DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 7/14/2023, 10/10/2023 and 8/8/2025 were filed timely. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
4. Claims 2,3,6 and 26 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. The terms “or more particularly” and “e.g” make the claim indefinite as it is unclear if it is a required element.
Claim Rejections - 35 USC § 103
5. 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.
6. 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.
7. Claims 1-6, 8-11, 13, 15-17, 19, 22, 25-26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over (US 2022/0248738 A1) to Kyle et al. (hereinafter Kyle) in view of (US 2014/0302135 A1) to Durvasula et al. (hereinafter Durvasula) in further view of (US 2002/0160109 A1) to Yeo et al. (hereinafter Yeo).
Kyle is directed toward methods of spray dry encapsulating microparticles having live organisms. Kyle discloses at paragraph [0024] that the composition may be spray dried to form a powder. Kyle discloses at paragraph [0024] that the organism encapsulated is a Lacticaseibacillus rhamnosus, which reads on Applicants species of bacteria. Kyle discloses at paragraph [0013] that the bacteria population is suspended in globules in an aqueous solution. Kyle discloses at paragraph [0050] that the organism may be mixed with a MFGM lipid complex. Kyle discloses at paragraph [0013] that the bacteria is coated with a protective agent SigA. Kyle discloses at paragraph [0079] that the protective compound may be 30-35%, which overlaps on Applicants range of 5 to 30%. Kyle discloses spray drying a protective coating with alginate that is crosslinked, which identical would be expected to keep alive the core 12 to 18 months. Kyle discloses spray drying a protective coating, but is silent regarding crosslinking of the coating of the bacterial agent and specific type of spray gun, coaxial that is used for spray drying.
Durvasula is directed toward methods of encapsulating microparticles having live organisms with spray drying. Kyle and Durvasula are both directed toward methods of encapsulating microparticles having live organisms with spray drying and therefore are analogous art. Durvasula teaches at paragraph [0013] that a polymer coating of alginate may be used to encapsulate one or more agent. Durvasula teaches at paragraph [0034] that the agent is a live organism. Durvasula teaches at paragraph [0037] that the polymers used includes various gums. Durvasula teaches at paragraph [0048] that the alginate based polymers may be crosslinked. Durvasula teaches at paragraph [0053] that the alginate based polymers may be crosslinked with 0.05 mol (50 mM) calcium chloride, which reads on Applicants range of 1 to 100 mM. Durvasula teaches at paragraph [0059] that the biological agents may be encapsulated by gelatins, cellulose and proteins. Durvasula teaches at paragraph [0063] that the solutions produced may be spray dried into solid particles. Durvasula teaches at paragraph [0048] that alginate concentration may be varied to control release and are useful with live organisms, which would motivate one skilled in the art to modify Kyle with the crosslinked alginate coating of Durvasula for live biological materials as it is non-toxic. Durvasula teaches spray drying and crosslinking coatings, but is silent regarding specific spray drying nozzles.
Yeo is directed toward methods of encapsulating microparticles with spray drying. Kyle and Yeo are both directed toward methods of encapsulating microparticles with spray drying and therefore are analogous art. Yeo teaches at paragraph [0013] that spray drying is used to encapsulate heat sensitive cargo, which would include live cargo. Yeo teaches at paragraph [0028] that the microcapsule is formed from an aqueous solution with a protein. Yeo teaches at paragraph [0033] that in Fig. 3 a coaxial nozzle system is used to form an encapsulant around the drug core in a pneumatic atomization mode.
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Yeo teaches at paragraph [0072] that the coaxial nozzle approach is even simpler for mass production of encapsulated materials and therefore one skilled in the art would be motivated to use a coaxial system of spray drying for mass production with easier adjustability of shell thickness and particle sizes. Yeo teaches at paragraph [0074] that the shell can be a sodium alginate that is cross linked immediately with calcium ions to form the shell, which would be expected to have the same viscosity as it is the same materials at the same temperature range. Yeo teaches at paragraph [0076] that a channel of an inner stream is engulfed by fluid from a channel of an outer stream. Yeo teaches at paragraph [0083] that the particles are jetted out using a concentric nozzle with an inner liquid A and an outer nozzle with liquid B that are jetted out with an atomized gas in the outer channel as shown in Fig 3 above. Yeo teaches at paragraph [0084] that a carrier stream is formed around the concentric nozzle to reduce particle size. Yeo teaches at paragraph [0087] that 500 mg core with 40 mg (40/500 = 8%) alginate are used to form an encapsulate that reads on 2 to 10% concentration. Yeo teaches at paragraph [0019] that heat susceptible drugs are spray dried at 90 to 150C, which reads on Applicants range of greater than or equal to 100C. Yeo teaches at paragraph [0044] that the shell may include a chitosan polymer. One skilled in the art would find it obvious and be motivated to combine the various methods discussed above to improve a mass produced bacteria that is spray dried, heat sensitive, live organism with stable storage.
It would be obvious to one skilled in the art at the time of the filing of the disclosure of Kyle in view of the teachings of Durvasula and Yeo, to modify Kyle with a coaxial nozzle and a alginate crosslinked coating that forms a prime facie case of obviousness for claims 1-6, 8-11, 13, 15-17, 19, 22, 25-26 and 28.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY D WASHVILLE whose telephone number is (571)270-3262. The examiner can normally be reached M-F 9-5.
9. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
10. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Randy Gulakowski can be reached at 571-272-1302. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEFFREY D WASHVILLE/ Primary Examiner, Art Unit 1766