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 of Group 1, claims 1-3, 7, 11, 13-14, 23-25, 27, 29, 31-33 in the reply filed on 06/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 35-36, 38-39, 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
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.
Claim(s) 1, 3, 7, 13 is/are rejected under 35 U.S.C. 102(a)(1)) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Bleiel et al., (WO 2016/096929).
Bleiel et al. teaches “producing a denatured pea protein solution” and “producing microparticles having a denatured pea protein matrix” (Absract).
The “method of producing microparticles having a denatured pea protein matrix” comprises the steps of: “treating a denatured pea protein solution according to the invention or formed according to a method of the invention to form microdroplets; and cross-linking (and optionally) chelating the microdroplets to form microparticles” (p. 5, lines 26-33).
“Suitably, the step of treating the denatured pea protein solution to form microdroplets comprises the step of extruding the solution through a nozzle assembly to form microdroplets” (p. 6, lines 1-2).
“In one embodiment, an active agent is added to the denatured pea protein solution prior to droplet forming step, and optionally after the heating step, wherein the nozzle assembly typically comprises a single nozzle, and wherein the microparticles are microbeads having a continuous denatured pea protein matrix with active agent distributed throughout the denatured pea protein matrix” (p. 6, lines 5-9).
In Example 3 the active component includes “probiotics” (p. 15, lines 30-33; see also p. 19, lines 25-26, stating “Figure 5b further shows the encapsulation of probiotics in a pea protein microbead with preferably cell distribution throughout the entire microbead”). The technique of extrusion of the solution through a nozzle, described above, is “(inclusive of spray-drying nozzles and atomization wheels) during the formation of microbeads” (p. 3, lines 19-23), where the nozzles are expected to allow hot air to rapidly evaporate moisture, instantly turning solutions into fine, dry powder particles.
Claims 3 and 7 are deemed product-by-process claims. It is well settled, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (See MPEP 2113.)
Similarly, the denatured pea protein used in the prior art is the same or obvious product of the claims even though it was made by a different process.
The prior art is anticipatory insofar as it teaches the steps of preparing a protein suspension comprising denatured plant protein (i.e. pea protein), combining the protein suspension and a probiotic to form a mixture, treating a mixture to form a microparticle comprising a probiotic encapsulated in a denatured plant protein (pea protein) matrix, where the step of treating comprises forming the microparticle by spry englobing and drying the microparticle (use of spray drying nozzle).
Assuming that the prior art does not provide sufficient specificity to give rise to anticipation it would have been obvious to make microcapsules of denatured pea protein comprising probiotics, as claimed, in view of Bleiel et al.
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.
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.
1) Claim(s) 2 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bleiel et al., (WO 2016/096929) as applied to claims 1, 3, 7 and 13 above, and further in view of Akanny et al., (International Journal of Pharmaceutics, 2020).
Bleiel et al., which is taught above, differs from claims 2 and 11 insofar as it does not teach that the probiotic is hydrated nor does it teach that the suspension comprises maltodextrin and glucose.
Akanny et al. teaches a method of making enteric polymer-based microspheres comprising a probiotic, i.e. Lactobacillus rhamnosus GG.
In regard to claim 2, Akanny et al. acknowledges that “Spray-drying is far less used for probiotics encapsulation than previously mentioned gelation-based method” since the process since “cells are logically subjected to heat stress”, which is “the main critical in the inactivation of cells. Indeed, the water removal imposes important physiological constraints on cells due to the major contribution of the bound water to the stability of proteins, DNA molecules, as well as bacterial membranes” (p. 2, right column, last paragraph).
Accordingly, it would have been obvious for the probiotics of Bleiel et al. to be hydrated in order to protect the viability of the cells before processing.
Concerning claim 11, Akanny et al. further teaches adding “Carbohydrates such as maltodextrin” “[t]o enhance cell protection during drying step” (Id.) Suitable carbohydrates include “Glucidex” (p. 2, left column, 3rd paragraph), which is a mixture of maltodextrin and glucose, as per claim 11 (see Specification at p. 6, lines 1-2).
It would have been obvious to a person having ordinary skill in the art to hydrate and add carbohydrates such as maltodextrin and glucose to the probiotics of Bleiel et al. for the advantage of protecting the cells during processing, as taught by Akanny.
2) Claim(s) 14, 23-25, 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bleiel et al., (WO 2016/096929) and Akanny et al., (International Journal of Pharmaceutics, 2020) as applied to claims 1 above, and further in view of Vanderhoff et al., (US 6,544,503).
Bleiel et al. and Akanny et al., which is taught above, differs from the claims insofar as it does not teach a calcium salt or use of a fluidized bed dryer.
Vanderhoff et al. teaches “a process for the preparation of crosslinked water-swellable polymer particles” (Abstract)
Initially, Vanderhoff et al. teaches the use of “calcium chloride” (calcium salt), as ionic crosslinking agent (see col. 3, lines 45-48).
It would have been obvious to a person having ordinary skill in the art to use a calcium salt, e.g. calcium chloride, as the crosslinking agent in the method of Bleiel et al. for crosslinking the microdroplets (see p. 5, lines 26-33 of Bleiel et al.)
Vanderhoff et al. also teaches use of a “fluidized bed drier” for “industrial scale operations” (col. 12, lines 10-21).
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to use a fluidized bed drier for the industrial scale manufacturing of microparticles. The artisan would have combined the bed in the method of encapsulating probiotics in the denatured pea protein matrix (coating materials) to produce micropartices having a probiotic and a carrier, as per claims 24-25, 27.
3) Claim(s) 29, 31-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bleiel et al., (WO 2016/096929) Akanny et al., (International Journal of Pharmaceutics, 2020) and Vanderhoff et al., (US 6,544,503) as applied to claims 1 and 23 above, and further in view of Garcia et al., (LWT-Food Science and Technology, 2019).
The combination of Bleiel et al. Akanny et al. and Vanderhoff et al., which is taught above, differs from claims 29, 31-33 insofar as it does not teach adding edible oils to the suspensions.
Garcia et al. teach the “the survival and growth of seven probiotic Lactobacillus pentosus strains isolated from Alorena green table olives in the presence of vegetable-based edible oils” (Abstract).
Garcia et al. discovered that “pre-adapting the strains to the corresponding oils significantly increased their cell viabilities” (Id.)
Garcia also noted, “Several reports describe the responses of lactobacilli to stresses such as extreme temperature, pH, osmotic pressure, oxygen, and starvation, which physiologically affects the cells” (p. 154, left column, 3rd paragraph).
Accordingly, it would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add edible oils and make modifications to the pressure in the method of making microparticles of probiotics of Bleilel et al. in order to protect the viability of the probiotics, as taught by Garcia et al.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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