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
Claims 1-3, 9, 12-18, 20-28 and 32-48 are pending in a response dated 10/07/2025 wherein claims 22-28, 32-42, 45 and 46 have been withdrawn. Accordingly, claims 1-3, 9, 12-18, 20, 21, 43, 44, 47 and 48 are being examined.
Withdrawn objection/ rejections:
Applicant's amendments and arguments filed 10/07/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejection and/or objection are either reiterated or newly applied. They constitute the complete set of rejection and/or objection presently being applied to the instant application.
New grounds of rejection --- as necessitated by amendment
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Claims 1-3, 9, 12-18, 20, 21, 43, 44, 47 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Reap et al. (WO2017/143130A1, IDS of 05/18/2021, citation is obtained from the corresponding US2019/0045704A1, IDS of 05/18/2021) further in view of Eiben (US2017/0295799A1, IDS of 05/18/2021) as evidenced by Evonik, Sipernat®22 (publication: 2017-10).
Applicant claims the below claims 1 and 43 filed on 10/07/2025:
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For examination purpose, claim 43 recites product-by-process limitation of “prepared by the process of claim 22”. but the limitation is not seen as structurally limiting the instant composition because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See also MPEP 2113 reads “Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” Further, as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Accordingly, in the instant case, it is interpreted that claim 43 recites a dried biological composition of instant claim 1.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Reap discloses a method for coating seeds with biological materials such as bacteria (elected species), fungi (e.g., yeasts and molds), parasites, recombinant vectors, and viruses (abstract and [0072], [0077], [0079]) wherein the method includes applying a moistening liquid to moisten seeds, and coating them with an effective amount of a dry composition wherein the dry composition contains the said biological materials, one or more saccharides such as xanthan gum, gum acacia, gellan gum, CMC, alginic acid, chitosan, collagen, etc. ([0016]) or disaccharide such as trehalose, sucrose, lactose, etc. ([0013]), one or more carboxylic acid salts and one or more hydrolyzed protein, and filler material such as hydrophilic silica (e.g., hydrophilic fumed silica); the dried composition has a water activity no more than 0.4, 0.35, 0.3, 0.2 or 0.1 ([0058]) which may read on the claimed moisture content of 0.01 to 8% or 3.1 to 7.0% (instant claim 1 – moisture content); the moistening liquid comprises a moistening polymer such as polyvinyl alcohol (PVA), polyvinylpyrrolidone (PVP) having below about 0.4 initial water activity and the dry composition contains oligosaccharides, disaccharides etc. ([0086] and claim 1 of prior art) and ((instant claims 1(in part), 2 (water activity), 18, 43 and 44); the microorganisms of biological materials include Bacillus subtilis, Lactobacillus, Bacillus spp. ([0082]) which reads on the claimed elected species of bacteria (instant claims 2, 3 and 14 - microorganism); the microorganisms on the coated seeds have initial viability of at least 5 logs (=106 CFU) of colony forming units per gram of seeds at 40C, 33% RH for 30 days or more (Fig. 5, [0076] and claim 2 of prior art) which overlaps the instant range of greater than 107 CFU/g (=at least 1.0x 107 CFU/g) or 7.2x105 CFU/g (instant claims 2, 20, 47 and 48 - CFU); the biological material is present in an amount of between about 5% and 30% ([0112]) which overlaps the instant range of 4-40% (instant claim 13); and the dry composition is provided in the form of tablet (see entire document including [0077] and [0129]) and further comprises excipients or carrier ([0068]-[0069]) (instant claim 16); and the dried composition is useful for long-term storage at certain conditions including room temperature, higher temperature such as 35C or 40C, 33% or 43% of relative humidity, long term period (see Figs. 1-4, and its relevant explanation), and the dry composition does not contain alginate encapsulator (see, e.g., the Examples) (instant claim 17).
