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 .
Claim Status
Applicants’ amendments and arguments filed 09/18/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 2, 5-6, 8, 12-16, 20-21, and 26-27 are canceled.
Claims 11, 17-19, 22-25, 29-31, and 35-39 are withdrawn.
Claims 1, and 34-35 are amended.
Claims 1, 3-4, 7, 9-10, 28, and 21-34 are examined on the merits.
Claim Interpretation
As to the limitations of claim 1, applicant is reminded this is a composition/product claim and the prior art teaches a mono-nuclear microcapsule comprising a food grade core material encapsulated withing a food-grade gastro-resistant, ileal-pH sensitive and ileal proteolytic enzyme sensitive membrane shell which is a polymerized protein selected from the group consisting of whey protein isolate, whey protein concentrate, milk protein concentrate, vegetable or plant protein, wherein the core material is a mono-nuclear core forming at least 50% of the microencapsulate and comprises a GLP-1 release stimulating agent selected from the group consisting of native dairy protein, native vegetable or plant protein, native egg protein, disaccharide, or a mixture thereof, in a solubilized form, thereby since a product is not separable from its physical properties then it necessarily teaches the mono-nuclear microencapsulate does not degrade in the duodenum. Further, the prior art teaches a composition and process for forming said composition described by applicants instant application, but applicants observation that it also ‘ does not degrade in the duodenum’ does not give it patentable weight, since it is the same composition and same process of making, as adding a characterization to a prior art patented invention is not patentable.
As to the limitations of claim 1, applicant is reminded this is a composition/product claim and the prior art teaches a mono-nuclear microcapsule comprising a food grade core material encapsulated withing a food-grade gastro-resistant, ileal-pH sensitive and ileal proteolytic enzyme sensitive membrane shell which is a polymerized protein selected from the group consisting of whey protein isolate, whey protein concentrate, milk protein concentrate, vegetable or plant protein, wherein the core material is a mono-nuclear core forming at least 50% of the microencapsulate and comprises a GLP-1 release stimulating agent selected from the group consisting of native dairy protein, native vegetable or plant protein, native egg protein, disaccharide, or a mixture thereof, in a solubilized form, thereby since a product is not separable from its physical properties then it necessarily teaches gastro-resistance, ileal-pH sensitive, and GLP-1 releasing.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 3-4, 7, 9, and 32-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wills et al. (WO2008157629A1, published 12/24/2008, hereafter Wills).
Wills teaches an encapsulated product comprising a composition comprising a labile core material; and an encapsulant on the composition (claim 19; according to the claim limitations of the instant claim 1). Wills teaches that microencapsulation is suitable for drugs, vitamins, and food supplements (page 2, lines 11-12). Wills teaches the encapsulant is prepared by a method of to include two types of polymerization, interfacial polymerization and suspension polymerization (claim 55; according to the claim limitation of the instant claim 1). Wills teaches the multiple methods of encapsulation, many including a solidifying step or a solidified product (page 18, lines 9-10; page 18, lines 21-22; page 21, lines 25-26; according to the claim limitations of the instant claim 1). Wills teaches the core material is selected from a group to include a protein (claim 34; according to the claim limitations of the instant claim 1). Wills further teaches proteins to be used to produce the encapsulating composition or the encapsulated product include casein, whey solids, whey protein isolate, soy protein, skim milk powder, hydrolyzed casein, hydrolyzed whey protein, hydrolyzed soy protein, non-fat milk solids, gelatin, zein, albumin, whey protein concentrate, β-lactoglobulin, wheat protein, pea protein, and the like (claim 29, page 7, lines 28-32; according to the claim limitations of the instant claim 1, 3, 32-33). Furthermore, Wills teaches the core material to be present in amount between about 1-50% (claim 68; according to the claim limitations of the instant claims 1, 4, and 9). Wills further defines the concentration of the core material to be present in a concentration from 1-80% by weight (page 26, lines 16-21; according to the claim limitations of the instant claims 1, 4, 7, and 9). Furthermore, Wills teaches the encapsulate can encapsulate a single discreate particle (i.e. a particle that is an encapsulant of a composition comprising a core material)(page 23, lines 28-30; according to the claim limitation of the instant claim 1). Wills teaches the encapsulated product to be a food product, specifically a food product selected from a group of liquid food products and solid food products (claims 19, and 56-57; according to the claim limitations of the instant claim 1). Wills teaches these products to be beverages, energy drinks, infant formula, liquid meals, fruit juices, liquid eggs, milk, milk products, and multivitamin syrups for the liquid products, and baby food, yogurt, cheese, cereal, powdered mixes, baked goods, food bars, and processed meats for the solid products (claims 58-59; according to the claim limitations of the instant claim 1).
