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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 20-38 in the reply filed on 8/28/2025 is acknowledged.
Status of the Claims
Claims 20-38 and 65-102 are pending. Claims 20-38 are under current examination. Claims 65-102 are withdrawn without traverse from consideration.
Withdrawn Claim Objections and Rejections
All objections of record pertaining to claims 27-29 have been withdrawn in view of the amendments to the claims filed 12/24/2025.
All rejections under 35 U.S.C. 112(b) and 102 have been withdrawn in view of amendments to the claims filed 12/24/2025.
All rejections not reiterated have been withdrawn.
Claim Objections
Claim 28 objected to because of the following informalities:
Claim 28 recites the limitation “polysorbate” twice-once in line 2 and a second time in line 4.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 12/24/2025 have necessitated the new grounds of rejection.
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 20, 22-25, 28, 30, and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Shuyan (CN11328803A, publication date 6/26/2020, referencing machine translation, of record) in view of Li et. al. (Food Hydrocolloids, pg. 368-375; publication year: 2013, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 20, Shuyan discloses a microcapsule of Bacillus thuringiensis bacteria wherein the microcapsule is comprised of a layer-by-layer assembly of chitosan and sodium alginate. The first layer is comprised of chitosan and the second layer is comprised of sodium alginate. There may be 3-6 layers comprising the capsule wall (pg. 7 Example 1, Preparation of HBF-1 cell microcapsules with HBF-1 cell as the core). Shuyan also teaches that Bacillus thuringiensis bacteria is an environmentally friendly biological insecticide (pg. 1 Background technique). With regards to the “noncovalent bond” limitations of instant claim 20, the prior art teaches the same cationic and anionic polymers as claimed and therefore, the noncovalent bond properties of the microcapsule are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” The instant specification defines agricultural agent to include an insecticidal agent [10], therefore the Examiner considers the Bacillus thuringiensis bacteria to read on the "agricultural agent" limitation of the instant claim.
Regarding claims 22 and 24, Shuyan discloses a microcapsule of Bacillus thuringiensis bacteria wherein the microcapsule is comprised of a layer-by-layer assembly of chitosan and sodium alginate. The first layer is comprised of chitosan (pg. 7 Example 1, Preparation of HBF-1 cell microcapsules with HBF-1 cell as the core).
Regarding claims 23 and 25, Shuyan discloses a microcapsule of Bacillus thuringiensis bacteria wherein the microcapsule is comprised of a layer-by-layer assembly of chitosan and sodium alginate. The second layer is comprised of sodium alginate. (pg. 7 Example 1, Preparation of HBF-1 cell microcapsules with HBF-1 cell as the core).
Regarding claim 28, Shuyan teaches the relevant limitations of claim 20 above.
Regarding claim 30, Shuyan discloses a microcapsule of Bacillus thuringiensis bacteria wherein the microcapsule is comprised of a layer-by-layer assembly of chitosan and sodium alginate. The first layer is comprised of chitosan and the second layer is comprised of sodium alginate. There may be 3-6 layers comprising the capsule wall (pg. 7 Example 1, Preparation of HBF-1 cell microcapsules with HBF-1 cell as the core). Shuyan also teaches that Bacillus thuringiensis bacteria is an environmentally friendly biological insecticide (pg. 1 Background technique). The Examiner considers the term biologically active agent to encompass the insecticidal Bacillus thuringiensis bacteria embraced by Shuyan.
Regarding claim 35, Shuyan discloses a microcapsule of Bacillus thuringiensis bacteria wherein the microcapsule is comprised of a layer-by-layer assembly of chitosan and sodium alginate. The first layer is comprised of chitosan and the second layer is comprised of sodium alginate. There may be 3-6 layers comprising the capsule wall (pg. 7 Example 1, Preparation of HBF-1 cell microcapsules with HBF-1 cell as the core).
