DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 11/12/2025 wherein claim 20 has been amended.
Claims 1-8 and 20-22 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 11/12/2025 overcome the rejection of claims 20 and 21 made by the Examiner under 35 USC 112(d). This rejection is withdrawn.
Applicant’s arguments filed 11/12/2025 regarding the rejection of claims 1-3, 6-8 and 22 made by the Examiner under 35 USC 103 over Zhang et al. (CN104968712; translation provided), evidenced by de Rooij et al. (Physical Review E, 1994, 49, 4, 3038-3049), in view of Kim et al. (KR 100919508) and Ceschan et al. (Mat Sci Eng C, 41, 2014, 255-266) have been fully considered by are not considered persuasive and the rejections of record are MAINTAINED for the reasons of record in the Office Action mailed 06/12/2025.
Applicant’s amendments filed 2/17/2025 overcome the rejection of claims 4 and 5 made by the Examiner under 35 USC 103 over Zhang et al. (CN104968712; translation provided), evidenced by de Rooij et al. (Physical Review E, 1994, 49, 4, 3038-3049), in view of Kim et al. (KR 100919508) and Ceschan et al. (Mat Sci Eng C, 41, 2014, 255-266) have been fully considered by are not considered persuasive and the rejections of record are MAINTAINED for the reasons of record in the Office Action mailed 06/12/2025.
In regards to the 103 rejections, Applicant asserts the following:
Zhang does not describe a supramolecular capsules made from crosslinked alginate but instead Zhang requires a “constructing unit to the one or more hoist urine guest molecule through a covalent bond”. Any use of alginic acid by Zhang is therefore optional and even then are used only as a constructing unit that is connected to the required hoist urine guest molecule by a covalent bond;
The microcapsules of Zhang are chemical delivery systems, not biological;
Zhang’s use of PEG is not for moisture control since the final use is in the context of a liquid, microfluidic environment; and
There would be no motivation from the cited prior art to produce a powder of the microcapsules described by Zhang.
In response to A, Zhang describes a crosslinked shell network forming a microcapsule. The shell network may comprise a ‘hoist urine’ crosslinking network as indicated by Applicant. However, Zhang also teaches that the shell may comprise a shell material comprising a low polydispersity material such as natural polymers like alginic acid (see page 34). However, according to Applicant, Zhang is not applicable to the present claims as the shell is to contain a ‘hoist urine’ and such would be contrary to the present claims. The Examiner respectfully disagrees because the instant claims are ‘comprising’ claims which are inclusive or open-ended and does not exclude additional, unrecited elements (such as ‘hoist urine’ shell materials). See MPEP 2111.03(I).
In response to B, Zhang teaches that the encapsulant is a material that is released from within the microparticle (see abstract). The encapsulant includes both chemicals and biological materials (see pages 40-42). Exemplified biological materials for encapsulation include microorganisms such as gram-negative bacteria (see pages 41-42). Thus, contrary to Applicant’s argument, Zhang suggests a biological delivery system as gram-negative bacteria are specifically described for inclusion within the microparticle.
In response to C, Zhang teaches that the microparticle contains a constructing unit which serves the function of improving water solubility. An exemplified constructing unit includes polyethylene glycol (see page 31 and 35). As polyethylene glycol is a chemical compound, any physical or chemical properties would necessarily be present. Thus, the property of being a humectant would necessarily be present despite being a ‘humectant’ not specifically identified by the reference.
In response to D, Zhang teaches that their microparticles may be in the form of particles such as granules (see page 37) and that the microparticles may be dried. The shortcoming of Zhang is it does not produce the dried granules/microparticles as a powder resulting from spray drying. Both Kim and Ceshan are directed to alginic acid microparticles for use in delivery of medicinal substances wherein their microparticles are made by a process of spray-drying. It would have been obvious to employ the techniques of Kim and Ceshan so as to spray dry the Zhang microparticles so as to produce a granular powder product with a reasonable expectation for success. Applicant’s arguments are not considered persuasive.
Maintained Rejections, of Record
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, 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.
Claims 1-3, 6-8, 20 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (CN104968712; translation provided; of record), evidenced by de Rooij et al. (Physical Review E, 1994, 49, 4, 3038-3049), in view of Kim et al. (KR 100919508; translation provided; of record) and Ceschan et al. (Mat Sci Eng C, 41, 2014, 255-266).