Claim Rejections - 35 USC § 103
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wills et al. (WO200815629A1, published 12/24/2008, hereafter Wills in view of Reineccius (Reineccius, G. (1994). Chapter 12: Flavoring Materials Contributing to Taste. In Source Book of Flavors (Second). essay, Springer Science, hereafter Reineccius).
As outlined above, Wills teaches the microencapsulate of claim 1. Wills further teaches the addition of a flavor agent to the core material (claim 34). However, Wills fails to specifically teach a disaccharide.
Reineccius teaches sugars, specifically disaccharides, are a flavoring material contributing to taste, specifically sweetness (title and page 626, Sweetness).
Therefore, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to claim the encapsulated product to include a flavor agent as outlined by Wills with the simple substitution of disaccharide as the flavor agent as outlined by Reineccius. Simple substitution of one flavor agent for another is within the purview of the skilled artisan and would yield predictable results.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Wills et al. (WO200815629A1, published 12/24/2008, hereafter Wills in view of Rosenberg (US5601760A, published 02/11/1997, hereafter Rosenberg).
As outlined above, Wills teaches the microencapsulate of claim 1. Wills fails to the polymerized protein to be denatured.
Rosenberg teaches a milk derived whey protein-base microencapsulating agent that are easy to handle, store, have higher stability, protect the encapsulated core from deteriorating factors, prevent evaporation of volatile cores, transform liquid cores into free flowing powders, and provide greater versatility of microencapsulated products (title and abstract). Rosenberg teaches polymerization of the protein and that a high extent of polymerization results from denaturation (column 44, lines 25-29). Furthermore, Rosenberg teaches that both the core retention and microencapsulation efficiency can be improved in whey protein based wall systems by introducing heat denaturation of the proteins (column 45, lines 49-52).
Therefore, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the encapsulate composition comprising a polymerized protein membrane shell and a core material as outlined by Wills by selection of a denatured polymerized protein as outlined by Rosenberg under TSM, see MPEP 2143(G). As outlined by Rosenberg, using a denatured protein results in a high extent of polymerization and results in both better core retention and encapsulation efficiency which would motivate someone skilled in the art to advantageously combine a denatured protein with the composition of Wills as it would have a reasonable expectation of success.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Wills et al. (WO200815629A1, published 12/24/2008, hereafter Wills in view of Nickel (US5034227A, published 08/07/1991, hereafter Nickel).
As outlined above, Wills teaches the microencapsulate of claim 1. Although Wills teaches the core material protein to be albumin or pea protein or whey protein isolate or the like (page 7, lines 28-32), Wills fails to explicitly teach pea protein isolate as the vegetable protein in the core.
Nickel teaches a process for preparing product from legumes, specifically peas (title and abstract). Nickel teaches that preparing products from pea and more particularly the separation of protein and carbohydrates is useful in the food industry along with the pharmaceutical industry (column 1, lines 7-15). Furthermore, Nickel teaches it is often desirable to separate the protein in order to provide a product high in protein content that is relatively low in undesired impurities (column 1, lines 22-25). Nickel further teaches the pea protein isolate minimizes the characteristics of off flavours (column 2, lines 60-64).
