth, spent fermentation medium, a supernatant, a filtrate, fermentation metabolites, volatile organic compounds produced during fermentation, or grain colonized by SA-13. These alternatives materially differ in composition and biological activity and the claims, as written, do not provide objective boundaries permitting a POSITA to determine which materials satisfy the limitation.
Claims 2-4, 6-8, and 10-12 are included in this rejection for their dependency on, containing every limitation of, and failing to cure the defects of the rejected independent claim.
Claim Rejections – 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, and 4-6 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Strobel (US PGPub. No. 2014/0086879 A1; published: 27 March 2014).
Strobel discloses Muscodor albus isolate SA-13 grown on barley grains from a culture grown on barely grains ([0200]).
Regarding instant claims 1 and 2, Strobel teaches a process of inoculating barley grains with a culture of Muscodor albus strain SA-13 grown in potato dextrose broth and mixed into soil media ([0203]-[0204]). Soybean seeds were then planted into the soil and after 10 days, Strobel reports the percent emergence, seedling height, and weight per rep were significantly greater for treatment containing Muscodor albus strain SA-13 ([0205], Table 14B).
An increase in above ground fresh weight constitutes an increase in plant biomass. The fact that Strobel describes the treatment as controlling soilborne pathogens does not distinguish the claimed method. Anticipation is based on what the prior art method does, not the motivation behind why the prior art method was performed. Accordingly, Strobel anticipates the limitations of instant claims 1 and 2.
Regarding instant claim 4, Strobel discloses treating soil with Muscodor albus strain SA-13 ([0262]-[0269]). Strobel reports the strawberry field to which Muscodor albus strain SA-13 was applied significantly increased the strawberry vigor, determined by foliar color and size, and marketable fruit weight ([0275], [0277]). An increase in strawberry vigor and marketable fruit weight therefore falls within the broadly claimed increase in plant biomass. At minimum, the increased mass of harvested strawberry fruits constitutes increased plant-produced biomass. Accordingly, Strobel anticipates the limitations of instant claim 4.
Regarding instant claims 5 and 6, Strobel discloses a composition comprising barley grains inoculated in a culture of Muscodor albus strain SA-13 grown in potato dextrose broth ([0251]). Strobel further discloses mixing the composition containing Muscodor albus strain SA-13 with Trichoderma harzianum Rifai strain T-22 and drenching soil containing soybean seeds ([0252]). The application of a composition containing viable Trichoderma harzianum inoculum to soil necessarily increases the amount of that beneficial microorganism at the time of application relative to the soil immediately before application. Applicant has identified beneficial microbes include fungi (Specification, [0092]) and Strobel expressly identifies the alternative species of Trichoderma viride as a beneficial fungus ([0172]).
Accordingly, Strobel anticipates the limitations of instant claims 5 and 6.
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 3 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Strobel (cited above).
Strobel’s disclosures are discussed above.
Regarding the limitations of instant claims 3 and 8, Strobel does not expressly disclose soaking barely in fermentation whole cell broth, removing excess liquid, and drying the barely in Study 8. However, Strobel does disclose the process involves inoculating the barley grains with a 7-day-old culture of Muscodor albus strain SA-13, breaking the grains up, and allowing the grains to air-dry until seed moisture was <10% ([0203]). Strobel also broadly discloses whole cell broth ([0117]) and identifies dried barley as a suitable carrier for a Muscodor albus strain SA-13 formulation via soaking a drying ([0096], [0124]).
Regarding claim 7, Strobel expressly discloses broccoli is a suitable target crop for Muscodor albus strain SA-13 treatment ([0125]).
The difference between the applied reference and the claimed invention is that the applied references may not teach the instantly claimed method with particularity so as to amount to anticipation. See MPEP “[t]he identical invention must be shown in as complete detail as is contained in the ... claim.” Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990). Strobel discloses various processes for distributing Muscodor albus strain SA-13 whole cell broth on barley and lists suitable plants for use in the disclosed invention, requiring the skilled artisan to choose from the disclosed methods.
The applied reference discloses the elements of the claimed method with sufficient guidance, particularity, and with a reasonable expectation of success for the skilled artisan, that the invention would be prima facie obvious to one of ordinary skill in the art. It would have therefore been obvious to a person of ordinary skill, before the effective filing date of the claimed invention, to contact or soak the barley in an amount of Muscodor albus strain SA-13 whole cell broth sufficient to distribute the inoculum over the barley, remove unabsorbed or excess broth, and dry the inoculated barley in a way sufficient to achieve Strobel’s disclosed <10% seed moisture. A person of ordinary skill would have reason to do so because: Strobel expressly identifies Muscodor albus strain SA-13 whole cell broth as an operative inoculum; Strobel expressly identifies inoculating barley using Muscodor albus strain SA-13 broth culture; soaking the grain carrier would predictably increase contact between the inoculum and porous grain surface; removing excess liquid would facilitate handling and prevent uncontrolled accumulation of free both; and drying to a low moisture content would provide storage, transport, and handling benefits Strobel teaches as benefits of dried-grain formulations.
The proposed modification would have involved no change in the principle of operation. In both Strobel and the instantly claimed method, viable Muscodor albus strain SA-13 material from a fermentation-produced broth is loaded onto barley and the resulting inoculated barely is dried for subsequent agricultural application.
Furthermore, the claimed application to broccoli involves nothing more than selecting from plants Strobel previously disclosed as suitable for use with Muscodor albus strain SA-13 inoculated barley seeds.
Therefore, instant claims 3 and 7-8 are made obvious in view of Strobel.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Strobel (cited above), and further in view of Sanchez-Lopez (“Volatile compounds emitted by diverse phytopathogenic microorganisms promote plant growth and flowering through cytokinin action,” published: 2016).
