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
Pursuant to the amendment dated 11/21/2025, claim 39 has been cancelled. Claims 1-27 had been cancelled previously. Claims 28-38 and 40-46 are pending. Claims 41-43, 45, and 46 stand withdrawn without traverse.
Claims 28-38, 40 and 44 are under current examination.
All rejections not reiterated have been withdrawn.
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.
Claims 28-30, 32-38, 40, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Coombs (Thesis, Biotechnology Department of Microbiology and Infectious Diseases, School of Medicine, Faculty of Health Sciences, Flinders University, publication date: 01/01/2004; cited in the IDS filed 09/30/2022) in view of Seiskari (US2008/0107689; 05/08/2008).
With regard to claim 28, Coombs discloses solid state fermentation for production of actinomycete spores (page 169). In an example, the actinomycete are Streptomyces grown on various forms of oats and eventually combined with seeds in a slurry, resulting in coated seeds (page 170-172). With regard to the various intended outcomes recited in instant claims 28 ,37, 38 and 40, Coombs discloses the purpose of coating the seeds to be for biocontrol (i.e. “protection from seed borne pathogens or phytopathogenic microorganisms”). Moreover, the examiner considers the intended outcomes recited in the instant claims to be inherent in the method of Coombs because seeds are coated with the same organism that provides protection against seed borne pathogens as the instant invention. The examiner notes that the claims do not recite a specific limitation on the degree of potency required for methods falling within the scope of the instant claims. Claims 37, 38, and 40 do not require any specific potency because the comparative seeds are not specifically described. For example, the comparative seeds can have any amount of thiram present with any or no coating excipients. For this reason, the examiner considers claims 37, 38, and 40 to effectively read on any degree of potency. Finally, as the objective of the prior art is to provide seeds coated with an effective amount of beneficial Streptomyces, it would have been obvious to maximize the coating potency, e.g. by selecting an effective coating polymer, as described on page 175.
With regard to claim 28, Coombs discloses storing the coated seeds for one month and that the Streptomyces organisms remain highly viable after this storage period.
Seiskari discloses that solid state formation of beneficial microorganisms (0008, abstract, title), including Streptomyces (0023), results in organisms that can remain stable for as long as 12 months (0014).
It would have been prima facie obvious for one having ordinary skill to determine the amount of time Coombs’ coated seeds could remain viable by testing different storage durations. One having ordinary skill in the art would have been motivated to do so in order to maximize the circumstances under which the coated seeds could be useful and had reasonable expectation of success because Coombs discloses good stability after one month, and Seiskari discloses that solid state fermentation can achieve organisms that remain viable for many months. For this reason, the examiner does not consider the limitation of instant claim 28 requiring at least four months of storage to patentably define over the cited prior art.
With regard to claim 29, as the Streptomyces were produced by solid state fermentation, just as in the instant application, the examiner considers the stability to be an inherent characteristic. Moreover, Coombs discloses little change in viability after storage for up to 1 month (table 5.3, page 178).
With regard to claim 30, seeds are slurried with the actinomycete (i.e. the Streptomyces described in the preceding section) in the presence of xanthan gum (i.e. an adhesive polymer; page 175).
With regard to claim 32, as noted above 1% xanthan gum solution was used to slurry the seeds.
With regard to claim 33, the spores are slurried simultaneously with the seeds (page 175).
With regard to claim 34, the seeds are dried after mixing with the slurry (page 175).
With regard to claim 35, the seeds are coated with 10^7 cfu/g (page 175).
With regard to claim 36, the seeds are wheat seeds (page 175).
With regard to claim 44, Seiskari discloses stable microbial inoculants and methods for their production (title) and in an example, discloses solid state fermentation of Streptomyces sp strain K61 bacterium (Mycostop; 0065-0069).
It would have been prima facie obvious to use the Streptomyces sp strain K61 disclosed by Seiskari in Coombs’s method of coating seeds because one having ordinary skill in the art would have recognized this strain as suitable. See MPEP 2144.07.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Coombs (Thesis, Biotechnology Department of Microbiology and Infectious Diseases, School of Medicine, Faculty of Health Sciences, Flinders University, publication date: 01/01/2004; cited in the IDS filed 09/30/2022) and Seiskari (US2008/0107689; 05/08/2008) as applied to claims 28-30, 32-38, 40, and 44 above, and further in view of Suslow et al. (US4,751,081; issue date: 06/14/1988).
With regard to claim 31, Coombs does not disclose the listed adhesive polymers.