Therefore, it would have been obvious to one skilled in the art before the effective filing date of the claimed invention to modify the encapsulate composition comprising polymerized protein membrane shell and a core material comprising pea protein or whey protein isolate as outlined by Wills by the use of pea protein isolate as the core material as outlined by Nickel under TSM, see MPEP 2143(G). As outlined by Nickel, an isolate pea protein provides higher protein content with less impurities and less undesirable flavours which would motivate someone skilled in the art to advantageously use pea protein isolate as the core material in the composition of Wills as it would have a reasonable expectation of success.
Response to Applicant’s Arguments
Applicant’s arguments filed on 09/18/2025 have been considered by the examiner.
In regards to Applicant’s arguments against the 35 USC § 102 rejection over Wills, Applicant first argues that Wills fails to teach the microencapsulate is “mono-nuclear” which Applicant defines as a single core. Furthermore, Applicant argues that Wills fails to teach a “polymerized protein”, providing the example that Wills teaches an encapsulant formed from a combination of hydrolyzed protein having a degree of protein hydrolysis then further selects an example from Wills’ disclosure demonstrates caramelization. Further, Applicant argues that although Wills teaches the core material is a protein, it does not specifically state the protein is a native protein or a disaccharide as instantly claimed. Additionally, Applicant argues that Wills is directed towards protection of materials that are to be included in food products and not directed towards protection of materials following ingestion.
In response to Applicant’s argument that Wills does not teach the microencapsulate having a single core, Applicant is encouraged to review the 35 USC § 102 rejection over Wills above which demonstrates that wills teaches “the encapsulate can encapsulate a single discreate particle (i.e. a particle that is an encapsulant of a composition comprising a core material)(page 23, lines 28-30). Therefore, Wills does teach a “mono-nuclear” encapsulate as defined by Applicant. In response to Applicant’s argument that Wills does not teach polymerization, Applicant is encouraged to review the above 35 USC § 102 rejection over Wills which demonstrates that Wills claims the encapsulant is prepared by a method of interfacial polymerization or suspension polymerization (claim 55) and teaches the encapsulated product include casein, whey solids, whey protein isolate, soy protein, skim milk powder, hydrolyzed casein, hydrolyzed whey protein, hydrolyzed soy protein, non-fat milk solids, gelatin, zein, albumin, whey protein concentrate (claim 29), thus teaching the encapsulate to be a polymerized protein. In response to Applicant’s arguments that Wills does not teach the core material to be a native protein, Applicant is encouraged to review the above 35 USC § 102 rejection over Wills, which demonstrates that not only does Wills claim the core material is a protein (claim 34), it also claims the core material is food product to include liquid formula, fruit juices, liquid eggs, milk, milk products, multivitamin syrups, food, yogurt, cheese, cereal, powdered mixes, baked goods, food bars, and processed meats for the solid products (claims 19 and 56-59). Therefore, Wills claims the core material to be a protein from a natural food source such as eggs. In regards to Applicant’s argument that Wills is not directed towards ingestion, it is noted that the instant claims are composition claims, therefore physical properties (i.e. better ingestion) or intended use (i.e. taken to improve ingestion) is not given patentable weight.
In summary, the examiner is not persuaded by Applicant’s arguments against the 35 USC § 102 rejection over Wills. Therefore, the rejection is maintained and updated to account for claim amendments.
In regards to Applicant’s arguments against the 35 USC § 103 rejections over Wills in view of Reineccius; Wills in view of Rosenberg; and Wills in view of Nickels, Applicant argues that no combination of Wills with Reineccius, Rosenberg, or Nickels overcomes the deficiencies of Wills as discussed in the arguments against the 35 USC § 102 rejection over Wills.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, Applicant has provided no addition reasoning as to the rejections over Wills in view of Reineccius; Wills in view of Rosenberg; and Wills in view of Nickels should be overcome.
In summary, the examiner is not persuaded by Applicant’s arguments over the 35 USC § 103 rejections of record. Therefore, the rejections are maintained and updated for claim amendments.
Conclusion
No claims 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 ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611