The teachings of Strobel are discussed above. Specifically, Strobel anticipates the method of increasing biomass of a plant by applying to the plant/seed/substrate an effective amount of a composition comprising Muscodor albus strain SA-13 produced by fermentation. Strobel does not expressly disclose using this method to induce early flowering in a plant, however this method is made obvious in further view of Sanchez-Lopez.
Regarding instant claim 9, Strobel discloses applying SA-13 compositions produced by fermentation to plants, seeds, and substrates used for plant growth. Strobel teaches SA-13 produces a complex mixture of fungal VOCs, including alcohols, esters, ketones, and terpenoid compounds ([0009]). Strobel further reports application of SA-13 barley increased soybean emergence, height, and fresh weight; improved strawberry plant vigor; and increased strawberry yield.
Regarding instant claims 10 and 12, Strobel expressly discloses applying barley grain inoculated with SA-13 to the substrate used for growing the plant and expressly discloses applying SA-13 product to soil used for growing strawberry plants. As discussed above, regarding claim 11, Strobel makes obvious the method of soaking barley in fermentation whole cell broth, removing excess liquid, and drying the barley.
Sanchez-Lopez teaches volatile compounds emitted by phylogenetically diverse rhizosphere and non-rhizosphere bacteria and fungi, including plant pathogens and microbes that do not normally interact mutualistically with plants, promote growth and flowering of various plant species including crops (abstract). Sanchez-Lopez also teaches VOCs from most microorganisms induced early flowering (p. 2595).
It would have been obvious to one of ordinary skill, before the effective filing date of the claimed invention, to use Strobel’s SA-13 treatment to promote or induce earlier flowering because Strobel teaches SA-13 is a prolific producer of fungal VOCs and already demonstrates exposure to SA-13 fermentation products promotes plant growth, vigor, and reproductive yield. Sanchez-Lopez provides express evidence that fungal microbial volatiles were known to accelerate flowering through effects on cytokinin levels.
Therefore, a person of ordinary skill seeking to accelerate plant growth and reproductive development would have had reason to apply Strobel’s SA-13 VOC-producing fermentation composition to a plant, see, or growing substrate to induce earlier flowering.
A person of ordinary skill would have a reasonable expectation of success because: Strobel establishes that the SA-13 material remains biologically active when applied on grain; Strobel demonstrates a plant-growth and yield response to the treatment; Sanchez-Lopez establishes that fungal VOCs can accelerate flowering; and Strobel’s SA-13 composition produces the same general classes of low molecular weight fungal VOCs implicated in microbial regulation of plant development.
Accordingly, claims 9-12 would have been obvious over Strobel in view of Sanchez-Lopez.
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.
US Patent No. 10,869,482
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,869,482 (hereinafter ‘482) in view of Strobel (previously cited) and Sanchez-Lopez (previously cited).
Although the claims at issue are not identical, they are not patentably distinct because the presently claimed methods would have been anticipated by, or obvious variations, of the methods recited in the claims of ‘482. The ‘482 patent and the present application are commonly assigned to Pro Farm Group, Inc. (formerly, Marrone Bio Innovations, Inc.).
Regarding instant claims 1, 5, and 9:
Claims 1 and 4 of ‘482 require applying an effective amount of a composition comprising SA-13 fermentation to a plant, seed, or substrate growing the plant. These are the same operative application steps recited in claims 1, 5, and 9. The ‘482 claims are directed to a method for modulating pest infestation and/or phytopathogenic infection in a plant while the instant claims are drawn to a method for increasing biomass of a plant (claim 1), a method for increasing an amount of beneficial microbes in a soil (claim 5), and a method for inducing early flowering in a plant (claim 9). Therefore, the distinction between ‘482 claims and the instant claims amounts to recitation of another result or property of the same SA-13 treatment. A person of ordinary skill would have understood that suppressing the recited soilborne pathogens predictably reduces pathogen-associated damage and thereby, increases the growth and biomass of an infected plant or induces earlier flowering. These differences are further made obvious over Strobel and Sanchez-Lopez, which collectively disclose the instantly claimed result of SA-13 fermentation-produced composition application to plants or soil.
Regarding instant claims 2-3, 6, 8, and 10-11, use of an inoculated grain does not render the claim patentably distinct. Claims 1 and 4 of ‘482 encompass applying the SA-13 fermentation with a carrier, and claims 3 and 6 of ‘482 expressly contemplate a carrier. Strobel establishes that barley grain is an expressly disclosed carrier that could be used in ‘482’s method, thereby arriving at the instantly claimed invention in claims 2, 6, and 10. Regarding the method of preparing the inoculated barley grain as recited in instant claims 3, 8, and 11, Strobel also establishes this. Therefore, it would have been obvious to perform the method claimed in the ‘482 patent using barley soaked with SA-13 whole cell broth, removing unabsorbed broth, and drying the barley. This would employ an expressly disclosed carrier and conventional carrier-loading method to practice ‘482’s application method.
Regarding instant claims 4, 7, and 12, the claims of ‘482 broadly require treatment of a plant. The selection of the plant, as instantly claimed, is made obvious by Strobel. Strobel expressly identifies the instantly claimed crops as suitable plants and specifically demonstrates SA-13 fermentation produced material on strawberry plants.
Therefore, claims 1-6 of ‘482 in further view of Strobel and Sanchez-Lopez make obvious that which is instantly claimed in claims 1-12.
Conclusion
Claims 1-12 are rejected. No claim is allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Julia A. Rossi whose telephone number is (571)272-0138. The examiner can normally be reached M-Th 7:30-5:30 (MST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571)272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIA A. ROSSI/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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