Regarding claims 36 and 37, Shuyan discloses a microcapsule of Bacillus thuringiensis bacteria wherein the microcapsule is comprised of a layer-by-layer assembly of chitosan and sodium alginate. (pg. 7 Example 1, Preparation of HBF-1 cell microcapsules with HBF-1 cell as the core).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 20 and 28, Shuyan does not teach the inclusion of a non-ionic surfactant in the microcapsules. However, this deficiency is cured by Li.
Li teaches that including a non-ionic surfactant can be used to modulate the charge and size of chitosan-alginate electrostatic complexes (pg. 374, Conclusion). The non-ionic surfactants capable of rendering this change include Tween 20 (i.e. a polysorbate; pg. 370, Results and Discussions).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 20 and 28, it would have been prima facie obvious to one of ordinary skill in the art of filing to include a non-ionic surfactant in the microcapsule embraced by Shuyan. One would have understood in view of Li that non-ionic surfactants such as Tween 20 can be used to modulate the charge and size of chitosan-alginate electrostatic complexes (pg. 374, Conclusion). It would have been obvious to modulate the charge or size of the microcapsules embraced by Shuyan by incorporation of a non-ionic surfactant. One of ordinary skill in the art of filing would have been motivated to modulate the charge or size of the microcapsules in order to optimize the microcapsule conditions for encapsulating the bacterial cargo. The artisan of ordinary skill would have had reasonable expectation of success because Li teaches that non-ionic surfactants may be included in chitosan-alginate electrostatic complexes in order to modulate size and charge.
Claims 21, 26, 27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Shuyan (CN11328803A, publication date 6/26/2020, referencing machine translation, of record) in view of Li et. al. (Food Hydrocolloids, pg. 368-375; publication year: 2013, of record), as applied to claims 20, 22-25, 28, 30, and 35-37 above, and further in view of Huang et. al. (ACS Omega, pg. 2019-2029; publication year: 2019, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 21, 26, and 29, Shuyan, in view of Li, renders obvious the relevant limitations of claim 20 above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 21, 26, 27, and 29, Shuyan does not teach the inclusion of stabilizing agent in the microcapsules. However, this deficiency is cured by Huang.
Huang teaches that the main driving force for the buildup of polysaccharide multilayered films, such as chitosan/alginate multilayered films, is electrostatic attraction. The electrostatic attraction limits stability because changes in pH can disrupt the charge neutrality and give rise to uncontrolled selling and instantaneous disintegration of the film. This can be overcome by chemically cross-linking the film using cross-linking agents such as genipin (pg. 2019, Introduction). Huang also teaches that a sodium bicarbonate buffer may be used to regulate the pH of the solution containing the chitosan/alginate multilayered films (pg. 2020, 2.1 Materials) and that a pH that is too high or too low alters the charge balance of the film, leading to osmotic swelling (pg. 2026, 3.3 Stimuli-Responsive Behavior: pH Effect).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 21, 26, and 29, it would have been prima facie obvious to one of ordinary skill in the art of filing to include a stabilizing agent such as a crosslinker agent in the microcapsule embraced by Shuyan. One would have understood in view of Huang that crosslinking agents such a genipin can be used to overcome the inherent instability of the electrostatic attraction between chitosan and alginate in multilayered films (pg. 2019, Introduction). It would have been obvious to increase the stability of the microcapsule embraced by Shuyan by incorporation of a crosslinking agent. One of ordinary skill in the art of filing would have been motivated to include a crosslinking agent in order to overcome the inherent instability of the electrostatic attraction between chitosan and alginate. The artisan of ordinary skill would have had reasonable expectation of success because Huang teaches that crosslinking agents may be included in chitosan-alginate electrostatic films in order to increase stability.
Regarding claim 27, it would have been prima facie obvious to one of ordinary skill in the art of filing to include a stabilizing agent such as a pH regulator in the microcapsule embraced by Shuyan. One would have understood in view of Huang that pH regulates the charge balance, and therefore the osmotic swelling, of the film and that the addition of a buffer such as sodium bicarbonate solution may be used to regulate the pH of the film. It would have been obvious to add a pH regulator in order to help maintain the charge balance of the microcapsule embraced by Shuyan. One of ordinary skill in the art of filing would have been motivated to include a pH regulator in order to maintain the charge balance, and therefore the inherent stability, of the alginate-chitosan microparticle. The artisan of ordinary skill would have had reasonable expectation of success because Huang teaches that pH regulators such as sodium bicarbonate may be used to regulate the pH of an alginate-chitosan multilayer film.
