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 .
Acknowledgement of Receipt
Applicant's response filed on 08/14/2025 to the Office Action mailed on 04/18/2025 is acknowledged.
Claim Status
Claims 1-8, 10, 12-18, 21, and 26-27 are pending.
Claims 10, 12-14, 18, and 26 are currently amended.
Claim 27 is newly added.
Claim 11 is canceled and Claims 9, 19-20, and 22-25 are previously canceled.
Claims 1-8, 10, 12-18, 21, and 26-27 have been examined.
Claims 1-8, 10, 12-18, 21, and 26-27 are rejected.
New (Modified) 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.
This rejection is modified from the previous Office Action in view of the amendments to the claims.
Claim(s) 1-8, 10, 12-18, 21, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Clary et al., (US20200093125A1, March 26, 2020) (hereinafter Clary).
Clary discloses inoculant compositions and methods for enhancing the survival and/or stability of microbial cells and/or spores in an inoculant compositions comprising microbial cells and/or spores in a carrier (Abstract). The inoculant composition may comprise Trichoderma harzianum ([0071]) in vegetative cells and/or dormant spores ([0076]). Microbial spores may be produced by any suitable method(s), including liquid fermentation, and spores may be harvested and/or concentrated using any suitable method(s) including centrifugation and filtration (i.e., wet harvesting) ([0077-0078]). Microorganisms may be incorporated into inoculant compositions in any suitable amount(s)/concentration(s) sufficient to cause a desired effect ([0079]) in about 0.1 to about 50% (by weight) of the inoculant composition ([0080]). Inoculant compositions may comprise dispersant(s) such as surfactants ([0183]), including one or more of phosphatidylserine, phosphatidylethanolamine, and phosphatidylcholine (i.e. lecithins [0198]). One or more dispersants/surfactants may be present in an amount/concentration of about 0.001 to about 25% or more (by weight) of the inoculant composition ([0245]). The composition may comprise a liquid carrier ([0115]) such as PEG 300 (i.e. ethoxylated organic liquid [0117]). Inoculant compositions may comprise suitable drying agents such as AEROSIL®, fumed silica ([0192]). The inoculant composition may be used to enhance plant yield after being coated on a seed (i.e. seed treatment [0272]). In some embodiments, inoculant compositions are spray-dried and then applied to plants/plant parts ([0285]). Clary discloses a plant seed coated with an inoculant comprising microbial cells/spores and one or more paraffin oils and/or waxes ([0010]). Inoculant compositions may comprise any suitable pesticide(s) to provide effective control against a broad spectrum of phytopathogenic fungi ([0138-0139]) including metalaxyl ([0142]). The components of the inoculant composition may be stored separately then combined prior to applying the inoculant composition to a the target medium (e.g., a plant or plant propagation material) ([0274]).The carrier of the inoculant composition may optionally comprise one or more mineral oils, nut oils and/or vegetable oils ([0371]).
The prior art discloses compositions containing phosphatidylcholine (i.e. a glycerophospholipid [0198]), Trichoderma harzianum (i.e. a fungal microorganism [0071]) in spores ([0076]) and a liquid carrier ([0115]). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding the claimed weight ratio range of claims 1 and 3, Clary teaches Trichoderma harzianum in about 0.1 to about 50% (by weight) of the inoculant composition and phosphatidylcholine in an amount/concentration of about 0.001 to about 25% or more (by weight) of the inoculant composition. The resulting weight ratio range of phosphatidylcholine to Trichoderma harzianum is 0.00002:1 to 250:1, which overlaps the claimed weight range ratios of 10:1 and 1:5000 and 2:1 and 1:5. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claim 8, Clary discloses that the carrier of the inoculant composition may optionally comprise one or more mineral oils, nut oils and/or vegetable oils. However, it would have been within the capabilities of one of ordinary skill in the art to formulate the preparation wherein said preparation does not contain vegetable oil by selecting an alternative oil choice, such as mineral oil, for the additional optional carrier oil, as taught by Clary.
Regarding claims 18(a) and 21, as discussed above, Clary makes obvious the limitations of claim 1(a) and the claimed weight ratio. Spores may be produced by liquid fermentation and harvested by filtration or centrifugation, meeting the limitation of non-dried fungal spores. Further, Clary teaches the components of the inoculant composition may be stored separately then combined prior to applying the inoculant composition to a the target medium and that the composition may be spray-dried before application. When combined, the teachings of Clary make the limitations of the method of the claims obvious to one of ordinary skill in the art.
Regarding claim 26, as discussed above, Clary makes obvious the limitations of claim 1. Further, Clary teaches inoculant compositions may comprise any suitable pesticide(s) to provide effective control against a broad spectrum of phytopathogenic fungi and may be used to enhance plant yield after being coated on a seed. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to use the composition of Clary in a method meeting the limitations of claim 26.
Response to Applicant’s Arguments
The rejection of Claim 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph and the rejection of claim 11 under 35 U.S.C. 103 as being unpatentable over Clary et al., (US20200093125A1, March 26, 2020) (hereinafter Clary) are moot since the claim is canceled.
The rejection of claims 10, 12-14 and 18 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of amendments to the claims.