Zhang describes a supramolecular capsule made from crosslinked alginate (see pages 9 and 35) in the form of a microcapsule (see pages 8 and 12) having a diameter of 50 (to 100) microns (see page 12). The microcapsule is to encapsulate are active component such as a therapeutic compound or a cell (see pages 40 and 42) such as gram-negative bacteria (see page 42) (see instant claim 1). The microcapsule may comprise a low dispersity polymer such as polyethylene glycol (humectant according to instant claims) (see page 35) (see instant claims 3 and 22) as well as latex (implicitly includes polymer(s)) (see page 57) and polystyrene (see page 39) (see instant claim 2). It is noted that polystyrene is a ‘latex polymer’ according to de Rooij (see abstract, page 49). Zhang’s microcapsule may further include adjuvants and/or excipients such as metals, adjuvants, hormones, catalysts, adhesives and pesticides (see page 41) (see instant claim 6). The term ‘pesticide’ is considered overlapping with insecticides, nematicides and fungicides recited by instant claim 7 (see page 41). Exemplified metals include zinc and copper which are plant micronutrients (see page 39) (see instant claim 8). Zhang teaches that their particles are produced by a process including drying whereby prior to drying the microcapsules are present in an aqueous solution (see instant claim 20).
Zhang fails to teach their microparticles as being a spray-dried powder.
Kim is directed to drug loaded cross-linked alginate particles which are made by a process of spray-drying (see page 3) which results in alginate particles where the solvent used in the preparation of the particles is completely removed by the process (see page 4) thereby resulting in dried alginate particles. Thus, it would have been an obvious modification of Zhang to use spray-drying so as to produce dried drug-loaded alginate particles. The use of a known technique to a known product ready for improvement to yield predictable results is indicia of obviousness. It is also noted that being ‘spray-dried’ is a product-by-process limitation in that it defines how the product is made rather than provide any limitation to the composition itself. See MPEP 2113.
Ceschan describes alginic acid microparticles for use in the delivery of inhalable drugs. It is taught that spray drying is a technology for producing particulate systems with controlled quality by a suitable selection of the fluid feed composition and process operating conditions. Fine droplets are formed during atomization which are then dried by means of hot air, the result of which is a dried powder collection (see page 255). Thus, it would be expected that the necessary result of Kim’s spray drying process would be a powder composition and so the combination of Zhang and Kim together with Ceschan would ultimately suggest a spray dried powder comprising cross-linked alginate microcapsules suitable for encapsulating a gram-negative bacterium.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 4 and 5 are rejected under U.S.C. 103(a) as being unpatentable over Zhang et al. (CN104968712; translation provided; of record), evidenced by de Rooij et al. (Physical Review E, 1994, 49, 4, 3038-3049), in view of Kim et al. (KR 100919508; translation provided) and Ceschan et al. (Mat Sci Eng C, 41, 2014, 255-266) as applied to claims 1-3, 6-8, 20 and 22 above, and further in view of Harada et al. (US 2015/0197482).
Zhang fails to teach the PEG as having a molecular weight of about 400 Daltons.
Harada is directed to polyalkylene glycol with narrow weight distributions and dispersity. Harada teaches a polyethylene glycol of between 1-400 units, which overlaps with the instant molecular weight boundaries, exhibit a dispersity of about 1-1.4 (see [0028]). Given that Zhang desires a dispersity between 1-2, it would have been obvious to use a PEG that exhibits a dispersity within said range and as PEG having a molecular weight of 400 is encompassed by the range of PEG contemplated by Harada, such an obvious result would have been the product of ordinary skill and common sense rather than one of innovation.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 21 depends from claim 20. Claim 21 recites, “…wherein the spray-dried powder composition is granular or is contained in an aqueous liquid, a non-aqueous liquid, or an emulsion.” However, claim 20 is directed to a composition that “is contained in a liquid or slurry form.” Claim 21, which depends from claim 20, include a granular form of the composition. However, this is beyond what is included in the claim from which it depends as claim 20 requires the composition be in the form of a liquid or slurry. Granular compositions are neither a liquid or a slurry. Therefore, claim 21 fails to further limit claim 20.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
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 extension fee 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 KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611