Claims 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Shuyan (CN11328803A, publication date 6/26/2020, referencing machine translation, of record) in view of Li et. al. (Food Hydrocolloids, pg. 368-375; publication year: 2013, of record), as applied to claims 20, 22-25, 28, 30, and 35-37 above, and further in view of Bashir et. al. (PeerJ, pg. e2524; publication year: 2016, of record).
Shuyan renders obvious the relevant limitations of claims 20 and 30 above.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 31-33, Shuyan teaches the relevant limitations of claims 20 and 30 above. Shuyan also teaches that the microcapsules are intended to overcome the instability of Bacillus thuringiensis insecticide due to environmental factors (pg. 1, Background technique and pg. 2, Summary of the invention)
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 31-33, Shuyan does not teach an agrochemical or biologically active agent loaded into a microparticle. However, this deficiency is cured by Bashir.
Bashir teaches that Bacillus thuringiensis formulations encapsulated in light-resistant colloidosomal microcapsules confer extended Bacillus thuringiensis activity (pg. 11, Conclusions). The microcapsules are formed by a W/O Pickering emulsion (pg. 3, Fig. 1).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (colloidosomal microcapsules and alginate-chitosan microcapsules for protecting Bacillus thuringiensis from environmental degradation), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
Claims 20, 23, 25, 34, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (U.S. Patent Application No. 2012/0220454, publication year: 2012) in view of Madsen (U.S. Patent No. 9,554,502, issue year: 2017).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 20, Chen teaches a seed coating that may comprise a binder such as alginate [0041] and a film-coating layer comprising cationic guar [0040]. The coating composition may also include an active ingredient such as surfactants [0017]. The outer coating layers may be introduced sequentially to the rotating drum used to coat the seeds [0060].
Regarding claims 23 and 25, Chen teaches a seed coating that may comprise a binder such as alginate [0041] and a film-coating layer comprising cationic guar [0040].
Regarding claim 34, Chen teaches a seed coating that may comprise a binder such as alginate [0041] and a film-coating layer comprising cationic guar [0040].
Regarding claim 38, Chen teaches that seed coating techniques include a seed in a rotating pan or drum. The seed is misted with water or other liquid [0062]. The Examiner considers the term “misted” to read on the “spray coating” limitation of the instant claim.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 20, Chen does not teach the inclusion of a non-ionic surfactant. However, this deficiency is cured by Madsen.
Madsen teaches that surfactants, such as non-ionic surfactants (col. 9 line 24), may be included in seed coating compositions as a wetting agent to attract water molecules, allowing soil moisture to be absorbed in the upper hydrophobic soil layers (col. 5 lines 1-4).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 20, it would have been prima facie obvious to one of ordinary skill in the art of filing to include a non-ionic surfactant in the seed coating composition of Chen. One would have understood in view of Madsen that a non-ionic surfactant included in a seed coating composition may act as a wetting agent to attract soil moisture into hydrophobic soil layers. It would have been obvious to include such a surfactant in the seed coating composition of Chen. The artisan of ordinary skill in the art of filing would have been motivated to include a non-ionic surfactant in the seed coating composition in order to impart the wetting agent characteristics to the seed coating. One of ordinary skill in the art of filing would have had reasonable expectation of success because Chen teaches that surfactants may be included as active ingredients in the coating composition.
Response to Arguments
Applicant's arguments filed 12/24/2025 have been fully considered but they are not persuasive.