With regard to the rejection of claim(s) 1-8, 10, 12-18, 21, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Clary et al., (US20200093125A1, March 26, 2020) (hereinafter Clary):
Applicant argues that a glycerophospholipid (e.g., lecithin) mixed with fungal spores after harvest and before drying in a weight ratio range of between 10:1 and 1:5000, as in Claim 1, demonstrates the unexpected result of enhancing the germination rate and, consequently, the survivability of fungal spores beyond what has been accomplished in the prior art. Applicant’s argument has been fully considered but found not to be persuasive. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). The instant specification discloses Examples 1-4 as evidence of the protective properties of lecithin for Trichoderma germination rates. In Example 1, the ratio of lecithin to spores was 1:10. In Examples 2 and 4, the ratio of lecithin to spores was 1:1. No ratio is disclosed in Example 3. Thus, the weight ratio of lecithin to spores of 1:10 and 1:1 evidenced by the Examples disclosed is not commensurate in scope with the claimed weight ratio range of between 10:1 and 1:5000.
Applicant argues that adding glycerophospholipids to fungal spores that require wet harvesting provides the added benefit of making the harvesting process easier. Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, Clary teaches an inoculant composition comprising glycerophospholipids and Trichoderma harzianum in vegetative cells and/or dormant spores. Microbial spores may be produced by any suitable method(s), including liquid fermentation, and spores may be harvested and/or concentrated using any suitable method(s) including centrifugation and filtration (i.e., wet harvesting). Thus, Clary discloses adding glycerophospholipids to fungal spores after wet harvesting. Further, the claims as recited do not require the added benefit of making the harvesting process easier.
Applicant argues that Examples 1 to 4 of the as-filed application demonstrate that use of a glycerophospholipid, e.g., lecithin, showed a significant protective effect during the drying process of the spores and improved the stability of the dried spores during storage. Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, Clary discloses inoculant compositions and methods for enhancing the survival and/or stability of microbial cells and/or spores in an inoculant compositions comprising dispersants such as one or more of phosphatidylserine, phosphatidylethanolamine, and phosphatidylcholine (i.e. lecithins) and that inoculant compositions are spray-dried and then applied to plants/plant parts. Further, Clary teaches that the dispersion may be used to improve any suitable microbial stability characteristic(s), including, but not limited to, the ability of microbial cells/spores therein to enhance plant yield after being coated on a seed and stored for a defined period of time prior to planting the seed ([0272]). Accordingly, Clary teaches the use of a glycerophospholipid, e.g., lecithin, for protective effects during the drying process of the spores and improved the stability of the dried spores during storage.
Applicant argues that Clary does disclose phosphatidylcholine (a specific type of glycerophospholipid) in the list of zwitterionic surfactants but numerous other suitable surfactants are also listed and glycerophospholipids as a class are not called out, resulting in a need for "mosaicking" the teachings of Clary to arrive at the presently claimed subject matter. Applicant’s argument has been fully considered but found not to be persuasive. A rejection made under 103 and does not need to exemplify all embodiments, only suggest. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2123. Clary teaches the use of phosphatidylcholine, which is a glycerophospholipid. Thus, it would have been obvious to formulate the composition of Clary comprising phosphatidylcholine, a glycerophospholipid.
Applicant argues that Clary does disclose Trichoderma strains within lists of numerous other microbial strains in paragraph and appendix A, with no pointer as to why Trichoderma might be selected in favour of any other, resulting in a need for "mosaicking" the teachings of Clary to arrive at the presently claimed subject matter. Applicant’s argument has been fully considered but found not to be persuasive. A rejection made under 103 and does not need to exemplify all embodiments, only suggest. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2123. Clary teaches the use of Trichoderma strains. Thus, it would have been obvious to formulate the composition of Clary comprising Trichoderma strains.
Applicant argues that Clary obtains the desired spore stability with its inoculant composition comprising paraffin oil and/or wax, as demonstrated in Examples 1-9 of Clary, there is no motivation in Clary that would lead one of skill in the art to test any of the vast number of molecules provided in the laundry list of Clary to add to its inoculant composition to enhance spore stability. Applicant’s argument has been fully considered but found not to be persuasive. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). Clary teaches the use of surfactants such as phosphatidylcholine, which is a glycerophospholipid. Thus, it would have been obvious to formulate the composition of Clary comprising phosphatidylcholine, a glycerophospholipid.
Applicant argues that a skilled person would not pick glycophospholipids from the long laundry list of different categories (with each category further listing numerous options) of molecules disclosed in Clary, to add to an inoculant composition to enhance spore stability with any reasonable expectation of success. Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above.
Applicant argues that Clary does not teach a preparation comprising glycerophospholipid and spores of a fungal microorganism in a weight ratio range of between 10:1 and 1:5000. Applicant’s argument has been fully considered but found not to be persuasive. Clary teaches Trichoderma harzianum in about 0.1 to about 50% (by weight) of the inoculant composition and phosphatidylcholine in an amount/concentration of about 0.001 to about 25% or more (by weight) of the inoculant composition. The resulting weight ratio range of phosphatidylcholine to Trichoderma harzianum is 0.00002:1 to 250:1, which overlaps the claimed weight range ratios of 10:1 and 1:5000 and 2:1 and 1:5. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
For the foregoing reasons the rejection is modified and maintained.
Conclusion
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 Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614