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 .
Notice of New Examiner
Please note that the correspondence for this application has changed.
Claim Status
The amended claim set filed 19 Aug 2026 is acknowledged. Claims 1, 3, 6, 9, 13-14, 22, 24, 27, 30-31, 34-35, 50-53, 65, and 90 are currently pending. Of those, claim 1 is currently amended, and no claims are new. Claims 65 and 90 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 Jan 2023. Claims 2, 4-5, 7-8, 10-12, 15-21, 23, 25-26, 28-29, 32-33, 36-49, 54-64, 66-89, and 91-94 are cancelled. Claims 1, 3, 6, 9, 13-14, 22, 24, 27, 30-31, 34-35, and 50-53 will be examined on the merits herein.
Priority
What follows is the examiner’s claim-by-claim analysis of effective filing date for the claims currently under examination. If the applicant disagrees with this examiner’s determination of effective filing date for any claim, the applicant may identify text within the prior applications that provides support the claimed language.
The provisional document 63/172,898 does not have support for the amendment of “vacuum drying for about 1 hour to about 8 hours”. The only use of vacuum drying was in Table 7 (pg. 50) where the sample was dried overnight. Therefore, the current claims are not fully supported as required, see MPEP 211.05. The effective filing date used for searching claims 1, 3, 6, 9, 13-14, 22, 24, 27, 30-31, 34-35, and 50-53 is 8 April 2022.
Response to Arguments
The Applicants’ arguments filed 19 Aug 2026 are acknowledged. For clarity, in this action, said arguments will be referred to as “Remarks” and the Non-Final Office Action mailed 19 Feb 2026 will be referred to as “NFOA.”
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 Aug 2026 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. A signed copy of the statement is attached with this action.
Also, the information disclosure statements (IDS) submitted on 6 Oct 2023 and 6 Nov 2025 were filed in compliance with the provisions of 37 CFR 1.97. These IDSes were considered by the previous examiner and have been re-considered by the current examiner.
Objection(s) and Rejection(s) Withdrawn
The 102 and 103 rejection over Allen 2019 and the 103 rejection over Duong et al. 2017 in view of Shabaker 1951 are all withdrawn in view of the claim amendments.
New Rejection(s)
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.
Claims 1, 3, 6, 9, 13-14, 22, 24, 27, 30-31, 34-35, 50-51, 53 are rejected under 35 U.S.C. 103 as being unpatentable over Allen 2019 (WO 2019/232049) in view of Grattepanche et al. (2013; PTO-892) and Balzarini et al. (2018; PTO-892).
Allen teaches methods of making microencapsulated plant-beneficial gram negative bacteria for treating plants comprising a cross-linked alginate microcapsule encapsulating the bacteria (e.g. [0004, 0012]; and Example 2; meeting limitations found in instant claim 1). Allen teaches the methods of making the cross-linked alginate microcapsule comprises (a) atomizing a formulation (i.e. a precursor mixture) comprising alginates, including sodium alginate; an acid, including adipic acid (i.e. an acidic buffer); neutralized with a volatile base, including ammonia (i.e. a nitrogen-containing stabilizer); an insoluble salt of a multivalent ion, including calcium carbonate; and a Gram negative bacterium; and (b) volatizing to lower the pH of the formulation thereby dissolving the insoluble salt and making it available to cross link (i.e. an intermediate formulation); sonicating (i.e. high shear mixing) the microcapsules to yield diameters ranging from 40 to 80 microns and spray-drying at 49-53°C; e.g. see [0037-40, 0043-44, 0071]; meeting limitations found in instant claims 1, 3, 6, 22, 27, 31, 34, 35, 50, and 51). Allen teaches the compositions may also be used to coat seeds and then allowed to air dry at any temperature not deleterious to the seed, typically not greater than 30°C ([0066]; also meeting limitations found in instant claim 1 with sufficient specificity). Allen teaches the wet basis moisture content was as low as 6.3% (i.e. less than 10%; see range of 6.34 to 6.86% for 0.1% Ca PPFM microcapsules; [0077]; meeting limitation found in instant claim 1). Allen teaches the bacteria include Pseudomonas (e.g. [0029, 0045]; meeting limitations found in instant claims 13 and 14). Allen teaches the compositions further comprise humectants to improve shelf life (i.e. stabilizers) including sugar alcohols, honey, molasses and/or urea (e.g. see [0050]; meeting limitations found in instant claims 6 and 9). Allen teaches the composition can be in a powder form (i.e. dry; see [0064] and Example 2).
Allen does not teach drying by air drying for about 24-72 hours, vacuum drying for about 1 hour to about 8 hours, and/or fluid bed drying for about 1 hour to about 8 hours, as in claim 1. In addition to claim 1, the differences between the prior art and the invention involve results effective variables, including (a) the aperture size of the device in dependent claim 24; (b) the temperature range for the high shear mixing in dependent claim 30; and/or (c) a water content of less than 5% in dependent claim 53.
Grattepanche is a review of techniques for producing viable probiotic cells. Grattepanche teaches that fluid bed drying and vacuum drying are well-known art-recognized alternatives to spray drying (pg. 334 “Alternative drying technologies” and sections on pg. 334 and 335). Specifically, Grattepanche teaches “Vacuum drying is a particularly suitable technology for drying oxygen and heat sensitive compounds or microorganisms. … , the fixed and manufacturing costs of vacuum drying are ca. 50% lower than those of freeze drying” (pg. 335 par. 2) and teaches that vacuum drying can be done at temperatures of 30°C or 40-45°C and only takes four hours to dry to a final moisture content of 5% (pg. 335 par. 2-3).