On page 12, Applicant argues that Li teaches Tween 20 as an additive to aid emulsification and droplet formation and not to stabilize a layer-by-layer coating platform protecting an agricultural agent; thus, Li is not teaching the claimed element. This is not found persuasive. 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 (i.e., a non-ionic surfactant as a stabilizing agent) 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). Furthermore, the amended claims do not recite a function for a non-ionic surfactant and simply recite that the non-ionic surfactant is present in the composition. Furthermore, in response to applicant's argument that there is no teaching of a non-ionic surfactant as a stabilizing agent, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore, the argument is not persuasive and the rejection is maintained.
On page 12, Applicant argues that there is no teaching, suggestion or motivation in the cited references to include a non-ionic surfactant as a stabilizing agent into an electrostatically assembled layer-by-layer coating platform for agricultural uses. This is not found persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Li teaches that non-ionic surfactants can be used to modulate the charge and size of chitosan-alginate electrostatic complexes (pg. 374, Conclusion). The artisan of ordinary skill would have therefore been motivated to include a non-ionic surfactant in order to modulate the charge or size of the microcapsules taught by Shuyan. Furthermore, in response to applicant's argument that there is no teaching that a non-ionic surfactant would stabilize rather than disrupt or screen the electrostatic interactions central to layer-by-layer assembly, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Therefore, the argument is not persuasive and the rejection is maintained.
On page 13, Applicant argues that the proffered combinations lack a reasonable expectation of success because the role and placement of a non-ionic surfactant with a layer-by-layer stack is not taught in the art and would present unpredictable effects on layer integrity and release kinetics. This is not found persuasive. The Examiner respectfully draws attention to MPEP 2143.02 (I) which states: “reasonable expectation of success can be implicitly shown via the prior art teachings or as part of the obviousness analysis”. As described above, Li teaches that non-ionic surfactants can be used to modulate the charge and size of chitosan-alginate electrostatic complexes (pg. 374, Conclusion). The artisan of ordinary skill would have therefore been motivated to include a non-ionic surfactant in order to modulate the charge or size of the microcapsules taught by Shuyan. The effect of a non-ionic surfactant on a layer-by-layer assembly is therefore predictable because Li teaches that non-ionic surfactants modulate the charge and size of chitosan-alginate electrostatic complexes.
On page 14, Applicant argues that the instant application shows unexpected results by present that the addition of non-ionic surfactant allowed for improved release of eugenol. This is not found persuasive. 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.
Differences in results are in fact unexpected and unobvious: The evidence of unexpected results amounts to an improved release of eugenol when Tween-80 is included in the coating platform., However, as demonstrated by Imani et. al., the addition of Tween-80 to a chitosan film decreases the particle size of chitosan and therefore increases the release of the drug contained therein (pg. 80, 3.2 Release Profile: Effect of Ratios). It would have therefore been obvious that the addition of Tween-80 to the chitosan-alginate particles of the instant invention would also result in decreased particle size, and therefore increased payload release. The evidence of allegedly unexpected results are therefore not unexpected or unobvious.
Differences are of both practical and statistical significance: The evidence of unexpected results amount to in increased release of eugenol in the presence of Tween-80 are therefore of practical significance. However, there is no statistical analysis provided for the release data present in the instant application. Therefore, the differences are not of statistical significance.
Evidence of unexpected properties must be in commensurate scope with the claims: The invention, as claimed, embraces the coating platform with any concentration of any non-ionic surfactant recited by the instant claim 28. However, the evidence of unexpected properties is limited to a demonstrated improvement in eugenol release at only one concentration of Tween-80, 0.25%. Bhunchu et. al. teaches that the encapsulation efficiency, particle size, zeta potential, and nanoparticle yield of chitosan-alginate nanoparticles is dependent on the concentration of non-ionic surfactant present and upon the species of non-ionic surfactant itself (pg. 67, 3.1 Effects of type and concentration of surfactant and Tables 1 and 2). Therefore, the evidence of unexpected results is not in commensurate scope with the claims because unexpected results are demonstrated for only one non-ionic surfactant at one concentration.
Additionally, no side-by-side comparison to the closest prior art is provided to establish unexpectedly superior performance. There is no nexus between the purportedly unexpected property and the differences between the instant invention, as claimed, and the closest prior art. Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
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 ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617