However, Reap does not expressly teach precipitated silica substrate and its properties of instant claims 1, 2, 9, 12, 43 and 47; and other species of microorganisms of instant claims 2, 14 and 15. The deficiencies are cured by Eiben as evidenced by Evonik Sipernat®22.
Eiben teaches a composition essentially free of water comprising a substrate selected from silica such as fumed silica (e.g., AEROSIL), precipitated silica, or silica gel; a polyether-modified trisiloxane, and biological control agent such as fungal microorganism such as spore forming fungus (abstract, [0010], [0030]-[0031], [0035]-[0036], [0099]-[0100], claim 1 of prior art); the fungal microorganism is placed on the silica network without reducing fungus spore sedimentation, providing long term storage stability ([0030]) and thus the silica such as precipitated reads on the claimed substrate (1) and the fungal microorganism on the silica reads on the claimed component (2) wherein the fungal microorganism can contain moisture between 0.3 and 8% ([0040]) 6% or 9% (e.g., Table 6), and Eiben also discloses dried conidia covered culture substrate itself ([0066]) that may read on the claimed dried biological composition because the term “dried” would embrace 0% or free from liquid or moisture which is close enough to or overlaps the claimed range of 0.01 to 8%, the precipitated silica has a specific surface area of 50 to 500m2/g ([0038]) which overlaps the instant range of 2-600m2/g or 400-600m2/g, and its example includes e.g., Sipernat® ([0038]) wherein Evonik evidences Sipernat®22 is a specific product range of precipitated silica has specific surface area 180m2/g which overlaps the instant range of 2-600m2/g (instant claim 2 – specific area), particle size d50 is 120 microns which is within the claimed range of about 50 to 150 microns (instant claim 1 – particle size), temped density of 245g/l, and has a high absorption capacity together with a good flowability (page 1 of Evonik), and as supported by instant specification at Tables 2-3, Sipernat®22 has pore volume 0.92 cc/g as measured by BJH method which is within the claimed range of 0.01 to 1.29cc/g and touches 0.92 cc/g (instant claims 1, 2, 9, 12, 43 and 47 – precipitated silica and properties); the fungal spore powder is used in an amount of 0.5 to 40%, e.g., about 3 to 40% ([0068]) or 10-22% ([0095]) which overlaps or inside the instant range of 4 to 40% (instant claim 13); the microorganism as a biological control agent includes Beauveria bassiana, Coniothyrium minitans, Paecilomyces lilacinus, Aschersonia aleyrodis, Beauveria brongniartii, Hirsutella thompsonii, Isaria fumosorosea, Isaria sp., Lecanicillium muscarium, Lecanicillium sp., Metarhizium anisopliae, Metarhizium anisopliae var. acridum, Nomuraea rileyi Sporothrix insectorunt, and Clonostachys rosea ([0039], [0070], [0075] and [0077]) (instant claims 14-15); the composition can be formulated as a dispersible concentrate ([0043]-[0044]) which reads on the claimed flowable concentrate, and the composition further comprise an antifoaming agent, surfactants such as polyether-modified trisiloxane ([0047]-[0048]) which reads on the claimed excipient; the composition may not require exogenous protectant such as alginate encapsulation (see the Example); and the composition is applied to seeds such as Brassica napus (e.g., rapeseed)([0098]).
It would have been obvious to replace hydrophilic fumed silica of Reap with precipitated silica having porous structure e.g., Sipernat® of Eiben as a matter of design or choice and such selection would have yielded no more than the predictable function of hydrophilic silica e.g., high absorption capacity and good flowability of precipitated silica substrate, and further it would have been obvious to further define the microorganism of Reap with those spp. of Eiben in order to provide antimicrobial activity on various species of the microorganisms.
Although the applied art, Reap in view of Eiben as evidenced by Evonik does not disclose tap density of the composition of instant claim 21, this properties would be implicit because Eiben discloses dried microorganisms on the precipitated or fumed silica plate having overlapping particle size and BET surface area as claimed, in the absence of evidence to the contrary. See case law stating that the claimed features are a natural result of the combination of elements. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (inherency is limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements; quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)).