Balzarini is a reference that is optimizing a vacuum drying protocol. Figure 1 shows that one working in the field at the time of filing would compare different drying protocols (conventional and vacuum drying), different temperatures (60°C vs 80°C) and different drying times (samples measured at 0-500 minutes) to identify a protocol that leads to the desired final moisture level. Balzarini Figure 1 shows that the sample is below 5% water (0.05 g water/ g dry solid) when using vacuum drying at 60°C by 480 minutes (8 hours).
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the Allen microbe encapsulation by using vacuum drying and optimizing the conditions within the ranges disclosed in the art, thereby arriving at the claimed invention, because the Grattepanche teaches that these are known alternative technologies and Balzarini teaches the drying time, temperature, and final moisture levels are known to be variables that can be optimized routinely by one of ordinary skill in the art. The art teaches that temperatures to be used for vacuum drying include 30°C or 40-45°C or 60°C, teaches that the technique can be used to dry to the moisture level of 6% disclosed in Allen or to 5% as disclosed in Grattepanche, and teaches measuring many different timepoints in the range of 1-8 hours. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the use of known techniques to improve similar devices, methods or products in the same way is obvious because enhancing a particular class of devices, methods, or products has been made part of the ordinary capabilities of one skilled in the art based upon the teaching of such improvement in other situations. In the instant case, Allen teaches a “base” method for preparing an encapsulated microbial composition comprising spray-drying, and Grattepanche and Balzarini teaches a comparable method for drying a microbial composition wherein the use of vacuum drying is taught as advantageous for heat-sensitive microorganisms. Thus, one of ordinary skill in the art could have applied the known technique of Grattepanche and Balzarini to the base method taught by Allen to yield predictable results (i.e. the same advantages).
In addition, with specific regards to the aperture size, Allen teaches the use of a Buchi B290 laboratory spray-dryer (see Example 2). However, since the Office does not have the facilities for examining and comparing Applicant’s aperture size with that of the prior art reference, the burden is now upon the Applicant to show an unobvious distinction between the characteristics of the claimed aperture size with that of the prior art; See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594. Further, MPEP 2112.01 states that “When the PTO shows a sound basis for believing that the inventions of the Applicant and the prior art are the same, the Applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Furthermore, with specific regards to the water content (i.e. the concentration of water), Allen teaches the wet basis moisture content was as low as 6.3% (see [0077]) which meets the broadest reasonable interpretation of the limitation drawn to “…less than or equal to about 5%” in claim 53 with sufficient specificity; see MPEP 2144.05. In other words, 6% is about equal to 5%.
In addition, or in the alternative, with regards to all sizes, concentrations and temperatures found in instant claims 1, 24, 30, 51, and 53, MPEP 2144.05 states differences in concentration and temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical (emphasis added). "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For other cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)." In the instant case, it is the Office’s position that (A) there is no evidence of criticality for the aperture size, shearing temperature, or water content and (B) each is a results effective variable and thus there is motivation to optimize each through routine optimization; see MPEP 2144.05.
Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Response to Arguments
In the interest of compact prosecution, the arguments over the previous Allen rejection (Remarks pg. 6-7) only addressed the drying method, which is addressed by the new rejection above.
Claims 1, 3, 6, 9, 13-14, 22, 24, 27, 30-31, 34-35, 50-53 are rejected under 35 U.S.C. 103 as being unpatentable over Allen 2019 (WO 2019/232049) in view of Grattepanche et al. (2013; PTO-892) and Balzarini et al. (2018; PTO-892) as applied to claims 1, 3, 6, 9, 13-14, 22, 24, 27, 30-31, 34-35, 50-51, 53 above, and further in view of Shabaker 1951 (US 2,669,547).
The teachings of the references and the combination are set forth above.
Therefore the differences between the prior art and the reference encompass the use of high shear mixing, including milling, to produce microbeads in claims 27, 30, 51 and 52.
However, Shabaker teaches simple, improved and economical methods of pulverizing hydrogels into powders for compositions comprising particles sizes of 40 to 80 microns and having a desirable water content of about 5-10% (e.g. see columns 1, 3, 4 and Shabaker claims 1-4). Shabaker teaches any known type of grinding may be employed to make the gel beads of a desired powder size, but milling is preferred because it favors comminution to fairly uniform size range (see column 5).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the methods of making encapsulated hydrogel microcapsules, as taught by the combination above, by milling the hydrogel into gel powders of 5-10% water content and/or 40 to 80 micron diameters, thereby arriving at the claimed invention, to produce a composition with gel based microparticles of a fairly uniform size range, as taught by Shabaker. Therefore, each and every element is taught in the prior art and the combination has a beneficial result; however, the combination amounts to no more than a predictable use of prior art elements according to their established functions. The person of ordinary skill in the art would have been motivated to make the modification because milling was a preferred strategy and 5-10% water content was desirable for gel powders, as taught by Shabaker. The person of ordinary skill in the art would have had a reasonable expectation of success because Allen had already taught methods for making compositions of microorganisms encapsulated in hydrogel microbeads; and Shabaker had already taught similar methods of making hydrogel microbeads wherein milling to a desired size and water content were taught as desirable. Thus, the combination leads to expected results because each element performs the same function as it does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that applying a known technique to a known device, method or product ready for improvement is obvious because a particular known technique is recognized as part of the ordinary capabilities of one skilled in the art. In the instant case, the prior combination contains a “base” method of making encapsulated microbial compositions comprising microbead particles; and Shabaker contains a similar method for making hydrogel microbeads, wherein the techniques of milling to produce a desired size range and water content are taught as advantageous. Thus, one of ordinary skill in the art would have recognized that applying the known technique taught by Shabaker would have yielded predictable results (i.e. the same advantages) and an improved system. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
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 AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMELIA N DICKENS
Examiner
Art Unit 1645
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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