DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of t/e previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/10/2026 has been entered.
Status of Application
The Examiner acknowledges receipt of the amendments filed on 7/10/2026 wherein claims 1-3 have been amended and claims 23-26 have been added.
Claims 1-8 and 20-26 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments filed 7/10/2026 overcome 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). This rejection has been withdrawn as Zhang does not describe the encapsulated bacteria as being viable for at least 2 days.
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). This rejection is withdrawn for the reason noted under section 4 above.
New Rejections, 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, 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 22-26 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; of record), in view of Kim et al. (KR 100919508; translation provided; of record), Ceschan et al. (Mat Sci Eng C, 41, 2014, 255-266; of record) and Wackett et al. (US 2014/0051144).
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.
Zhang fails to teach the encapsulated gram-negative bacteria as being viable for a period of at least two days after spray drying/encapsulation.
Wackett describes a silica encapsulated biomaterial for use in agricultural setting wherein the biomaterial includes a gram-negative bacterium, e.g. E. coli, such that the encapsulated bacteria remains viable for a long period of encapsulation time, e.g. three weeks (see [0160, 0172]). More broadly, encapsulated biomaterials (bacteria) are taught to be viable for periods of up to about 1 year or more (see [0119]; see instant claims 24-26). Although directed to silica as an encapsulating material rather than alginate, it would be reasonable to expect similar outcomes of retaining viable gram-negative bacteria in Zhang’s alginate microparticles as it was known that such bacteria can be encapsulated within a microparticle and remain viable for an extended period of time, e.g. at least 2 days. Such a viability outcome appears to be an implicit property of encapsulation and it would be reasonable to expect such a property to convey to other systems of encapsulation like that described by Zhang.
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.
Conclusion
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
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