In light of the foregoing, instant claims 1-3, 9, 12-18, 20, 21, 43, 44, 47 and 48 are obvious over Reap in view of Eiben as evidenced by Evonik.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered but are not persuasive.
Applicant argues that Eiben fails to disclose the claimed moisture content and particle size and the elected species in this application is bacteria and Eiben discloses the moisture content of the fungal microorganism; fumed silica of Eiben is non-porous (see [0030] and [0034] of Eiben) which cannot trap moisture of microorganism in its pores; precipitated silica of Eiben is used interchangeably with fumed silica as a rheology modifier and specific pore volume is not disclosed in Eiben; the particle size of Eiben below 10 microns is outside scope of the claimed range; the composition of Eiben is directed to a liquid composition, and not a solid composition while the claimed invention is more stable powder composition and therefore Eiben’s composition is necessary to be diluted by solvent; the polyether modified trisoloxane storage of Eiben only works with a spore forming microorganism; and the claimed composition provides not only a more stable powder form for storing microorganisms but also a more potent active form as compared to liquid system.
The Examiner responds that what the examiner relied on the secondary reference Eiben is for disclosing a precipitated silica and its properties, and other species of microorganisms, not relied on a liquid composition and moisture content because the primary reference of Reap discloses the claimed moisture content; Reap and Eiben disclose bacteria, fungi and other microorganism; and Eiben discloses embodiment of fungi but the applied art is not limited to embodiment because it is well-established that consideration of a reference is not limited to the preferred embodiments or working examples, but extends to the entire disclosure for what it fairly teaches, when viewed in light of the submitted knowledge in the art, to a person of ordinary skill in the art. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“the fact that a specific [embodiment] is taught to be preferred is not controlling, since all disclosures of the prior art, including unpreferred embodiments, must be considered”) (quoting In re Lamberti, 545 F.2d 747, 750 (C.C.P.A. 1976)); Eiben discloses a precipitated silica (e.g., Sipernat® as evidenced by Evonik) with the same particle size as claimed; as the applicant admitted, the fumed silica or precipitated silica both are used as rheology modifier, and thus, replacing the fumed silica of Reap with the precipitated silica of Eiben would have yielded no more than the predictable results. Please note that substitution of functional equivalents for the same function of carrying the microorganism (fumed silica taught by Reap and precipitate silica of Eiben). "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982). Also note See MPEP 2144.06(I) COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” In re Susi, 58 CCPA 1074, 1079--80, 440 F.2d 442,445 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77 (1960). As explained in Crockett, the idea of combining them flows logically from their having been individually taught in the prior art. (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)); and Reap is relied on the dried powder composition. Further, please note that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
In light of the foregoing, applicant’s arguments are not persuasive.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 9, 14 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 8 and 10 of copending application No. 18/683134.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims require dried biological composition comprising silica substrate, and microbe wherein the silica in both inventions has overlapping BET surface area, and both composition contain overlapping microbes. The difference between them is that copending ‘134 further requires sugar or sugar alcohol and resin, and however, the claimed invention uses “comprising” which does not exclude introduction of those ingredients. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending ‘134 subject matter.
This is a provisional double patenting rejection since the conflicting claims have not yet been patented.
Response to Arguments
Applicant’s argues that this rejection is traversed for the reasons of record and the final version of the claims of either application substantially overlap or are otherwise obvious over each other, and upon the identification of otherwise allowable subject matter, applicant will review the allowable claims with regard to the claims in the copending application.
The Examiner already responded to previous arguments; the reasons for final version are noted above. Since the double patenting rejection is not only remaining rejection, the rejection is maintained until the said prior art rejection is resolved.
Conclusion
All examined claims are rejected.
THIS ACTION IS MADE FINAL. 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613
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