Suslow discloses that bacteria may be applied as part of a seed coating composition missed with, inter alia, xanthan gum, methylcellulose, polyvinyl pyrrolidone, or dextrins (col 7, lines 40-43).
It would have been prima facie obvious to use methylcellulose, polyvinyl pyrrolidone, or dextrins in place of or in combination with the xanthan gum disclosed by Coombs because these substances were known to serve the same purpose at the time the instant invention was filed. See MPEP 2144.06.
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Insomuch as the arguments traversing the anticipation rejection under 35 USC 102 are relevant to the obviousness rejection supra, they are addressed as follows:
On page 11, Applicant argues that Coombs’ disclosure of applying a raw fermentation slurry containing fragmented oat substrate to wheat seeds does not anticipate the claimed coating comprising a distinct, harvested, formulation-grade spore product. On pages 11-12, Applicant argues that an unpurified fermentation mash such as that allegedly disclosed by Coombs would vary widely in stability and performance. Applicant argues that Coombs applies a wet inoculum containing irregular substrate fragments, water, and biomass. Applicant asserts that the claims require a SSF derived spore composition applied as a coating i.e. a defined layer having controlled solids content, adherence, and stability. On page 12, Applicant argues that Coombs does not disclose spore stability on coated seed spore counts on coated seed, analysis of drying conditions, demonstration of the claimed stability metrics.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (e.g., SSF derived spore composition applied as a coating i.e. a defined layer having controlled solids content, adherence, and stability) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Additionally the examiner points out that Applicant has provided no data to establish that Coombs’ invention is less storage stable, Coombs provides evidence that the composition is, in fact, storage stable (for one month, table 5.3 as referenced in the rejection and discussed further below), and the wording of the claims does not currently exclude anything allegedly present in Coombs’ seed coating such as fragmented oat substrate.
On page 12, Applicant argues specifically Coombs does not disclose storage of coated seeds for at least 4 months as required by the instant claims.
This limitation has been addressed by the new grounds of rejection above.
On page 15, Applicant argues that Seiskari requires of spores in inoculant formulations not their stability on seeds, and Applicant argues this is different.
As Seiskari is cited as a secondary reference in the current grounds of rejection, the examiner points out that the stability described by Seiskari would have been interpreted by the artisan of ordinary skill to reflect, at least partially, that the spores were prepared by solid state fermentation, as this is the main focus of Seiskari’s invention and described by Seiskari as providing these benefits. For example “SSF is commonly used for the production of microbial inoculants, biological control agents in particular, since it is an efficient way of obtaining high densities of durable spores” (emphasis added; 0018).
On page 12, Applicant argues that they have demonstrated that the coated seeds produced by the claimed methods maintained their viability and functionality over time. On page 18, Applicant argues that Coombs does not disclose the storage of coated seeds for any length of time prior to planting of seeds.
The examiner respectfully disagrees: On page 178, Coombs states “Table 5.3 shows the dilution plate counts for the washed seed at 1 week and one month. The table shows that very little decrease in viability was observed between the samples at 4 days and 1 month. This indicates that the actinomycete spores are resistant to desiccation and are able to persist on the seed at ambient temperature.” (Emphasis added.) Thus, Coombs discloses testing seed storage for at least one month. It would have been obvious to one of ordinary skill to determine how many months the seeds could be safely stored without substantial loss of efficacy as noted in the rejection, as this determines the duration and conditions under which the product remains useful.
On page 18, Applicant argues that the instant inventors have found that Streptomyces spp. spores produced by solid state fermentation are more viable than those produced by liquid submerged fermentation when coated on seeds. Applicant cites experiments reported in the instant specification as supporting the above and asserts that this finding was surprising.
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, the examiner respectfully disagrees that the finding that seeds coated with Streptomyces spp. prepared by solid state fermentation would have been unexpected to the artisan of ordinary skill because both Coombs and Seiskari establish that the superior stability/durability of Streptomyces derived from solid state fermentation over those from liquid fermentation had been recognized as of the instant effective filing date. Moreover, the experiments reported in the specification do not reflect a side by side comparison to the closest prior art or a nexus between what is missing from the prior art and the allegedly surprising improvement. The only difference between Coombs and the instant invention as currently claimed is a step of storing the seeds after coating for at least 4 months. No evidence exists to establish that this difference in methodology results in a superior invention to that described by Coombs. Instead, the experiments in the specification compare solid state fermentation to liquid fermentation; however, as noted supra, this advantage had been recognized as of the instant effective filing date.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617